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Medical devices import license number
Q：Can I sell medical devices on the Internet?
A：First, the Internet is a virtual space. It’s difficult to audit the sources, quality and sellers of medical devices by the way of existing pharmaceutical census. If there are some questions or consumer disputes, it also cannot give the explanation and operation of the demonstration by pharmacists. Based on the differential characteristics between medical devices and general merchandise, TFDA has yet to make it open to public access to ensure the health and safety of public.
Second, according to the Pharmaceutical Affairs Law Article 27, it defines only pharmaceutical firm which has pharmaceutical license (operating items including medical devices sold) can sell medical devices, but it does not approve the sale on the Internet by the range of pharmaceutical approbation.
Third, according to the Pharmaceutical Affairs Law, it will be considered by its relevant provisions, the usage and risk of medical devices, and the connection with entities of medicine in the future. They’ll consult whether to make the Internet open to sell medical devices or not to people so that to ensure the health and safety of public.
Q：Can I sell the ear thermometer on auction sites?
A：No!!
Since the Internet, catalog and television shopping channel are virtual spaces, goods are mailed to the consumer after the order. If consumers have some difficulties about the usage, the manufacturer can’t give explanations and operational demonstrations. Based on the differential characteristics between medical devices and general merchandise, TFDA doesn’t agree that people can sell medicine via the Internet or other virtual spaces. And also remind consumers to pay attention that it’s better to go to pharmaceutical firm which has pharmaceutical license to buy medical devices.
There are many places such as pharmacies, convenience stores, supermarkets, drug stores which have pharmaceutical license currently. People must be careful on the package of products or the labels should be marked the “TFDA official number” while buying medical devices like Medical Devices Import License Number 000000.
Q：How to choose and use the condom in order to achieve the prevention of sexually transmitted diseases and the function of contraception?
A：The poor quality of condom may be damaged easily when people use it. It cannot achieve the purpose of contraception, but increase the risk that spread the disease like AIDS or sexually transmitted diseases. People should pay attention to some items below while buying and choosing the condom:
(1) Selecting the qualified brand carefully. You can go to the website called “Drugs & Cosmetics License Database” to inquire the licensed product.
(2) You should notice that if there is a complete label on the carton, such as name, TFDA official number (Medical Devices Import License Number 000000 or Medical Devices Manufacture License Number 000000), the name and address of manufacturers and pharmaceutical firms, the date of manufacture or batch number, valid time and expiration date.
(3) You should notice that the label must be complete, clear and consistent of the inner and outer package.
(4) The condom is made from latex processing by natural rubber. Please store the condom in the cool place because it will be damaged easily in the environment with high temperature. Do not use the condom if it is expired.
(5) You should read the instruction manual before to use and follow.
Q：How to choose and wear contact lenses?
A：Buying and wearing contact lenses should pay attention to the following matters:
(1) Do not use the product without the license issued by the TFDA. You can go to the website called “Drugs & Cosmetics License Database” to inquire the licensed product.
(2) You should notice that if there is a complete label on the carton, such as name, TFDA official number (Medical Devices Import License Number 000000 or Medical Devices Manufacture License Number 000000), the name and address of manufacturers and pharmaceutical firms, the date of manufacture or batch number, valid time and expiration date.
(3) This kind of product should be issued by ophthalmologist’s prescription. It is better to check your eyes before wearing contact lenses, and choose the appropriate contact lenses with good quality by ophthalmologist. Other things that must be required are complying with the wearing time which is suggested by ophthalmologist, and choosing the appropriate cleaning and preserving liquid of contact lenses to do the procedure of maintenance --- cleaning, sterilizing, preserving and deproteinizing.
(4) People wearing the contact lenses may have the higher probability to get hurt of their eyes than general people because their corneas have covered by contact lenses directly for a long time. If you feel uncomfortable with your eyes or something wrong with contact lenses, please go to see the doctor immediately to have the healthy window of soul.
(5) When people buy disposable contacts, please according to the product manual to change the new one. Do not forget to change on the appropriate time for saving the money
Q：What is the function of contact lenses and how to choose and use?
A：
(1) Function: To keep the lenses clean, prevent the contamination from microorganism and to keep the lenses on the eyes moist. Categories are included: cleaning solution, enzyme cleaning tablets, wet liquid, rinse, soak preservation solution and multi-function maintenance fluid.
(2) The measures of contact lens cleaning and preservation liquid: Step to use [categories] multi-function, dual-oxygen system and other systems.
Step one: Hand-rub, multi-function solution, daily cleaning liquid, daily cleaning liquid.
Step Two: Rinse, multi-function solution, normal saline, normal saline.
Step Three: Sterilize, multi-function solution, hydrogen peroxide and soaking in preservation liquid.
Step Four: Cleaning before wearing contact lenses, and normal saline is not required.
Besides these four steps to maintenance contact lenses, you also need to use enzyme tablets to deproteinize routinely. Cleaning of contact lenses and preservation liquid can be classified into three systems above, so consumers must be able to use the appropriate medicinal liquid, doing these four steps above correctly, otherwise pathogens and sediments will cause corneas damaged.
(3) The products which declared for free hand-rub must be more careful that do not wearing contact lenses which are continuous products more than 30 days. Weekly and monthly disposable products will be more applicable. In the case of extended wearing and daily wearing of contact lenses should not omit the step of hand-rub.
(4) You should choose the appropriate product recommended by doctor. Do not use the product without the license issued by the TFDA. You can go to the website called “Drugs & Cosmetics License Database” to inquire the licensed product.
(5) You should notice that if there is a complete label on the carton, such as name, TFDA official number (Medical Devices Import License Number 000000 or Medical Devices Manufacture License Number 000000), the name and address of manufacturers and pharmaceutical firms, the date of manufacture or batch number, valid time and expiration date.
(6) You should notice the package which is intact or not when you purchase. Do not use it if there’s any damage. Besides, you should use it according to the manual’s recommendation before the expiration date, and throw it after the expiration date.
Q：What is the principle about infrared ear thermometer? What is the matter should be attention to the purchase and usage?
A：
1. Due to the temperature of eardrum and the temperature of body of the center (the hypothalamus) temperature are similar, infrared ear thermometer is using the infrared sensors to detect the heat radiation of eardrum in order to know the body's temperature.
2. Infrared ear thermometer is a medical device. To inquire the licensed product, you can go to the website called “Drugs & Cosmetics License Database” to search the information and notice the followings:
(1) You should notice that if there is a complete label on the carton, such as name, TFDA official number (Medical Devices Import License Number 000000 or Medical Devices Manufacture License Number 000000), the name and address of manufacturers and pharmaceutical firms, the date of manufacture or batch number, valid time and expiration date.
(2) You should read the manual carefully before using the device and following the instruction to use.
(3) While using the ear thermometer, it should be inserted into the ear canal entrance. The probe is aligned with the eardrum to the inner ear in order to get an accurate temperature. Due to the human ear’s canal is not linearly, you need to pull the top of the ear back when you use ear thermometer so that the ear canal will be able to be linear-shaped, and the ear thermometer are more likely to align the eardrum. Some ear thermometers have built a variety of measurement modes [such as in rectal temperature or in oral temperature prevail]. The measured values are different, so it’s better to select measurement mode before using to avoid errors.
(4) You need to use probe covers to cover some ear thermometers, or it can not measure the correct temperature. It must to be replaced before using a clean and intact covers.
(5) Due to the composition of electronic parts of ear thermometers have its valid time, the user is encouraged to use an ordinary thermometer intervals [or rectal thermometer] for comparison. If error, please contact the original manufacturer, agency or pharmacist.
Q：How should I do if I have any problem about the measured value from home-used blood glucose meter?
A：
(1) There some reasons that might cause the error of results from home-used blood glucose meter, such as the battery is dead, the password is wrong, inadequate blood, paper damp/expired/improper preservation, certain medications or food, settings of blood glucose meter or operational errors. Home self-monitoring of blood glucose meter can be used as a reference to track the disease. If someone has disease, it should follow the professional treatment by doctor in order to achieve the best health management.
(2) If you doubt that the test result from home-used blood glucose meter is not correct, it is recommended to use the original glucose control solutions to confirm the testing value and to be the first time as a self-validation. If you still have doubts, you should consult with the manufacturer/ pharmaceutical firm.
(3) The home-used blood glucose meter is used to detect small amount of blood from blood capillaries; other will be drawn the blood from venous by the hospital. Based on different samples, it cannot be compared by these two samples
Q：If people find that when defective medical devices, how should they do?
A：
(1) According to the Pharmaceutical Affairs Law Article 13 about the medical device, it refers to diagnosis, treatment, mitigation or prevention of human disease directly.
Or it is enough to affect the structure of human body and the function of the instruments, apparatus, appliances, and its attachments, accessories and parts.
(2) If people find bad situations while using the medical devices, such as: there is hair and other contaminants in the sterile package; contents and packaging specifications cannot match together; unused product that is damaged……etc. You can access to “National Medical Product Defect Reporting System” (http://recall.fda.gov.tw/) for online notification, or download the "Medical Devices Defect Reporting Statements" by mail, fax or e-mail notification.
(3) If defective medical devices caused serious adverse reactions, it should be reported to the “Taiwan National Adverse Drug Reactions Reporting Center” (https://adr.fda.gov.tw/).
(4) When you confirm the non-medical devices, you can report to the website called “Bureau of Standards, Metrology & Inspection” with merchandise accident recall website. (http://safety.bsmi.gov.tw/wSite/np?ctNode=3572&mp=65).
Q：How to determine whether the product is a new medical equipment or not?
A：It is represented that the new medical equipment has the new principles, new structures, new materials, or new material to combine for manufacturing. Its safety or efficacy of medical has not been medically proven (ie, the TFDA has not approved similar goods), or other central competent health authority to review and identify that the equipment should be categorized to new medical equipment or not. If you can cite similar products which have been approved by the TFDA at the time of inspection and registration, and it won’t be reviewed by new medical equipment. It refers to the TFDA noticed on 18 August 1999 granted the Department of Food No. 0991608423 "Medical Equipment Similar Product Determination Process and Application Instructions." to judge the similar product.
Q：Which kind of product is required to conduct domestic clinical trials?
A：When the application has been announced by TFDA inspection and registration, the item should conduct clinical trials in the country. It refers to Attachment III of the content of medical equipment management. As for other application for registration of medical equipment to conduct clinical trials in the country or not, manufacturers should be assessed (if any consideration of ethnic differences, etc.) on the product features whether there are clinical trials in domestic demand or not. When it is necessary, you can base on the notice number “0920332729” announced by TFDA in December 2, 2003, and support document letter of inquiry to TFDA.
Q：According to "Guidelines for Registration of Medical Devices in Taiwan", applying registration of medical devices shall attach pre-clinical trial and testing and original manufacturer quality control test specifications and methods, original test records, and test results report. What’s the detail about it?
A：The test data contents should include:
(1) Method: The method is based on the officially sanctioned standards or original manufacturer's methods. The method based on officially sanctioned standards should include standard names, and the method based on original manufacturer should set out the complete test procedure (SOP, test method, procedure, and protocol).
(2) Items: Test name.
(3) Specifications: Qualified or acceptable range (criteria, specification).
(4) Original record: Test value.
(5) Test results report: Test result whether is a pass or fail.
Q：Our company's product is diagnosed as X-ray machine. According to the "Guidelines for Registration of Medical Devices in Taiwan," applying registration of medical devices shall attach radiation safety information for equipment generating ionizing radiation. What’s the detail about it?
A：If there is ionizing radiation equipment, it shall attach radiation safety information which is ordered by Atomic Energy Commission (http://www.aec.gov.tw). The information should be included: Radiation safety review of the project and its corresponding radiation safety test data (i.e. IEC 60601-1-3), reviewed by TFDA forward to Atomic Energy Commission.
Telephone numbers and address of Atomic Energy Commission:
02-22322295 Mr. Lee, 02-22322196 Mr. Liu, 02-22322194 Mr. Tsai
No.80, Sec. 1, Chenggong Rd., Yonghe Dist., New Taipei City 234, Taiwan (R.O.C.)
Q：How to manage the product about breast implants which are filled with silicone?
A：
(1) Due to doubts of the safety about breast implants which are filled with silicone, TFDA announced the prohibition against the import, manufacture and sell on September 9, 1992. While TFDA is deliberating the situation of existing products technological development and relevant international management trends, it announced that breast implants filled with cohesive silicone did not belong to the usage of prohibition above in October 3, 2008. However, it should apply for registration to ensure the safety and effectiveness of marketed products.
(2) The indication of this kind of product is only for "women to do breast reconstruction surgery."
(3) In order to protect public health and safety of usage, the introduction for use (IFU) of product will attach" breast implants filled with the cohesive silicone– notice for patients before reconstruction surgery ". Physician will be asked to explain and communicate with patients fully about the potential risks and complications that might occur before surgery, and it should do the signature of both the patient and the physician.
(4) It’s better to put breast implants filled with cohesive silicone inclusion of drug safety assessment tasks and to require pharmacists to submit the safety information every half a year about the domestic usage of the product and latest news of the domestic and foreign adverse reactions to protect public safety.
Q：What’s the situation of "Standard of good clinical trial for medical devices" currently?
A：
(1) TFDA announced the "Standard of good clinical trial for medical devices" on May 30, 2007.
(2) It commissioned the project called "The training of audit personnel with clinical trials and audit matters of medical devices" to match up “Standard of clinical trial for medical devices” that the registration need and to ensure the process of testing is complied with ethics certainly, and the testing data of results are correctly credible.
(3) It commissioned the project called "The training of medical personnel with clinical trials of technique and audit matters of medical devices" via the educational course about clinical trial which can foster the professional ability of medical personnel and researcher. This project can build a good environment of clinical trial.
(4) The review system of clinical trial of medical devices case has been established gradually. When medical institutions are in the implementation of human testing case, there are some norms to follow the settings and operations of laboratories. Not only can shorten the period of preparation of the case in order to accelerate the development of domestic biotechnology industry but also can improve the quality of human testing by regulations with certificate of audition.
Q：How to classified and graded the common dental clinic equipment, such as dental clinic chair, high speed, drills and dental surgery shadowless light?
A：Guidelines are determined in accordance with the grading regulations in the Regulations Governing Management of Medical Devices. Basically refer to the regulations settings by FDA. (http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm)
(1) Dental clinic chair- Belonging to F. 6250 dental clinic chair and attachment as the first level of medical equipment.
(2) High speed, drills- Belonging to F.4200 dental device and attachments as the first level of medical equipment.
(3) Dental surgery shadowless light- Belonging to F.4630 dental surgical lights as the first level of medical equipment.
These three products is also classified as CLASS I in the United States
Q：There’s a medical device which is classified as the first level currently. Our company proposes a strict management that it should be promoted to the second level. Which organization can accept my proposal?
A：TFDA commissioned ITRI Center for Measurement to execute the research project about classify and grade of medical devices. It is welcome very much that everyone propose their recommendation about classification and grading of medical devices. Others like the public, association, academy can word to TFDA.
ITRI Center for Measurement contacted as follows:
Tel: 0800-45-8899 or 03-5743881
Fax: 03-5743092 or 03-5732299
Email Address: senwork@itri.org.tw
Address: Rm. 300, 16Department, No.321, Sec. 2, Guangfu Rd., East Dist., Hsinchu City 30011, Taiwan (R.O.C.)
Q：In subparagraph 3 of paragraph 7, the guidelines of registration increase criteria mentioned that "shall contain the situation of commissioned manufacturing". Yet every country has their own form of FSC (Certificate for Free-Sale), how should I state it?
A：There’s not a fixed form required on FSC about the manufacture from the entrusted manufacturing plant currently. If you can list the name and address of the entrusted company / entrusted manufacturing plant and show the relationship of them with the entrusted manufacturing contract to corroborated, TFDA will identify leniently.
Q：In the cases that the final packaging and testing of products are finished by entrusted company, so the entrusted company can’t submit the FSC about the name, and address of the entrusted manufacturing plant. Is this factor can be considerate by lenient terms?
A：First, you need to know the differences between parts of manufacturing outsourcing and manufacturing entrusted. If the entrusted manufacturing plant just responsible for parts of manufacturing without the entrusted relationship, then the entrusted manufacturing plant is still commissioned by the manufacturer in this case. In addition, country of origin (COO) is recognized by the national customs which is different from registration, so it cannot put them together to discuss.
Q：Can Taiwan accept the export certificate issued from USA instead of FSC?
A：It is unacceptable. Due to export certificate indicates that the product is not available to sell in the U.S., it is different by FSC.
Q：While applying registration of medical devices, the reviewers are often asked to name and address to be exactly the same. Some of countries (like Netherlands) Ltd. will appear as Oy and caused the problems to applying manufacturers. In addition, if the name of firm is different from the ISO 13485 certificate, how should I do?
A：If names of firms are the same and the difference is only in Oy and Ltd., as long as the original instructions for equality, reviewers will identify the discretion of leniency. As for the certificate of ISO 13485, it can issue the original letter by the Notified Body to explain the reasons about the differences of company’s name.
Q：When will the draft of measures simplifying the registration of new medical devices inspection be implemented? After implementation, is it available for the cases has been sent to reviewers? Is it acceptable to reduce the clinical data for the products with the same principle but with different ingredients and prescriptions? If there is a similar product listed in the application process, should this case to be converted to general medical devices review?
A：The draft measures：
(1) Due to the need of review with revised guidelines, it should be waiting until the official announcement. The draft of measures simplifying the registration of new medical devices will be announced in mid-June.
(2) The file which has been sent to reviewers before this announcement can use the simplify mode, but still depending the consideration case by case and internal sign-off.
(3) If there are sufficient documents or test data to prove the change of ingredients will not affect the safety and effectiveness of the product, then it meet the definition of similar products, clinical data can be reduced.
(4) If there are similar goods listed in the process of application, you can communicate with the TFDA. After estimating its similar characteristics and risk level of their products are not improved, it can be changed to general medical devices review. If in the case of high-risk products, it still submits clinical data and provides consultation to discuss medical devices.
Q：Can you define in detail about the "non-high-risk" and “expected performance of domestic and racial differences"?
A：
(1) If the second level of new medical devices can be excluded as four exceptional conditions, it can be considered as non-high-risk medical devices originally.
(2) Such as contact lenses, because of the corneal differences of East and West, there may be concern about racial differences. Most of the second level of medical devices compared to people without racial differences.
Note: The exceptional conditions for second level of new medical devices:
1. The differences between products which have been sale on the market and second level of new medical devices cannot prove its safety and effectiveness which were verified by the laboratory methods.
2. The devices have racial differences.
3. Intended use or indications had been requested under the listed product (or intended use, indications were reported domestic and abroad have significant adverse reactions)
4. The product has been on the U.S. and EU markets, indications of its intention applying beyond the scope of the U.S. and the EU who are approved.
Q：Is it acceptable for domestic manufacturers who have the CE mark certification to reduce TFDA plant operating check?
A：We are trying to get the recognition of the EU mutually of the efforts in the future.
Q：When applying for QSD, as the scope listed on ISO 13485 certificate is too large. Whether there are other options available to replace Notified Body Description letter or not?
A：Our GMP / QSD check login is classified items, so when the scope is too large for manufacturers to correspond to the actual class difficultly, it still made by the Notified Body Supplement.
Q：TFDA asked the company to send “electromagnetic compatibility test report”, so what’s the meant by "electromagnetic compatibility"? Why does medical electrical devices category or system need to do electromagnetic compatibility (EMC) test?
A：According to the laws of physics, moving electric field generates a magnetic field, and vice versa. We live in the environment which is filled with a variety of electrical appliances, especially lots of medical devices will be operated in hospital (there must be more medical devices in this kind of environment). It will affect safety and health of patients with the diagnosis of disease, surgery or a purpose of support the patient life, such as influenced by other devices’ electromagnetic effects, or interferes with other devices. Therefore, medical electrical devices must be carried out electromagnetic compatibility (Electromagnetic compatibility, referred to EMC) tests.
Electromagnetic compatibility tests include:
1. To confirm the usage in devices or systems do not occur electromagnetic interference beyond the provision, you need to test according to relevant standards (method) called Electromagnetic Interference (referred to EMI) test.
2. To confirm devices or systems in the surrounding electromagnetic environment still can be operated completely and will not detract from its function, you need to test according to relevant standards (method) called Electromagnetic Susceptibility (referred to EMS) test.
Q：What’s the important point that TFDA review Electromagnetic compatibility (EMC) test report carefully.
A：The key-points that TFDA require for EMC reporting are as follows:
(1) It should contain the relevant information of testing laboratory and testers’ signature (seal), in accordance with the relevant standards (method) name and year (revision), power supply specifications, testing product’s name and description, model, manufacturer's name and address. (The last four published content should be consistent with the application product)
(2) It should refer to the relevant international or regional or national standards (method). For example: Formulated by the International Electrotechnical Commission standard IEC 60601-1-2 (EMI includes: IEC CISPR 11, IEC 61000-3-2, IEC 61000-3 -3, EMS includes: IEC 61000-4-2, IEC 61000-4-3, IEC 61000-4-4, IEC 61000-4-5, IEC 61000-4-6, IEC 61000-4-8, IEC 61000 -4-11). If these items wouldn’t test completely, laboratory or the original manufacturer should explain the reason for non-testing items under the structure of standard (method). When it is necessary, it should refer to the provisions of the standards described. (For example: Vendor attached the data which is not processing to IEC 61000-3-2 project, but this standard applies to the rated voltage ≧ 220V, input current ≦ 16A / per phase and its powered by a generally low-power system device. If vendor’s information attached the specifications are not complete, reviewers cannot conclude whether this requirement should exempt or not. It will be inclusive of this missing information, and will be explained by testing laboratory or the original manufacturer about the product specifications and standards for the provision of instructions).
(3) It shall submit the full report issued by the testing laboratory, rather than the content of excerpts of the report. (The full report should include specifications, methods, and results of the original record book)
(4) If the product for in vitro diagnostic medical devices (IVD), you can refer to IEC 61326-1: 2005 (Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: General requirements) and IEC 61326-2-6: 2005 (Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment). If manufacturers using the criteria above to illustrate the electromagnetic compatibility of the products (EMC), they must submit a complete report of the test included: product name (including models), test pattern (such as PC-link data transmission function), test time, test sites, reference standards and other information. The electromagnetic compatibility (EMC) standard (IEC 61326-1: 2005, IEC 61326-2-6: 2005) references the contents of electromagnetic interference (EMI) and electromagnetic susceptibility (EMS) standards. The report must contain all references standard test results.
(5) Electromagnetic Interference (EMI) standard reference test:
CISPR 11: Industrial, scientific and medical (ISM) radio-frequency equipment - Electromagnetic disturbance characteristics
IEC 61000-3-2: Harmonic current emissions
IEC 61000-3-3: Voltage changes, voltage fluctuations and flicker in public low-voltage supply systems
(6) Electromagnetic Susceptibility (EMS) standard reference test:
IEC 61000-4-2: Electrostatic discharge immunity test (ESD)
IEC 61000-4-3: Radiated, radio-frequency, electromagnetic field immunity test (RS)
IEC 61000-4-4: Electrical fast transient / burst immunity test
IEC 61000-4-5: Surge immunity test
IEC 61000-4-6: Conducted RF
IEC 61000-4-8: Rated power frequency magnetic field (PMF)
IEC 61000-4-11: Voltage dip, Short interruptions
Q：We received the official documents that TFDA sent for medical devices inspection and registration documents to notify us that we can receive certification. But our company for the revised TFDA approved content (such as name, fake orders and labels, etc.) have different views, to how to deal with?
A：
(1) Name section：
TFDA is accordance with the guidelines for registration of medical devices of article 37 to check the name of medical devices. If the name listed on the manufactures’ application does not meet the regulations above, TFDA will inform the vendor originally. Subject to drastic changes, it will obtain the consent of application providers first and hope to communicate can be achieved consensus on both sides before ratify. If you still have any opinion about the product name that TFDA approval for after receiving the notification and approval licensing herbs, please contact the contractor personnel to discuss the verdict and then go through licensing procedures.
(2) Label artwork and Information for Use (IFU) content：
When application providers are doubt of labels and IFU for modified content after TFDA revised (like the word that is not clear after changes), or have opinions (such as the translation of contents, words are not appropriate; the contents which are deleted should be retained; or you want to add more text and other circumstances), also please contact the contractor personnel to discuss confirmation.
(3) If you have any opinion about herbal content without contact and check the licensing procedures with the contractor who confirmed the license, the issuing officer will check only the official label and the contents of IFU are consistent and complete or not. In the case of the data is inconsistent or incomplete, you can not issue a permit and tag set of the IFU.
For your rights and timeliness, please notify the receipt of licensing documents, and immediately read the document attachment (label Imitation single approved herbal) whether the contents are faithful. If you have any comments on the content of the case, please immediately connect with contractors (name and telephone contacts are listed in the top of the right corner of licensing notice) to determine the content and then make a formal instruction sheet and order the time to get the license.
Q：An application for transfer registration for an extension before the expiration of the effective period caused more than three months after the original when I ask if the license expires within six months to re-apply for registration. What information should I submit?
A：Based on "Guidelines for Registration of Medical Devices", the following documents shall be attached when applying for extension of the validity
period of a medical device permit license:
1. A medical device import (manufacture) permit license validity period extension
application form approved by the special municipality, county and city competent
health authority of the pharmaceutical company's locality.
2. Original copy of original permit license.
3. Original copies of manufacturing and sales approval documents from country of
origin.
4. Original copy of the foreign original manufacturer's continued authorization certificate.
5. Documents verifying that the manufacturing plant complies with current good
manufacturing practice for medical devices. These documents may be waived, however, when, in accordance with the Regulations Governing Management of Medical Devices, the product item does not require current good manufacturing practice for medical devices.
6. The original IFU approved this one single component [original or photocopy]
7. New single-label issued two copies IFU
8. Affidavit
Q：Whether the license can be mailed delivery?
A：Currently only accept mailed licensing remote areas, such as Taichung, Kaohsiung; Taipei area in person to the TFDA licensing in order to quickly complete the licensing of operating procedures. <Mailed licensing considerations>:
a. Licensing original document and approved herbal Please also return.
b. Please write on the envelope bag "Miss Yang closed" and filling "licensing" words!
c. Do not need to submit the returned envelope and postage.
Q：Where’s the “form for seal” on official document?
A：In the space provided below documents; cover printed on the original application used by the company and the person in charge to seal.
Q：Can pay fees by check when I receive the license?
A：You can use immediate check to pay and mark "Taiwan Food and Drug Administration." on the addressee.
Q：What are the ways for case of application for additional documents?
A：
[1] Applying for cases where information is not complete, but by posting notice when Undertaker additional documents case, manufacturers should get ready within the period of notification in accordance with the TFDA for additional documents to the information bureau or apply for an extension for additional documents a month (for once limit).
[2] The deadline for additional documents not yet in place, if the manufacturer has additional documents on file who will deemed to have additional documents cases. (I.E even if additional documents deadline has not yet arrived, manufacturers have to send the information to fill Board, TFDA will depend correction data path for a review of nuclear barge, no notice of correction data.)
[3] Where a failure to schedule additional documents nor … apply for an extension for additional documents or apply for an extension after 2 pieces yet to fill up the sender, according to TFDA will review existing data path for nuclear barge.
[4] Allowing the registration of manufacturers’ nuclear complex, may after receiving the documents within four months, get ready to be corrected data and the TFDA back pieces.
Q：What is the sterilization validation report? What’s additional documents should pay attention?
A：Medical devices common to ethylene oxide (EO) and radiation (Gamma Ray) sterilization method, two kinds of sterilization effects were indeed have ISO11135 and ISO11137 standards can reference. TFDA requirements outlined sterilization validation reports are as follows:
1. It should be carried out in accordance with.
2. It should contain instructions sterilization method applies to and consistent with the intended application products.
3. It should describe the set Sterility assurance level [SAL] value.
4. It should explain the results (such as biological indicators or biological load test results) how to verify this sterilization method validated sterilization carried achievable value of the original set of SAL.
5. It should be recent (up to 2-3 years) performed.
Q：TFDA for additional documents often appear " Certificate of Analysis" on the document, what does it mean?
A：Certificate of Analysis (Certificate of Analysis) is the test report. TFDA’s requirements include the results of the book - based on test sample name, batch number, test methods, acceptance range, the test results, the results of the determination, signature and testers test dates and other projects.
Q：TFDA mentioned “Functional tests” in the informed me up pieces of content, this is what kind of test it?
A：[1] Definition explanation: To completely understand the answer to this question before, we must first understand the medical devices. Medical devices in order to reach some kinds of medical purposes, such as the use of scientific principles, design tools made by man. For example, after the human eardrum temperature and core body temperature (core temperature) is similar, so the scanner to detect where the heat, the conversion can be measured body temperature, so the design of the "infrared ear thermometer" to measure the temperature of such a tool. But in the tool design is completed, before actually used, the manufacturer must confirm this tool is safe and effective (i.e., design verification Design Verification), confirm the validity of the test product pan-called "functional test." Because medical equipment is developed and designed by the manufacturer, so the clever design is often the most well-known manufacturer, so verify that the product manufacturer should bear the responsibility. The above example infrared ear thermometer, the most important function of the amount should be correct (Accurate, not the 38.5 ℃ measured 39 ℃) and precision (Precise, very little variation between individual measurements), so the function test should include verification of this two specifications; another factory as claimed ear thermometer with a fever alerts (such as measuring the temperature exceeds 38.5 ℃ will get a warning sound), impact shock and other functions must also be verified. Simply put, functional test that all claims for the product, including the purpose and specifications for validation testing.
[2] Practice Review: Due to a wide range of medical equipment, not necessarily functional test each product has national standards (such as our national standard CNS) or international standards (such as ISO, EN, etc.) can refer to, and the criteria listed in intent specifications, reference methods for voluntary non-mandatory, even if the same product will have different specifications and claims, it would not be able to complete a single standard specification of functional test of a single product, the practical examiners will first consult whether the products are related to national or international standards, and if so, manufacturers of functional test methods and acceptance specifications [or qualified range] whether the reference standard, or another method set specifications; if the product will not be any reference standards, examiners depending on the principle of product use and overall considerations, or by reference to examine the experience of similar products already approved the audit firms functional testing and product claims purposes are consistent specifications, test methods and acceptance range is reasonable and so on.
Q：I want to prove to the European Union and the United States listed relief preclinical testing and other information. How does TFDA determine the effectiveness of these two documents? What matters should pay attention to?
A：
[1] Scope: According to former medical equipment inspection and registration guidelines for the review of the first 15, 17, belongs to the second level of medical equipment was approved for sale attached documents and the EU Member States, the United States mandate issued by the official or substitute products in clinical testing and factory quality control test data. So first thing to note is that this simplified method is applicable only in the "second grade" product, and can only substitute "before the product is clinically tested and factory quality control test" data; If it is a third grade products (such as the common of IOL, coronary dilatation catheter) is not applicable to this requirement. Another part of the products containing animal tissue, "Animal sources of raw materials job description file" to be attached to a technical data, nor to the European Union and the United States listed proof instead.
[2] US-listed documents may be accepted in the form of two kinds: 1 United States Food and Drug Administration (FDA) issued a "Certificate to Foreign Government": the principle of selling proved to be listed in the same note, the only difference is that if when the purpose of this document is only for relief before the product quality control in clinical testing and factory inspection data (usually on behalf of non-product manufacturing plant in the United States), you can not through overseas units visa. 2 print the information from the FDA website (510 [k] Database) [See the following sample URL Links 1]: the need to pay attention to a web page or a summary (limited by the subscript text pages that can be directly connected to the frame line), and whether states: a, complete product name, type, size. b, manufacturer's name and address (not the actual manufacturer's name and address information Applicant if the site is listed, then the document can not be listed as an American proof) more important information must be stated on the page or abstract, as listed prove to be for official documents, it shall explain to the original description of the letter. Under the standard line from the summary direct hyperlinks Summary (please turn yourself) [3] EU listing documents in a form acceptable: 1 by the EU Member States, the official (s national health authority) issued the Certificate to foreign government (or Certificate the same principle should pay attention to when selling to prove listed, except that the purposes of this document, if for only the first relief product quality control in clinical testing and factory inspection data: of free sale, Free sale certificate ... etc.) (usually represent the product of non-manufacturing plant in the country), you can not through overseas units visa. Also according to the official website of Department of State data (see the following related website links 2), count 27 EU Member States, the need to pay attention to some European countries (such as Switzerland, Liechtenstein) non-EU Member States. 2 documents listed by the EU competent authority (Notified body) issue of: the need for the original (Original), shall contain the manufacturer's name, address, product name, type, size, and was listed in the European Union (can be freely sold , may be marketed or synonyms of the narrative). The EU should pay attention to the competent authority is limited to the EU official website (see the following related links 3) can be found in institutions have reviewed medical equipment (9342EEC Medical devices) on the eligibility and proof listed Notified body listed the name and address must be the site on information found in full compliance. 3. EC Certificate: published the full content (including product name, type, size, manufacturer's name, address and be listed in the EU [market, free sale or similar words) of the EC certificate. It should be noted the following matters: a, EC certificate is not published in the word factory (Manufacturer), and to Issue to ... said, should be simultaneously accompanied by a photocopy of manufacturer ISO 13485 certificate will serve both the manufacturer name and address to check whether the match. b, because many EU competent authority of medical equipment management path, the relevant regulations are subject to change, based on 6 May 1998, the TFDA "medical equipment inspection to review the principles discussed" resolution of the meeting, listing issued by the competent authority of the European Union evidence or letter, regardless of the basis on which instruction, as long as the manufacturer's name, address, and product name, model number and other relevant information contained in the application are consistent with the intended and stated to be listed [market, free sale, or similar words] in the EU can be accepted. Conversely, if the seizure of EC certificates can be listed in the EU is not stated, it will not be accepted. c, EC certificate is not published in the product name, model and specifications, list only the product range (Scope, such as Intravascular catheter, IV administration set), you must attach the original letter issued by the competent authority within the product scope description Product details Name , models and specifications. If the Notified body Product Name Model Specification Department will compile a list of Notified body as an appendix letter, then the attachment shall be issued for each page signed and sealed letter together with the description or indemnity to win the title stamped Jifeng nail treatment, etc., accessories and instructions to make sure the letter belongs to the same document. The above mentioned three documents attached neither to the original self-explanatory statement issued instead.
Link 1: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=17350
Link 2: http://www.mofa.gov.tw/webapp/ct.asp?xItem=272&ctnode=1131&mp=1
Link 3: http://ec.europa.eu/enterprise/newapproach/nando/index.cfm?fuseaction=directive.main
Q：What is the Free-Sale Certificate (FSC)?
A：[1] Definition: selling prove that documents issued by the medical equipment manufacturing capacity of the country's highest health authorities, the content stated manufacturer's name and address, the name of medical equipment, specifications, manufacturing and potential trafficking situation in their own country live . This copies of supporting documents for inspection and registration enter medical equipment essential case information. Governments for this file has the following name: Certificate to foreign government, Certificate of free sale, Free sale certificate and so on. The actual file format can refer to this site the second and third grade and selling medical equipment identification to prove registration page references in the announcement and the European Union listed prove paradigm. [2] Contract Manufacturing: If the input to entrust the manufacture of medical devices, and not in the country entrusted with the manufacturer listed on the home country to a commission issued proof of freedom of trafficking and two trustees factory manufacturing country issued proof instead. Illustration, B product by an American company commissioned a production factory located in Japan, if B products have been approved for sale in Japan, then submit proof of Japan's highest selling health authorities (Ministry of Health) issued, if the product is not in Japan B market, manufacturers need to submit proof of Japan's top health authorities issued (ie content is only stated the manufacturer name, address, medical equipment names, specifications, manufacturing situations, does not contain "approved in their listing"), and the United States the highest health authorities (food and Drug Administration that FDA) issued proof of freedom of trafficking (content stated manufacturer's name and address, the name of medical equipment, specifications and can be listed on the country). [3] Note: selling proven manufacturing proved freedom trafficking prove mentioned above, must be limited to less than two years of the effective date of issue and shall be subject to our overseas units (such as embassies and consulates, representative offices, etc. , mainland China and selling certified visa units Straits Exchange Foundation) visa. Such as non-English documents issued (such as Spanish, Japanese, Portuguese, etc.), should also be accompanied Chinese or English translation, and the translation should be visa. [4] using a photocopy of the file: sometimes prove a selling may be published on a number of products, vendors can check the original case was first attached to the application, instead of the other cases to photocopy documents, but it should be noted that the original should be placed in the specified file which docket number in order to verify the audit staff.
Q：How to make an appeal if I want to send documents? Whether it should be subject to payment?
A：
[1] Please register to receive the documents are not allowed within four months after the missing data together with the back pieces Gather information and medical equipment inspection and registration submittal form (because the case appeal of the original application case number and the number of different cases , so the need to re-fill) to the TFDA proposed appeal no need to use another payment.
[2] Information has been affixed seals back pieces, do not unpack, or otherwise made appeal this application will be re-examined, manufacturers need to be responsible for whether the information is complete.
Q：Can the multi-commodity apply by different drug manufacturers?
A：According to the TFDA 25 December 1995, the TFDA Pharmaceutical word letter by letter No. 0950349434 show: Get the interests of the license for the protection of the original drug manufacturers, and confirmed the rights and obligations of the drug responsible for product safety, handling domestic same different commodity inspection and registration of medical equipment products to apply the same principle of drug dealers, such as different drug manufacturers apply a different name for the same product license of the medical equipment held by his family druggist examination registration, subject to the original manufacturer and the original holders licensed drug manufacturers agreed to authorize, and shall be limited to contract manufacturing relationship between drug dealers and the factory.
Q：What are the restrictions and conditions for applying a multi-commodity case? And what information should be prepared?
A：
(1) Intends to apply for inspection and registration of medical devices must be fully consistent with the licensing of medical equipment has been made, that in addition to a different name, other information such as the imitation of a single label published content, product specifications and models ... and so must be the same.
(2) A multi-commodity case to apply the required information, please refer to "medical equipment inspection and registration guidelines for Article XVIII (domestic medical equipment), 19 (input medical equipment)," the relevant provisions attached materials.
1. One copy each of the original and copy of the medical device registration and market approval application form.
2. Three copies each affixed or stapled to the label attachment form of the Chinese instructions, manual, packaging, and labels.
3. Photocopy of the permit license of the manufacturer of the medical device affixed or stapled to the license attachment form.
4. Affidavit (A).
5. Two copies each of pre-clinical trial and testing and original manufacturer quality control test specifications and methods, original test records, and test results report.
6. Two copies each of relevant documents concerning product structure, materials, specifications, functions, uses, and drawings, etc. However, in the case of instruments, operating manuals and service handbooks covering the items in this Subparagraph may be submitted instead.
7. Documents verifying that the domestic manufacturing plant complies with current good manufacturing practice for medical devices. 2. Enter the medical equipment:
Q：When will the clinical trial program book contact lenses submitted for review?
A：Clinical trials of contact lenses line inspection plan shall be registered with the co-submittal, or in the case of notice of the inspection board filled up pieces of the period.
Q：Why should I have attached proof of selling in my case? Should I also like to re-examine the contractor personnel ?
A：Common to prove the absence of selling are:
[1] Attached file is not original (Original), and in color photocopying, scanning the original color after printing, or through the visa photocopy instead. Original
[2] Attached a photocopy of proof has not been specified and selling original application in which case, or did not provide the documents within the docket number, or allowed to apply for registration of the case has been closed (so that all information has been return the application provider), or a photocopy of the document is incomplete, did not submit visa pages and so on.
[3] Issued by the production of non-manufacturing countries, "the highest health authority." Mainland China as the highest health authority as "the State Food and Drug Administration," vendors submit documents issued by the Guangdong Provincial Health units that do not meet the requirements.
[4] Manufacturer name and address is incorrect, and quality system certification letter recognition login [QSD], the original instruction sheet, product labels and other information published inconsistent, or contained only Legal manufacturer published without the actual manufacturer (Production site ), or specify the manufacturer (i.e.: Manufacturer, Manufactured by xxxxx) but only states other content (such as Name of the responsible for the placing on the market, Marketed by xxxx incorporation) and other circumstances.
[5] Does not specify the product name and model specifications; and original instruction sheet, the product label marked inconsistencies; there is leakage, Calligraphists mistake; only typical product or generic name (such as blood pressure), but have not stated specifications (Model, such as aS-157); or generic name of the product only states (for example: Guide wire, disposable acupuncture needles) and order No. (Reorder Number, Catalog Number), but have not stated the full product name models (such as ZIP wire Hydrophilic Guide wire) or specifications (example: radius 0.16-1.45mm, length 13-100mm) and so on.
[6] Does not specify a production system in the country have freedom of trafficking (for example: can be placed on the French market, can be marketed without restriction within Germany and other words).
[7] Our overseas units without a visa.
[8] Has been more than two years validity period (starting by selling prove date of issue).
Q：Should contact lens case carry out to clinical trials of application for the process?
A：Registration and inspection co submittals, and audits, if the contents of the product technical information and complete inspection reports and displays product safety is acceptable, then issued a document granting begin clinical trials (clinical study plan allowed for future reference), until two hospitals the completion of clinical trials, drug dealers and then get ready to apply for a type of two copies of each report submitted for review, audit notification to licensing by the originator. [※ In addition to the clinical trial reports, other documents still need to be filled up within the notice period pieces, otherwise will first closed]
Q：What are the contents of the contact lens clinical trials program and clinical trial reports?
A：Please refer to the TFDA published 18 September 1984 the TFDA drug Zi No. 84061200 announcement.
Q：How to determine whether a product is a hyaluronic acid implant new medical material?
A：New medical equipment is a new principles, new structures, new materials, or a combination of new materials manufacturing, its safety or effectiveness of health care have not been medically proven by medical equipment (ie, the TFDA has not approved similar product) or other central competent health authority review finds those who are new medical equipment. Hyaluronic acid implant products, in principle, should TFDA has approved similar products to compare, for example as follows: Materials - sources of raw materials, additives or binding agents, average molecular weight and molecular weight distribution, particle size, etc.; performance - Use (sik into the site, depth and implantation method), claiming performance and so on.
※ Currently hyaluronic acid implant products, whether new medical material, due to a high-risk medical devices, are required to submit the relevant academic theory and research reports and data, clinical trial report, tabled TFDA medical devices advisory committee.
Q：What kind of files that meet the group's sources of raw materials of animal and sheep proof and materials management job description of the requirements?
A：Raw material control job description, is made by the manufacturer of the plant and animal material handler Control Manager can fully display shows unaffected pathogen contamination of raw materials, as well as the process of viral inactivation, sterilization and other procedures. Cattle and sheep tissues of animal origin of raw materials to prove [certificate of origin], are made by the manufacturer of animal raw material suppliers, should show that the animal belongs to the field of non-infected areas range COA announcement. ※ other non-animal raw sheep belong to organizations should be made to prove the source of raw materials and raw materials control job description for reference.
Q：Are there any general instruction sheet label precautions?
A：[1] instruction sheet: generally refers to catalog Catalog, Instruction Manual Instruction for use, operation manual Operation manual, etc., provided by the manufacturer, says claims that the product uses, precautions, model specifications, drawings and so on.[2] Product Tags: name should be included (in Chinese-made by name, enter the product other than text-based), manufacturing lot number, manufacturer name and address, the name and address of the drug dealers (input Chinese products have made another label), such as health sets, tampons, sterilization and implantable products should be labeled (+ effective date of manufacture period) or (shelf life). [3] Chinese imitation of a single draft: checking the registration application should be making Chinese imitation of a single manuscript reviewer for nuclear review. Chinese imitation of a single manuscript main intention is to allow users to understand and review the products and provide important information to reveal the range of products and the application of the case (which products, what accessories, specifications why), is not the role of advertising and promotion, and should not be published exaggerated or advertising wording. Content foreign states product name, license number, product description, product use indications, warnings, precautions, contraindications, side effects, model specifications, modes of supply (whether sterilized product, whether non-pyrogenic, etc., as is the use of before sterilization or reusable products, should be added to the proposed list cleaning, disinfection, sterilization), the manufacturer's name and address drug. As for the input product, Chinese imitation of the original single artwork should be based on full and accurate translation of the contents of a single set of imitation. [4] Note: It should be noted that published the original copy of the single-label product names, specifications should be consistent with published proof selling and product-related information (such as whether sterilization, sterilization, non-pyrogenic, etc.) should be the product of the original plant technical information and test data match, and items published in the label and package insert should also match. [5] Common errors: (1) the label of origin labeling is not correct (as marked Made in USA, but the product manufacturer is not located in the U.S.). 2. "Sterile", "non-pyrogenic", "single use only" and so is not a label (such as a label marked as sterile, single-use only, but the instruction sheet published as non-sterile and reusable). 3 sterilization error (such as a label marked as imitation single EO sterilization, but the technical data and test data attached to the radiation sterilization validation report). 4 single published fake name tag, model specifications and selling prove incorrect or inconsistent. 5 Chinese imitation of a single artwork and original content to enter the product instruction sheet gap is too large, or inconsistent with the technical data content.
Q：Why do some cases that the products are approved to apply for the TFDA the like, and it still provide relevant clinical trial reports and academic literature and submit TFDA Medical Devices Advisory Committee to discuss it?
A：Because some applications products are high-risk medical devices, such as: coronary stents, carotid stents and implants…... etc. Hyaluronic acid products with a higher risk of application or product specifications and TFDA approved the like are not the same, clinical use due to safety and efficacy concerns. It should be provided in addition to pre-clinical assessment, and it shall provide the relevant clinical trial reports and academic literature. The TFDA medical Devices Advisory Committee to confirm the clinical safety and efficacy of the product was before deciding whether to issue a license.
Q：Which kind of data should be prepared for export product for registration?
A：According to Guidelines for Registration of Medical Devices Paragraph 15 Subparagraph 7 written:” Application for inspection and registration of medical devices such as lines exclusively for export purposes who may be exempt first, paragraph 5, paragraph 6, paragraph 8 through the paragraph 10 data”
Data should be prepared as follows:
(1) Examine the application for registration of medical devices, an original and a copy for each.
(2) Three copies each affixed or stapled to the label attachment form of the Chinese instructions, manual, packaging, and label.
(3) Photocopy of the permit license of the manufacturer of the medical device affixed or stapled to the license attachment form.
(4) Affidavit (甲).
(5) Documents verifying that the domestic manufacturing plant complies with current good manufacturing practice for medical devices.
Q：How should additional documents delivery? Is it available for additional documents to delivery by mail?
A：
(1) For additional documents, it shall attach:
1. Additional documents (content of document should be clearly stated application cases of the case number and product name)
2. Gathering up pieces of documents recorded (or audit table record) the missing data, sending to TFDA registered receipt of the additional documents.
(2) For those additional documents delivery by mail, get ready
1. The missing data
2. Documents one copy of the recipient
Please fill out the "To Food and Drug Administration", do not fill out the reviewer’s name.
Q：What’s the principle of medical electrical devices category and its attachment?
A：If instrument attachment for the TFDA announced the second and third level medical devices, and the case of the application of non-instrument-specific attachment by [example: ultrasound gel, general-purpose self-adhesive patch, EEG of needle electrodes, etc.], should be handled separately the inspection and registration.
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