TEBC-Regulatory Affairs Department-QSD

Examples of applying “Laser surgical instrument” for medical device license in Taiwan.

1. Manufacturers of medical devices/Dealers of medical devices

• As required by Article 14, 15, 16 and 17 of 『Guidelines for Registration of Medical Devices』, submitter of product premarket review application shall provide a copy of its “Medical Device Manufacturer License” or “Medical Device Distributor License”.

• The term “Manufacturers of Medical Devices” is defined in Article 18 of PAA as a company manufacturing, assembly medical device, or distribution and export of its devices, or import of the materials used by medical devices. Local manufacturer shall apply for factory license to local industry authority and pharmaceutical manufacturer license for medical device to local health authorities.

2. Identify the classification of your medical device

• According to the medical devices classification categorized by DOH, Laser surgical instrument was classified as class II and the classification number was :
I.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology

3.Class II Medical Device License

• Premarket Review of Class II devices
• Class II premarket submissions are reviewed by TFDA. As required by Article 15 and 17 of 『 Guidelines for Registration of Medical Devices 』 , submissions shall include the following information：
1) Application form；
2) Chinese labeling, instruction for use, packaging inserts；
3) A copy of Pharmaceutical License for Medical Device Distributor；
4) Truth and Accuracy Statement；
5) For import medical device, Free Sale Certificate issued by the health authority of the country of orginal and authorization letter issued by original manufacturer are required；
6) Two copies of preclinical test, quality control procedure and test reports；
7) Two copies of product structure, material, specifications, intended use and drawings. Operation manual and maintenance manual of instrumentation which include the above-mentioned information may be provided alternatively；
8) A copy of QSD Compliance Letter；
9) Radioactive safety information, if applicable.

fsc

FSC with notarized stamp.

loa

Letter of Authorization

Simplified PMA Checklist of New Class II Medical Device in Taiwan
(Free Sale in US and EU)

Required Items	Content	Yes
A. General Information	1. Instruction for use (Product insert)
A. General Information	2. Packaging and label
B. Certificate of Manufacture and free sale by country of origin	Original (Valid 2 years). Requirement: 1.Product name, specification, manufacture name and manufacture address 2.By the highest health competent authority 3. Legalized by Taiwan embassy in country of origin
C. Power of Attorney	See template (Original and valid 1 year)
D. Free sale certificate in other region/country. (Original)	1. By USFDA
	2. By EU Member States
E. Product Information	1. Full formulation (content of all ingredients)
F. Reference data (If publication, please state the excerpt from which journal and the issued date)	1. Research report / literature / paper of application product
	2. Research report / literature / paper of application product for treatment potency with non-ethnic difference
	3. Research report / literature / paper of substantially equivalent product
	4. For the substantially equivalent product, there is no serious adverse events to be reported in US and EU.

PMA Checklist of Class II Medical Device with substantially equivalent in Taiwan

Required Items	Content	Yes
A. General Information	1. Instruction for use (Product insert)
A. General Information	2. Packaging and label
B. Certificate of Manufacture and free sale by country of origin	Original (Valid 2 years). Requirement: 1.Product name, specification, manufacture name and manufacture address 2.By the highest health competent authority 3. Legalized by Taiwan embassy in country of origin
C. Power of Attorney	See template (Original and valid 1 year)
D. Product Information	1. Full formulation (content of all ingredients)
E. Technical documents of Preclinical tests	Specification and method of preclinical test (Include raw data) XXXX Test data XXXX Test data ……
E. Technical documents of Preclinical tests	Specification and test method of finished product Test record and COA of finished product

PMA Checklist of Class II Medical Device with substantially equivalent in Taiwan
(Free sale in US and EU)

Required Items	Content	Yes
A. General Information	1. Instruction for use (Product insert)
A. General Information	2. Packaging and label
B. Certificate of Manufacture and free sale by country of origin	Original (Valid 2 years). Requirement: 1.Product name, specification, manufacture name and manufacture address 2.By the highest health competent authority 3. Legalized by Taiwan embassy in country of origin
C. Power of Attorney	See template (Original and valid 1 year)
D. Free sale certificate in other region/country. (Original)	1. By USFDA
	2. By EU Member States
E. Product Information	1. Full formulation (content of all ingredients)
E. Product Information	2. Specification and CoA

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