Registration of medical devices in Taiwan (TFDA)

Taiwan Medical Device Registration is managed by the Food and Drug Administration (TFDA).
First, in Taiwan, classification of general medical devices is classified into Class I, II, and III according to the FDA rating system in the United States, and is classified into 16 items below.

No.	Item name
1	Clinical chemistry and clinical toxicology
2	Hematology and pathology devices
3	Immunology and microbiology devices
4	Anesthesiology devices
5	Cardiovascular devices
6	Dental devices
7	Ear, Nose, and Throat device
8	Gastroenterology-Urology devices
9	General and Plastic Surgery devices
10	General hospital and personal use devices
11	Neurological device
12	Obstetrical and Gynecological devices
13	Ophthamlic devices
14	Orthopedic devices
15	Physical medicine devices
16	Radiology devices

 

Taiwan issues licenses only to locally based companies, foreign companies must obtain approval through importers or suppliers' subsidiaries in Taiwan.
In addition, local manufacturers in Taiwan apply for GMP (Good Manufacturing Practice) and undergo on-site quality system review, and in the case of overseas manufacturers (imports), they replace overseas manufacturers' on-site review with quality documents when they are classified into three categories.
1) European CE manufacturers and manufacturers in the United States are eligible for QSD simplification
2) General QSD targets where medical device permission is obtained from overseas countries
3) Subject to on-site inspection by overseas manufacturers if not applicable to 1) and 2)

 

Preparation documents for medical device registration are as follows.

	manufacturing	importing
Class I	1. Application for medical device registration and marketing approval 2. Copy of medical device manufacturing license 3. GMP Compliance Certification for Medical Devices (In the case of consignment manufacturing, a consultation document signed by the trustee and the consignee is required)	1. Application for medical device registration and marketing approval and Affidavit 2. Medical device sales contract license Copy of (Sales Business License) 3. QSD conformity certificate and proof document
Class II / III (STED)	1. Application for medical device registration and marketing approval and Affi-davit 2. Copy of medical device manufacturing license 3. GMP conformity certificate and proof document 4. All middle door instruction leaflet, catalog packaging, labeling, usage, product appearance photos to be attached to the packaging box 5. Preclinical ETC Test Records and Reports 6. Technical documentation 7. Theoretical research reports and data 8. clinical trial report 9. Safety information data for radiation products	1. Application for medical device registration and marketing approval and Affidavit 2. A copy of the medical device sales contract license (sales license) 3. QSD conformity certificate and proof document 4. All middle door instruction leaflet, catalog packaging, labeling, usage, product appearance photos to be attached to the packaging box 5. Original authorization letter for manufacturing and sales of the country concerned 6. Full-time examination reports and reports 7. Technical documentation (including operation manual for equipment) 8. Papers and Data 9. clinical trial report 10. Safety information data for radiation products

Please refer to the link below for detailed legislation on Taiwan's Pharmaceutical Affairs Law.

 

Pharmaceutical Affairs Act - Article Content - Laws & Regulations Database of The Republic of China (Taiwan)

 

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