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Registration of medical device in Taiwan

Background

 

Taiwan is not huge in term of geography however one of the important market in Asia for most manufacturer. The market size was 2.7 billion $ in 2021 with 3% grow rate. Overseas should not ignore Taiwan market with moderate registration demand, awareness of heath and an increased aging population.

 

There is predicate cost and time at site of authority. The language of submission dossier is in English. Taiwan registration has some Asian characters in term of structure of authority, legislative, however from the art of classification of products and quality management they are very western. For example for some of notified body in EU, Taiwan is a critical part at MDSAP inspection. So better to have a compliant Taiwanese QM and prepare technical documentation for product registration with same emphasis.

1.What is legislative of medical device in Taiwan

 

The responsible authority for food, drug, medical device and cosmetics is Taiwan Food and Drug Administration (TFDA) which is an important organisation of ministry of health and welfare. With the mission of "Safe and Effective Medicine, Safe and Healthy Food" and the vision of "Guardian of Food and Drug Safety Trusted by the Whole People, Creating a Safe Food and Drug Consumption Environment", the Department has established a sound food and drug safety management system and fulfilled the commitment of the Ministry of Health and Welfare to promote the health and well-being of the whole people. Under TFDA is “center for drug evaluation” similar like Center for Devices and Radiological Health in US which makes technical dossier evaluation and regulatory consultation.

 

The important regulation is medical device act under the Presidential Decree in 2021. There are 85 articles and 9 chapters.

 

Useful link:

https://www.fda.gov.tw/ENG/index.aspx

https://www.cde.org.tw/eng

https://www.ncc.gov.tw/english/index.aspx

 

2. Dose manufacturer need a Local representative?

 

To register medical device, it is essential to have a local representative. In some other countries it called Chinese agent, US agent, marketing authorisation holder in Japan or authorised representative in EU.

 

The local representative should have business license and medical device business permit. The role of local representative is universal the registration of dossier, communication with authority and oversee post market activities.

 

3.Time and cost to register product in Taiwan

 

There are initial-, change registration and renewal in Taiwan. It is clear regulated regarding time and cost in term of these registrations (class I, II and III) as well QSD, determination of classification and innovative medical device. The time below in table is calendar day from the review of authority.

Fig 2_Time and cost_1-min.PNG
Fig 2_Time and cost_2-min.PNG
Cost of register medical device in Taiwan

4.Classification of medical device

 

There are 3 classifications for medical device in Taiwan: I (low risk), II (medium risk) and III (high risk). The classification can be matched with identification. The classification alphabetic character (A-P) plus 4 numbers is corresponding relevant classification. So there are 16 categories (classification number) according to their function, intended use, operating instructions, and working principle, depending on the applicable medical specialty:

  • Clinical chemistry and clinical toxicology devices

  • Hematology, pathology, and genetics devices

  • Immunology and microbiology devices

  • Anesthesiology devices

  • Cardiovascular devices

  • Dental devices

  • Ear, nose, and throat devices

  • Gastroenterology and urology devices

  • General, plastic surgery, and dermatology devices

  • General hospital and personal use devices

  • Neurological devices

  • Obstetrical and gynecological devices

  • Ophthalmic devices

  • Orthopedic devices

  • Physical medicine devices

  • Radiology devices

If the classification of medical device is difficult or impossible to define, an application for determination for product classification can be made.

5.Which documents are to submit to apply for class II and III medical device?

 

The prerequisite to mark medical device in Taiwan is home country approval. For registration you have to submit free sales certificate or any other kind of original approval evidence.

The following documents are needed at technical documentation:

  • Free sales certificate

  • Authorisation letter

  • Test specification and methods

  • Clinical evidence

  • Radiation safety information

  • Essential requirement

  • Label, IFU and packaging

  • Original licence

  • Quality management certificate

  • Product structures, materials, specifications, functions, intended uses and drawings

  • Test specifications and methods of preclinical testing and quality control

 

6.Make sure not to forget (Local) testing (e.g. NCC for active product)

 

The most demanding testing is for products with wireless function. You`d better to have wireless components with new valid certificate under “national communication commission” (NCC). In this case you have to transfer the authorisation of medical device using wireless technology to local distributor. Otherwise you have to test the single wireless module and hardware. It is similar to FCC in US/Canada, RED in EU, MIC in Japan and KC in Korea. There are different accredited laboratory in Taiwan which make wireless tests. Plan the test independently to product registration so save for market entry in Taiwan.

 

7.English dossier, however Labelling in traditional Chinese

 

According to the “Medical Devices Act” Article 32, medical device firms that manufacture or import medical devices shall attach labels in traditional Chinese to the smallest packaging unit for sale and provide Chinese instructions before engaging in the sale, wholesale, and retail.

The following particulars shall be indicated on the labels, instructions, or packaging of medical devices:

1. Product name.

2. License number or listing number.

3. Effectiveness, intended use, or indications.

4. Date of manufacture and shelf-life or expiration date.

5. Model number, specifications, or major components.

6. Warnings, cautions, use limitations, or expected and foreseeable side effects.

7. Name and address of the license holder or the person who completed the listing.

8. Name and address of the manufacturer.

9. Lot number or serial number.

10. Other particulars that shall be indicated as announced by the central competent authority.

 

Instruction for use must be in traditional Chinese. The contents may include product description, indications/intended use (or purpose and function), warnings or precautions, side effects or complications, contraindications, model number and specifications. If the product involves accessories, the model number, quantity, and specification of accessories shall also be prepared. Contraindications, warnings, side effects and precautions must be accounted in detail and accurately, printed in rubic or boldtype font, or highlighted with a red frame.

 

8.Quality System Documentation

Quality System Documentation (QSD) is actually a premarket and continuous post market activity. The quality management certificate at product registration is not sufficient. Every 3 years you have to update quality management in tem of remote paper inspection.

 

There are simplified documents for TW-QSD if legal manufacturer has recent inspection audit in EU (only for recognised notified body), Japan or US. Otherwise the legal manufacturers have to submit following documents:

  • Application form

  • Home country certificate

  • Quality system management as ISO 13485

  • Quality manual

  • Quality system procedural documents

  • Plant layout diagram

  • Layout of production area

  • Main manufacturing equipment and main testing equipment

  • Manufacturing process diagram

 

The certificate of QSD is 3 years. It is recommended to submit the next renewal six months prior to expiration of certificate.

Besides remote inspection every 3 years by Taiwan authority, the legal manufactures has to show compliant process and records at annual MDSAP inspection often.

9.Change assessment (design control)

 

After initial registration there is a critical post market assessment which is often underestimated: design change. Under significant change, you have to start a change registration before marking the new changed products in Taiwan.

The change guidance in Taiwan is quite straightforward without complex deciding trees. You just need to observe the typical significant changes as

  • Chinese or English product name

  • IFU, labelling and packaging

  • Increase or decrease of variants

  • Enhanced performance

  • manufacturers name

  • Production address

  • New local representative

Contact us for your international registration of medical device and IVD. We speak yor language and local language at interessted market. We understand medical device from design, development to final compliance approval.

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