A Comprehensive Overview of Medical Device Registration and Post-Market Surveillance in Taiwan

Regulatory Authority

Taiwan Food and Drug Administration (TFDA)

 The regulatory system for the safety and quality of food, drug, medical device, and cosmetics is critical to the public health. As these products are intimately involved in people’s daily life and health as well as medical welfare, the Department of Health had been striving to facilitate organizational reform by focusing on consumer health in terms of food and drug safety. 

The safety and quality of food, drugs, medical devices and cosmetics are integral parts to promote the high standard of the national lifestyle, health concerns and medical treatment. TFDA provides a vigorous and comprehensive management system, serving it as a criterion for the whole nation’s health issues and setting it as a point of reference or index for the public health perspective.

Information relating to food and drug safety is released to the public more swiftly, allowing consumers to enjoy quality food and drugs that are safe to use. The TFDA will work to fulfil the vision of safeguarding national health and leading the nation into a new era of food and drug management.

Link for Regulatory Authority

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

Local Regulation

Medical Devices Act

Link for Regulation

https://www.fda.gov.tw/ENG/lawContent.aspx?cid=5063&id=3352

Classification of Medical Devices

• Class I
• Class II
• Class III

• Check if your MD is manufactured domestically or imported.
  • For domestically manufactured: MD Business Permit for manufacturer is required.
  • For Imported MD: MD Business Permit for dealer is required.

Listing or Registration Requirements

1. Determination of medical device classification
2. Verification of classification
3. Application of registration
4. Preparation of registration documents and fees
5. Class I, II, III can be further classified to IVD and Non-IVD
6. Application submitted to Taiwan Food and Drug Administration
7. Review Centre (Document Review)

• Class II, III, and New medical device applications will undergo two stages of review: Administrative and Technical.
• Class I products only require an Administrative Review.

8. License Granting

Documents Required for Registration

• Application form
• Copies of Chinese labelling, instruction for use, packaging inserts.
• A copy of Pharmaceutical License for Medical Device Manufacturer/Distributor/Agent.
• Truth and Accuracy Statement.
• Free Sale Certificate issued by the health authority by the country of origin (for imported products) and authorization letter issued by manufacturer.
• Copies of preclinical test, quality control procedure and test reports.
• Copies of product structure, material, specifications, intended use and drawings.
• A copy of Quality System Documentation (QSD) / Good Manufacturing Practice (GMP) Compliance Letter, ensuring quality systems align with global GMP compliance audit guidelines.
• Literature Review (Class III IVDs and New products only).
• Clinical Investigation Reports (Class III IVDs and New products only).
• Radioactive safety information (if applicable).

License Application Instructions

1. Product Name and Application Form
2. Labelling and Instructions
3. Medical Device Business Permit
4. Certificates of Origin
5. Manufacturer Authorization
6. Quality Management System Document
7. Preclinical Testing Documentation
8. Product Documentation
9. Clinical Evidence
10. Radiation Safety Information
11. Essential Principles and Summary Technical Documentation

Registration Timeline

• Class I : 1-2 months
• Class II : 7-8 months
• Class III : 8-12 months

License Validity

5 years

Special Labelling Requirements 

Documentation and labelling to be submitted in Chinese.

Post Market Surveillance

Medical device firms and medical institutions must report any domestic serious adverse event of a medical device on the internet system designated by the central competent authority and notify the authority or its commissioned agency, legal entity, or organization,  adhering to robust pharmacovigilance protocols.

The report must include:

1. Name, address, contact method of the reporting firm or organization and name of the reporter.
2. Date of occurrence and date of finding of the serious adverse event.
3. Product name in Chinese and license number or listing number of the medical device.
4. Model or specifications and batch number of the medical device.
5. Direct supply source and flow of the medical device; if reporter is the end user organization where the adverse event occurred, there is no need to report product flow.
6. Current status of the medical device in the occurrence of serious adverse event.
7. Category and outcome of the adverse event.
8. Description of the adverse event occurrence.

It should also include:

• Region where the adverse reaction occurred, symptom, and severity level.
• Product problem.
• Factors and processes that may result in serious injury.
• Patient’s follow-up treatment.

Items that must be mentioned in PMS Plan

Medical Device Periodic Safety Report

Medical Device Safety Summary Report

Who should make this Communication?

• Manufacturer
• Authorized Representative

When to make this Communication?

Before placing a medical device into the market.

How OMC Medical can assist you with the process?

• Act as your Authorized representative

Why Choose Us?

• Working towards client satisfaction
• Cost effective solutions
• Project completion before deadline
• Quality Regulatory affairs solutions

Contact us for free consultation: sales@omcmedical.com