Medical Device Regulations of Taiwan

By Tim Lin

Time To Read 4 minutes

Market Introduction

With more than 22,000 USD per capita gross domestic product (GDP), and around 7% of its GDP spending on healthcare, with 70% imported medical device, Taiwan is a high-income country with a considerable healthcare expense. Furthermore, approximately 99% of its population is covered by governmental National Health Insurance. Along with the challenge of an aging population, in order to keep its people active and healthy, Taiwan has a high demand for medical devices and pharmaceuticals.

Medical Device Regulation Structure

The Taiwan medical device management system was reformed in 2000, and since 2005 it has been mandatory for all medical devices in the Taiwan market to be licensed. TFDA (Food and Drug Administration, Taiwan) was established in 2010 under the Department of Health (DOH) as the competent authority of food, drug, medical device and cosmetics. In 2013, the administrative level of the DOH was elevated to be the Ministry of Health and Welfare (MOHW).

In alignment with other global regulatory authorities, TFDA has adapted risk-based classifications and segmented medical products types, including general medical devices and IVDs, into 17 categories according to clinical applications. TFDA has also adapted its own good manufacturing practice (GMP) for quality systems, which is harmonized with ISO 13485. Similar to other Asian countries, a local qualified distributor must be the applicant for quality system review and product registration. As of late 2015, TFDA encourages distributors to comply with Good Distribution Practice (GDP) voluntarily.

 For foreign manufacturers, in addition to the on-site inspection and full quality system documentation (QSD) review, TFDA provides two additional modes to simplify the review process.

Quality System

Domestic manufacturers-For domestic manufacturers, the GMP approval letter must be obtained based on on-site inspection results. TFDA has designated four governmental organizations to conduct the on site inspection.
They are:

  • Metal Industries Research & Development Center (MIRDC)
  • Industrial Technology Research Institute (ITRI)
  • Electronics Testing Center (ETC)
  • Plastics Industry Development Center (PIDC)

When the company’s manufacturing sites successfully passed their GMP assessment, the manufacturer will receive a GMP approval letter valid for three years.

Foreign manufacturers-For foreign manufacturers, in addition to the on-site inspection and full quality system documentation (QSD) review, TFDA provides two additional modes to simplify the review process.

  • Simplified mode for American factories: For manufacturers located in the US and certified to ISO 13485; the applicant can provide the manufacturer’s ISO 13485 certificate, establishment inspection report (EIR) and Certificate to Foreign Government (CFG) issued by the US FDA to apply under this simplified mode.
  • Simplified mode for European Union factories: For manufactures located in the EU region (including Switzerland and Lichtenstein), that have ISO 13485 certificates issued by one of 11 TFDA recognized notified bodies, such as UL(UK), based on the current Technical Cooperation Program (TCP) II notice, applicants can provide the manufacturer’s ISO 13485 certificate, manufacturer inspection reports and free sale certificate to apply under this simplified mode.

Upon approval, the manufacturer will receive a QSD approval letter valid for three years.

Product Registration

TFDA classifies medical devices into three risk-based categories. Class I – Low risk, Class II – Moderate risk and Class III – High risk. Subject devices without predicate devices in the Taiwan market are regarded as new devices. The general requirements for devices with different risk classes are shown below.

Class Class I Class II Class III New Device
GMP/QSD Yes * Yes Yes Yes
Technical review of Product Registration Yes/No ** Yes Yes Yes
Clinical Data No No Yes *** Yes ***

 

* Since March 11, 2014, devices that are Class I, not sterile or do not have a measurement function and on the appendix II of medical device supervision, should still demonstrate compliance with the specified GMP chapter.
** Technical review of some Class I devices is still required.
*** Foreign clinical data are acceptable unless noted.

For the technical documentation package, TFDA accepts documents and testing reports written in either English or Traditional Chinese. For Class III devices, STED format is required. Electrical safety, EMC and biocompatibility testing reports should be issued by labs that are in compliance of ISO 17025 or Good Laboratory Practice (GLP). In addition, the applicant has to provide package inserts and labels written in Traditional Chinese based on the original documents, in accordance with the rules and format as specified in published documents by TFDA. Besides in-house review, TFDA has several review panels that conduct professional technical evaluations, including Center for Drug Evaluation (CDE), Center for Measurement Standards (CMS) and Medical Device Advisory Committee.

TFDA has published many product-specific pre-clinical guidance documents as references for product registration. TFDA also recognizes most international standards which are generally adapted by industries as reference for review. Instructional guidance of software validation, mobile medical application and usability engineering are in the development process.

Recent Regulatory Updates (March 2016)

  1. TFDA is promoting “Good Distribution Practice (GDP)”, and encouraging distributors to voluntarily comply. TFDA published relevant documents including instructions, checklists, and will also provide on-site supportive inspection to assist distributors with conformity.
  2. As of Nov 10, 2015, TFDA will conduct preliminary screening of technical dossier readiness against its registration checklist upon submission.
  3. TFDA has established a mechanism to help combination product (drug with device) manufacturers determine the responsible division for submission review.

What UL Global Solutions can support?

Local experts as your consultant to help you with product approval. The medical device registration rules in Taiwan are complicated and change rapidly. UL Taiwan’s local expert team consists of previous TFDA reviewer, experienced and skilled regulatory professionals who act as a consultant group to assist you to get product approval quickly.

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References:
  1. National Statistics, Directorate General of Budget, Accounting and Statistics, Executive Yuan, R.O.C (Taiwan)
  2. National Health Insurance Administration, Ministry of Health and Welfare, Executive Yuan, R.O.C (Taiwan)
  3. National Health Insurance Administration, Ministry of Health and Welfare, Executive Yuan, R.O.C (Taiwan)
  4. National Health Insurance Administration, Ministry of Health and Welfare, Executive Yuan, R.O.C (Taiwan)

 


Author

Tim Lin is Senior Technical Consultant. Mr. Lin majored in public health and medical device engineering, and has more than 10-years experience in medical device regulatory. He worked as a reviewer at Center for Drug Evaluation/Taiwan FDA for high and moderate-risk medical device and clinical trial protocol for over 6 years, and also drafted guidance for industry. He was also an invited speaker for international medical device forums to share experiences of regulatory affairs and technical documentation.