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How to introduce your medical devices to Taiwan?

In Taiwan, medical devices require approval from the Taiwan Food and Drug Administration (TFDA) prior to commercialization, and the legal framework of the regulatory system is based on the Medical Device Act. The regulatory system in Taiwan is closely aligned with the United States (US) regulatory system in terms of product classification and evaluation. For most devices, a Quality System Document (QSD) certification is also required.

Related resources:

Taiwan Food and Drug Administration

Medical Device Act                   

Regulations Governing Issuance of Medical Device License, Listing and Annual Declaration

STEP 1 | Appoint a In-country Regulatory Representative

A foreign manufacturer must appoint an in-country representative to apply for registration in Taiwan. This in-country representative is in possession of the medical device registration license and the QSD Certificate and also handles post-market vigilance.

STEP 2 | Medical Device Classification

The product categories and regulations in Taiwan are adapted from the US FDA classification system. Medical devices are also classified into Class I, Class II and Class III based on their risk level. Class II and Class III devices must have the approval of their home country before they can be registered in Taiwan. For some specific low-risk Class I devices, there is a simplified listing process. Medical device companies can make inquiries to the central authority regarding the classification of medical devices or other related matters.

Related resources:

Application for the classification of Medical Devices

Announcement Regarding Items Not Regulated as Medical Devices

Class I devices that will be eligible for the listing process

STEP 3 | Quality System Requirements

Quality system Documentation (QSD) must be submitted by foreign manufacturers before device registration, with the exception of certain listed non-sterile, non-measuring Class I devices. ISO 13485 certification is necessary because Taiwan's regulations are aligned with it. There is a simplified QSD review process for eligible manufacturers in the US, EU and Japan, including Puerto Rico, Guam, Switzerland and Liechtenstein.

Related resources:

Medical Device Quality Management System Regulations

Regulations Governing the Inspection of the Medical Device Quality Management System and the Issuance of the Manufacturing license

Certain non-sterile Class I devices are exempt from QSD registration

STEP 4 | Required documents

Documentation required for registration of Class I medical devices includes, but is not limited to, labeling and instructions for use and proof of submission of QSD application (if applicable). Class II and Class III medical devices require the preparation of a registration application and dossier. Required documentation includes, but is not limited to, copies of labeling and instructions for use and preclinical test results.

Related resources:

TFDA’s Instructions of the License Application

STEP 5 | Application and Reviewing

For Class I devices, the review process takes about 3 months. As for Class II and Class III, the process may take 8-12 months. For devices containing new materials or technologies for the Taiwan market (i.e., "New Devices"), a Medical Device Committee Review is required and the approval time will be extended.

STEP 6 | Approval

Upon approval, TFDA will issue a hard copy of the Medical Device Product License, which is valid for five years. Documents for renewal must be submitted six months before expiration.

STEP 7 | Importation and Distribution

Since medical devices can only be imported by certificate holders or authorized companies, your license holder must submit an authorization application to TFDA on your behalf to import your product. Once the distributor receives the letter of approval from TFDA, you can begin selling your device in Taiwan. Please note that only GDP-certified importers/distributors may import, store and distribute certain high-risk medical devices.

Related resources:

Regulations Governing Border Inspection and Examination of Imported Medical Devices

Regulations of Medical Device Good Distribution Practice

Regulations for the Inspection of the Good Distribution Practice for Medical Devices and Licensing of Distribution License

STEP 8 | NHIA Reimbursement

If needed, we can assist you to apply a reimbursement code or self-pay code from National Health Insurance Administration (NHIA) for your consumable products.

STEP 9 | Post Market Surveillance

As part of its post-market monitoring and adverse event reporting requirement, TFDA requires medical device manufacturers to collect safety information regarding the use of their devices both in Taiwan and abroad. Medical device license holders are also required to notify the TFDA of serious adverse events. Recalls of defective medical devices (or medical devices manufactured without a license) are also mandatory. New medical devices and certain high-risk medical devices may be subject to a surveillance period during which Periodic Safety Update Reports (PSUR) must be submitted.

Related resources:

Regulations for Management of Medical Device Safety Surveillance

Regulations for Reporting Serious Adverse Events of Medical Devices

Regulations for Medical Device Recalls

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