Apr 28, 2021

Following up on our earlier post providing details on Taiwan’s new medical device regulations, the following is a summary of noteworthy details that have subsequently become available. These are compiled from various announcements and guidance documents (all links in Chinese) published by the Taiwan Food and Drug Administration (TFDA). Unless otherwise specified, these changes will go into effect with the law on May 1. One of the key documents included in this roundup is a draft fee schedule.

New listing process for designated Class I medical devices

  • A list of Class I devices which may be registered through the listing process outlined in Article 25 of the Medical Devices Act, effective as of October 1, 2021. The list contains 68 device codes, significantly fewer than were included in the draft list released in November 2020. The listing process features less burdensome requirements for manufacturers than those involved in full registration with the TFDA.
  • A draft announcement regarding the automatic listing of currently registered Class I devices that will be eligible for the listing process. The consultation opened on April 20 and will remain open for a total of 60 days.

Good Distribution Practice (GDP) requirements for high-risk devices

  • Guidelines for Good Transportation and Distribution of Medical Devices. This document provides guidance on implementing Good Distribution Practice (GDP), as required for importers and distributors (identified as "dealers") of certain high-risk medical devices, in accordance with Article 24 of the Medical Devices Act. The guidelines specify documentation, facilities, human resources, and traceability requirements, among others. The list of devices subject to GDP licensing was published in a previous TFDA announcement.
  • A resource hub on the TFDA website providing a considerable amount of information on GDP requirements, including a list of frequently asked questions (FAQs) and specifics on the license application and renewal process.

Quality management system (QMS) certification requirements

  • Medical Device Quality Management System (QMS) Guidelines, intended for local and overseas manufacturers as guidance on QMS certification. This certification is required for all devices under the Medical Devices Act, except for some low-risk, non-sterile devices. A draft list of these exempt devices was issued in a previous announcement. Annex I of the new guidance includes a different list of devices which, provided they are non-sterile, are eligible for the Abbreviated Application route for QMS Certification.
  • A series of announcements explaining that medical device manufacturers located in the US, EU (plus Switzerland and Liechtenstein), and Japan will still be eligible for a simplified QMS application.

Other communications from TFDA regarding Medical Devices Act implementation

  • An updated and slightly renamed version of Principles of Compiling Chinese IFUs for Home-Use Medical Devices, along with three example templates for manufacturers to use as they prepare instructions for use (IFUs) for such devices. The three product types covered by the templates are soft contact lenses, electronic blood pressure monitors, and infrared lamps.
  • A TFDA announcement featuring a list of 12 devices that require additional warnings and precautions on their labeling.
  • Guidelines for Contract Manufacturing of Medical Devices, specifying the submission requirements and notification procedures regarding contract manufacturing, as referred to in Article 23 of the Medical Devices Act.
  • Measures for the Establishment and Management of Medical Equipment Source and Flow Data, which specifies requirements regarding the recording and reporting of supply and distribution data, in accordance with Article 19 of the Medical Devices Act. These requirements will apply to registration holders and dealers of certain designated Class II and III implantable devices. They will cover over 200 devices (a draft list can be found here), and monthly reporting of these records will be required for the following devices: cardiac pulse generator (E.3610), silicone breast implants (I.3540), and transvaginal surgical mesh (L.5980). There is no required format for how the documentation should be prepared. A short compilation of frequently asked questions has also been published.
  • Measures for Approved Manufacturing and Importing of Certain Medical Equipment Projects, which specifies exceptional circumstances for which a manufacturing or import approval may be granted, in accordance with Article 35 of the Medical Devices Act.
  • Implementing Rules of the Medical Devices Act, which provides additional clarification on some subsections of the Act, including advertising, business licensing, labelling, and adverse event reporting.
  • An announcement specifying that advertisements for contact lenses, except for daily wear disposable lenses, may only be published in medical publications, events, and other communication tools targeted exclusively to health professionals.

Draft fee schedule includes new and increased regulatory fees

The TFDA published a draft fee schedule for a full range of regulatory applications, to take effect on May 1. There are some notable fee increases, including for device registrations and QMS registrations, and the new schedule also includes fees for the new listing process for designated Class I devices.

The following table provides a comparison between current fees and those about to be implemented:

Application type

Current fee (NTD)

New fee (NTD)

Device registrations

Novel device registration

65,000

130,000

Class III registration

38,000

100,000

Class II registration

25,000

60,000

Class I registration

10,000

15,000

License renewal

6,000

8,000

Amendments, renewal, and license issuance

Add intended uses

30,000

40,000

Add models/Changes in specifications

25,000

35,000

Changes in specifications not impacting product safety or efficacy

15,000

25,000

License transfer/Manufacturer address change

15,000

25,000

Other changes

8,000

10,000

License issuance

1,500

1,500

Online device registration (for designated Class I devices)*

Online device registration

-

10,000

Online registration annual renewal

-

2,000

Online registration amendments

-

8,000

QMS (quality management system; formerly known as QSD) registration

QMS registration/Certificate renewal

38,000

60,000

Add product categories/Address change

38,000

60,000

QMS certificate transfer/Other changes

8,000

10,000

QMS registration/renewal/modification with on-site audit

600,000

600,000

Other applications

Medical device judgement

2,000

3,500

Importation authorization

2,500

4,000

Medical device advertisement (new application)

5,400

10,000

Medical device advertisement (renewal)

2,000

5,000

*New application type

Further regulatory resources for medical devices and IVDs in Taiwan from Emergo by UL:

Author

  • Timothy Herr

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