Taiwan update: Classification scheme, final fee schedule, post-market surveillance measures
Taiwan's Medical Devices Act, which replaces the country's former regulatory framework for medical devices, went into effect on May 1. But while the law is now operative, not all of the new developments relating to it have been immediately clear. The Taiwan Food and Drug Administration (TFDA) has continued to release a rapid series of announcements and guidance documents to provide clarity to manufacturers and other stakeholders, and Emergo by UL has accordingly prepared a third roundup of newly provided information about the regulations. For more background, please see the initial announcement of the law and our first and second roundups.
TFDA publishes new classification scheme for medical devices
The TFDA published the Administrative Measures for Medical Equipment Classification and Grading (links in Chinese), which establishes the list of device codes, product categories, and corresponding risk classification under the Medical Devices Act. The risk classification scheme remains structurally equivalent to the previous scheme, but it introduces 68 new device codes, removes two device codes (E.0007 and F.3530), and adjusts the classification of two codes (N.3045 and N.3070).
Article 6 of the document states that devices that do not fit into the existing device codes will be classified as Class III devices, unless there is a similar device to base the classification on, or unless an inquiry with the TFDA has been made to determine the appropriate classification. The inquiry process is described in Article 5.
The classification scheme provided here is effective as of May 1. However, Article 7 of the document identifies a later implementation date of July 1, 2022 for three new device codes (A.3652, C.3372, and C.3950). The document does not specify a transition period for the other new and amended codes.
Finalized fee schedule for device applications
The schedule of fees has been finalized, with a few changes when compared with the draft version detailed in the previous roundup. Of note are the following differences:
Novel device registration for imported devices with no predicate in Taiwan or overseas carries a fee of 250,000 NTD. The previously noted fee of 130,000 NTD still applies to devices featuring a new principle, structure, material, or performance, or having no predicate in Taiwan.
The Class II device registration fee has been lowered from 60,000 NTD to 58,000.
A Good Distribution Practice (GDP) application and inspection fee of 30,000 NTD has been added to the schedule.
The TFDA also published the following announcements:
Post-market surveillance measures
Measures for Reporting Serious Adverse Events of Medical Equipment, outlining the procedures and timelines for reporting serious adverse events. A Notification Form is provided as an Annex to the document.
Administrative Measures for the Safety Surveillance of Medical Equipment, establishing the required submission of safety monitoring plans and reports for designated high-risk devices. Templates are provided as Annexes to the document and are also available on the TFDA website.
Regulations for Medical Device Recalls, outlining the notification procedures and timelines for product recalls. Levell III recalls will now require the submission of a Recall Plan, whereas previously only Levels I and II required that submission.
Preparation of technical documents and instructions for use
Guidelines on Essential Principles and Summary Technical Documents for the Safety and Efficacy of Medical Devices, intended to guide manufacturers in preparing their Essential Principles (EP) checklist and technical documentation in summary technical documentation (STED) format.
Principles of Writing Chinese IFUs for Medical Devices.
Principles of Writing Chinese IFUs for In Vitro Diagnostic Medical Devices.
Miscellaneous TFDA announcements regarding the Medical Devices Act
Measures for Border Inspection and Examination of Imported Medical Equipment, establishing the border inspection procedures for imported medical devices in accordance with Article 52 of the Medical Devices Act. Devices subject to the inspection are condoms and general, surgical, and N95 masks. The examination methods and standards, as well as a schedule of fees, are provided as attachments to the announcement.
An announcement identifying 8 low-risk devices which may be exempt from submission of pre-clinical testing documents, provided the manufacturer has previously registered a similar device in Taiwan. An Affidavit of Conformity of these devices to the established pre-clinical testing standards (provided as attachments to the announcement) must be submitted.
Clinical Trials of Medical Devices Without Significant Risks, establishing the criteria for medical device clinical trials to be exempt from notification to the TFDA.
Medical Device License Issuance, Listing, and Annual Declaration Standards, which establishes the new procedures and requirements for medical device listings, registrations, renewals, and post-approval modifications. Submission requirements by class are detailed in the document's Annexes. Notably, the new listing procedure for designated Class I devices is outlined in Chapter 5, Article 20-23 of the document. Certain Class III IVDs will also now require submission of samples for inspection during registration.
More regulatory resources for medical devices and IVDs in Taiwan from Emergo by UL:
Taiwan medical device registration and approval consulting
Taiwan Agent in-country representation
Taiwan medical device regulatory strategy report
Taiwan medical device vigilance reporting
Video: Introduction to Taiwan's medical device approval process
Timothy Herr
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