A new Medical Device Act was announced by the Taiwan Ministry of Health and welfare in November 2020 and has taken effect on 1 May 2021. These changes will affect the foreign manufacturers and local distributors. Enforcement Rules of the Medical Device Act (ERMDA) Taiwan FDA (TDFA) has implemented the change to shift all relevant medical device (MD) clauses from ‘Enforcement Rules of the Pharmaceutical Affairs Act (ERPA)’ to ERMDA. Starting from 1st May 2021, manufacturers must take reference with ERMDA pertaining to all medical devices. Below are new updates in ERMDA, previously not in ERPA:
For advertising medical devices, it specifies conditions for advertisement/non-advertisement and requirements. The new rule will reduce complicated communications between health professionals.
A clear definition of ‘manufacturing’ as “using physical or chemical methods to transform materials, substances or components into medical devices. This process does not necessarily involve completion of packaging, labelling and sterilization”.
Sub-contractors’ mandatory acquiring of GMP licenses before processing with production steps.
Addition of new reporting requirements for the license holder for any risk or suspected risks relating to a registered device.
Product Registration New regulations are being issued for Medical Device License, Listing and Annual Declaration. New measures required for product registration are:
“Similar device” clarification
“listable” for certain low-risk Class I products rather than “registerable”
Abridged pathway for Class II devices updated.
If the product is on the list in Appendix 3, it may be eligible for the abridges pathway regardless of its overseas approval status.
Products with short term licenses without long-term safety and efficacy data but meets one for the following criteria:
Products used for life-threatening or serious disability diseases with no alternative available.
Meets pressing domestic public health or medical needs; Or
Significant clinical benefits from innovative or novel devices to improve or assist medical diagnosis and treatment.
Periodic safety surveillance or post-market research programs are required from these short-term licenses. Quality System
Medical Device Quality Management System regulations Medical devices are separated from the current “Pharmaceutical Good Manufacturing Practice Regulations” under the new regulations. Hence, QMS requirements will be applied in ISO 13485:2016.
Inspection of the Medical Device Quality Management System and the Issuance of the Manufacturing license regulations Guidance level documents now includes detailed requirements under the new regulations. The agency review process for a QSD application has some updates:
QSD renewal application has extension of validity period. If the TFDA assessment extends pass the expiration date of the original QSD certification, this would provide a safety margin for the application.
TFDA are authorized to randomly examine product sample for its assessment.
Good Distribution Practice Medical Device Good Distribution Practice (GDP) regulations Local medical device dealers of certain high-risk devices are required by the new Medical Device Act to establish an effective GDP system. These would provide detailed requirements on distribution control, including record keeping, management responsibilities, resources, client feedback, purchase process, traceability, product protection, monitoring and measuring equipment control, analysis and improvements.
Inspection of the Good Distribution Practice for Medical Devices and Licensing of the Distribution License regulations
Local distributors with products listed on the TFDA mandatory list are required to obtain a GDP license. Currently there are 45 categories on the list -44 are class II and only one category is class III.
The validity of a GDP license is for three years. Each renewal application can extend the validity for another three-year period. TFDA can conduct unannounced audits at those GDP sites, hence local representatives/distributors must work towards obtaining a GDP license after 1st May 2021, for any medical devices stated in the list. Given a two-year transitional period, local representatives/distributors must get a license before 1st May 2023.
It is advisable to set up a GDP system of products that are currently not in the list as TFDA may be updating the list periodically.
Post-market Surveillance
Reporting Serious Adverse Events of Medical Devices regulations
New regulations are based on the current “Regulations for Reporting Adverse Reactions of Medicaments”. Minimum effects on the internal post-market surveillance procedures are anticipated due to minor updates of “Serious adverse events” definition.
Medical Device Recall regulations New regulations are based on the current “Regulations for medicament recall”, and few changes will need insertion in the commercial operator’s QMS:
Definitions of recalls are updated.
“Packaging, IFU or Labelling” is no longer included for a level 3 recall conditions. The regulations permit a continuous supply of products with a valid product registration license.
It is noted that the above regulations are still in a draft and there are little anticipation changes made before the final implementation. Do ensure that your systems are updated to manage this transition and the continuous compliance with the local regulations.
Mandatory Technical Personnel appointment for Medical Device manufacturers and dealers
“Administrative Measures for Medical Equipment Technicians” that was recently published outlines the Technical Personnel requirements and qualifications for medical devices that manufacturers and dealers needs. A three-year transition period is given for this requirement.
Source:
Contact us at info@arqon.com for more info