Fasten your seatbelt! Taiwan Medical Device Act and new regulations come into force
In November 2020, we published an article on the draft Medical Device Act (“new Act”) announced by the Taiwan Ministry of Health and Welfare. The new Act is now confirmed to come into force on 1 May 2021, along with all its supporting Regulations. This is a monumental change for the medical device regulations in Taiwan, and as such, Taiwan FDA (TFDA) has been running a series of workshops to bring the industry up to speed with the new and revised requirements. We had a chance to participate in these forums and share our insights on the key changes that may impact foreign manufacturers and their local representatives/distributors:
A number of new regulations will take effect along with the new Act on 1 May 2021. We have summarised the updates of the Medical Device Act in our previous blog, so let’s take a look at its supporting regulations.
Enforcement Rules of the Medical Devices Act (ERMDA)
The TFDA promulgated the ERMDA to re-locate all medical device (MD) related clauses in the current “Enforcement Rules of the Pharmaceutical Affairs Act (ERPA)”- that is, all of the MD clauses will be removed from the ERPA and placed in the ERMDA. Manufacturers for medical devices will need to refer to ERMDA from 1st May 2021. The ERMDA has some key updates which are currently not available in the ERPA:
- Clarifies conditions considered as advertisement / non-advertisement and requirements specifically for advertising medical devices. For example, materials for educating/training medical personnel on a specific medical device without the provision of contact details of the seller will not be regarded as advertising materials (taking into account the context under which the material is presented). The current advertising rules prohibit educational materials for specific medical devices – this often results in complicated communications with health professionals, the new Rules will facilitate that process.
- Clearly defines “manufacturing” – the new Rules defines “manufacturing” as “using physical or chemical methods to transform materials, substances or components into medical devices; the process does not necessarily involve completion of packaging, labelling and sterilization.”
- This now clearly mandates the acquirement of GMP licenses by the subcontractors engaged in such production steps. However, this change is unlikely to impact imported devices since most foreign legal manufacturers rely on QSD approvals rather than GMP licenses.
- Adds new reporting requirements for the license holder for any risk or suspected risks relating to a registered device. From now on, in addition to reporting serious adverse events, any risk/suspected risk will become reportable within 7 days of acknowledgement by the license holder.
New Regulations Governing Issuance of Medical Device License, Listing and Annual Declaration are being issued. The documentation required for product registration is similar to the current requirements, but there are new measures in place such as:
- Clarification of “similar device” – devices with the same intended purposes and different technical features may be accepted as “predicates” if the different features do not influence product safety and efficacy.
- Certain low-risk Class I products will become “listable” rather than “registerable” – the TFDA will require certain Class I devices to be listed via the online application platform. Paper-based submission will be abolished for these products. The listed devices also require an annual declaration to confirm the product information in the TFDA system” is still current and correct.
- Updated abridged pathway for Class II devices – the current regulations exempt Class II devices with both European and US approvals from submission of the pre-clinical data.
- Within the new Regulations, a device may be eligible for the abridged pathway if the product is on the list in Appendix 3 regardless of its overseas approval status. As the current list only consists of 34 products, the change will close the door for many imported Class II devices that are currently eligible for the abridged pathway.
- Short-term licenses for products that do not have long-term safety and efficacy data but meets one of the following criteria:
- products for use on life-threatening or serious disability diseases and no alternative is available;
- meet the urgent domestic public health or medical needs; or
- innovative or novel devices which have significant clinical benefits for improving or assisting medical diagnosis and treatment.
These short-term licenses are however subject to periodic safety surveillance or post-market research programs.
Regulations Governing Medical Device Quality Management System
The new Regulations separates medical devices from the current “Pharmaceutical Good Manufacturing Practice Regulations”. Therefore, the requirements for QMS will move from ISO13485:2003 to the now more commonly applied ISO13485:2016.
Regulations Governing the Inspection of the Medical Device Quality Management System and the Issuance of the Manufacturing license
The new Regulations now incorporates detailed requirements that were previously included in guidance level documents. There also some updates in the agency review process for a QSD application, for example:
- Extensions of the validity period of a QSD renewal application if TFDA assessment extends beyond the expiration date of the original QSD certificate (provided that the renewal is filed within the stipulated timeframe and the delay is not attributed to the manufacturer). This provides a safety margin should a QSD certificate that come to expiry is linked to an application.
- Authorisations for TFDA to randomly examine product samples as part of the assessment.
Good Distribution Practice
Regulations of Medical Device Good Distribution Practice (GDP)
The new Medical Device Act requires local medical device dealers (e.g., distributors) of certain high-risk devices to establish an effective GDP system. These supporting Regulations provides 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.
Regulations for the Inspection of the Good Distribution Practice for Medical Devices and Licensing of Distribution License
Local distributors will need to acquire a GDP license if their products are on the TFDA mandatory list. There are currently 45 product categories on the list- 44 are Class III, and only one category is Class II.
A GDP license is valid for three years and can be extended for another three-year period during each renewal application. Additionally, TFDA can conduct unannounced audits at those GDP sites – if any of your products are on the list, make sure your local representative/distributor is compliant with the GDP and is working towards obtaining a GDP license after 1 May 2021. There is a two-year transition period so they must have a license before 1 May 2023.
As TFDA may update the list periodically, it is advisable (and good practice) to still set up a GDP system even if the product is not currently on the list.
Regulations for Reporting Serious Adverse Events of Medical Devices
The new Regulations is based on the current “Regulations for Reporting Severe Adverse Reactions of Medicaments”. Only minor updates to the definition of “serious adverse events” are anticipated to affect internal post-market surveillance procedures.
Regulations for Medical Device Recall
The new Regulations is formulated based on the current “Regulations for medicament recall”, a few changes will need inclusion in the commercial operators’ QMS:
- Updates to the definitions of recalls
- Level 3 recall conditions also no longer include changes of “packaging, IFU or labelling” (“labelling”). Under the current legislation, a labelling change approved by the TGA would trigger a recall of products in the field for examination/seal stamp by the local health authority. The new regulations allow continuous supply of products so long as the product registration license is valid.
We note that some of the above regulations are still in a draft state; however, the TFDA has ceased seeking public opinions and there is only a few days until the implementation date. We do not anticipate any significant change prior to final implementation. Make sure your systems are updated to manage this transition and ensure continued compliance with local regulations.
Our team can help to assess the impact of the change on your specific projects and organisation, and support you to navigate through this transition in the most effective way.
We tailor our services to the requirements of your business and can help you implement plans that are best suited to your projects. Contact us now to discuss your needs and how we can help. You can drop us an email [email protected] or call 1 888-271-5063 (US toll-free) ♦ +61 2 9906 2984 (Sydney)
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