One similar thing about the medical device registration process in Taiwan and Japan is, documentation of the Quality System must be registered to regulatory authorities before a medical device can be sold in each market. In 2021, there were major revisions made to the process of documentation of the Quality System, which foreign manufacturers and local authorized representatives should be aware of. This article will introduce those major revisions as well as major differences process of registration of QMS.
Major Update in Taiwan:
With the new Taiwanese Medical Devices Act which came into force on May 1st, 2021, now more medical devices require submission of Quality System Documentation (QSD). Before the revision, every low-risk device (Class I devices) was exempted from the submission of QSD. With the new Act, only 125 categories of medical devices are omitted from QSD. One positive aspect of the new Act is there are 510 categories of Class I devices that can go through the Essential Application Mode. Please see the links below for products exempted from QSD inspection and products which can be inspected under the Fast-Track Route.
Major Update in Japan:
The revised Japanese Quality Management System (QMS) Ordinance came into force on August 1st, 2021. This revision was made to align with ISO13485:2016, where the Japanese medical ordinance had been only complied with ISO13485:2003 until then. Additional clauses are made to Chapter 2 Basic Requirements to harmonize with the international standard, such as:
- - Article 5-2: Marketing Authorization Holders and so forth must establish QMS based on risks of function, efficacy, and safety of medical devices. (Section 4.1.2 of ISO13485:2016)
- - Article 5-6: When using software for QMS, the process of validation must be documented. (Section 4.1.6 of ISO13485:2016)
- - Article 34: When using the statistical method for validation of design and development, the method and criteria of validation must be documented. (Section 7.3.6 of ISO13485:2016)
Differences in QMS Registration in Taiwan and Japan
1. Application Route
A major difference in QMS registration process between Taiwan and Japan is Taiwan FDA prepares different application route that is suitable for different countries and devices, where Japan has only one standardized route to apply. There are:
- 1. Abbreviated Route for the U.S.
- 2. Abbreviated Route for EU countries
- 3. Abbreviated Route for Japan
- 4. Standard Application Route
- 5. Essential Route (only for designated low-risk devices)
Although there are common standard documents that have to be submitted for every route, manufacturers in U.S., EU countries, and Japan are allowed to submit their audit reports issued by their local countries to omit submission of documents that are required for the Standard Route.
2. Timing of Application
The timing of applying for the Submission of Documents of Quality System differs between Taiwan’s and Japan’s regulatory systems. In Japan, submission of Quality System Documents must be done almost at the same time as submission of medical device’s STED. For registration of Generic Devices and Improved Device, QMS must be submitted to PMDA within at least 10 days of submission of STED. On the other hand, the Taiwanese regulatory system does not allow simultaneous submission of QSD and STED. Submission of QSD is required before submitting STED in Taiwan.
3. Omitting of On-site QMS Inspection in Japan
When registering medical devices, the most thing manufacturers want to avoid when entering the Japanese market may be on-site QMS inspection. Here are some possible routes that the Japanese regulatory authority presents for manufacturers to omit on-site inspection. Please be noted that Japanese regulatory notice states reviewers must take other factors (such as complexity of manufacturing process, past recalls, etc) into consideration to decide whether a manufacturing site requires on-site inspection, therefore the following documents may remain only as supplementary documents.
List of documents that may allow manufacturers to omit on-site QMS inspection.
- 1. ISO13485 certificate and its audit report whose
- a) scope is applicable to medical devices that will be registered,
- b) Issuance date of the certificate is within three years of submission of QMS
- c) Issuer is a registered organization that is accredited by the regulatory system of Japan, the United States, EU, Australia, or Canada.
- 2. Audit reports issued within three years of submission of QMS by PMDA or Japanese registered certification bodies.
- 3. QMS Certificates and audit reports of countries where MOU is exchanged with Japan.
Outline of QMS Inspection
QMS Inspection Services at PMDA
Comparison table of the new QMS ordinance and ISO13485:2016
Comparison table of the previous QMS ordinance and ISO13485:2003
List of Class I products exempted from QSD Inspection
List of Class I products which can be inspected under Abbreviated Mode