"Strategic approach to ASEAN Medical Device Regulatory, Key points to know when considering oversea business"

On January 14, 2022, we held the 5th Academia Clinical Development Seminar online, inviting Mr. Go Murayama, Representative Director, Qualtech Japan Consulting Corporation.
Mr. Murayama has been involved in regulatory affairs such as product registration of medical devices both in Japan and overseas.
In this seminar, he gave a lecture titled "Strategic approach to ASEAN Medical Device Regulatory, Key points to know when considering oversea business" based on his extensive experience.

First, he explained about the most important medical device regulation in ASEAN, the AMDD (ASEAN Medical Device Directive).
He said that the AMDD is a harmonized guideline established in 2015 to unify the medical device regulations of ASEAN countries, and that the framework is based on the decisions of the IMDRF* (International Medical Device Regulators Forum), so it is similar to the EU regulations such as the adoption of risk-based medical device classifications and the CSDT (Common Submission Dossier Template).
* Activities by medical device regulatory authorities around the world to promote the harmonization of international medical device regulations.

Next, he talked about the important points to be considered from the viewpoint of the three elements of regulations.
He explained that the three elements of medical device regulations are "premarket approval" for safety and efficacy of medical devices, "quality management" for process control to ensure continuous design and manufacture of effective and safe medical devices, and "post-market surveillance" on product data collection/ evaluation, and response including incident reporting to authorities.
He also said, as points to be noted, there are differences between ASEAN and Japan in terms of the applicability of medical devices in "premarket approval," there are difficulties in ensuring quality in terms of handling instruction manuals in local languages, and there are cases where test reports based on international standards other than JIS standards are required, he said.

He then explained how to proceed with the overseas development of medical devices.
He said that while the harmonization of medical device regulations is progressing worldwide, the regulations in Europe are the strictest, and therefore, it is recommended to obtain approval in Europe first and then expand to ASEAN to ensure smooth regulatory compliance.
On the other hand, due to stricter regulations under the newly applied MDR (Medical Device Regulation) in Europe, there are many cases where companies are expanding their business from ASEAN, and in some countries, the approval by Japanese authorities is a prerequisite for application, and in others, the approval by Japanese authorities allows for expedited review, he said.

Next, specific examples of "premarket approval" for custom-made medical devices and Software as Medical Devices (SaMD) were explained.
He said that custom-made medical devices can be distributed through an exemption application/ notification route other than the normal product registration route.
As for SaMD, the international standard IEC 62304 (Medical device software - Software life cycle processes) is the main regulatory requirement, and the application can proceed smoothly by meeting this requirement, he said.

Lastly, he mentioned that one of the challenges of pre-marketing approval seen in overseas expansion is the prolonged review period, and that in order to obtain approval quickly, it is important to be familiar with the latest regulatory requirements and proactively respond to regulations without being bound by precedent.

In this seminar, Mr. Murayama gave us useful information on medical device regulations in ASEAN, and the seminar ended successfully with a large number of participants and a lively question and answer session.

The next seminar will be held on Friday, February 4, 2022, with Dr. Noriatsu Kono from Pharmaceuticals and Medical Devices Agency (PMDA) on the theme of "Evaluation for Medical Devices including SaMD (Software as Medical Devices)."
We look forward to seeing you at the next meeting.

For more information about the 6th Academia Clinical Development Seminar, please click here. (information only in Japanese)