Engaging the medical device industry for effective regulation

Representatives from the medical device regulators of Japan, Philippines, Malaysia, Indonesia and Thailand share on their efforts to engage effectively with the industry.

To close off day 1 of the ASEAN-Japan Dialogue on Healthcare, the medical device regulators in Japan and several ASEAN countries presented an introduction of their work and an update on the medical device regulations in their respective countries.

For background, 10 ASEAN Member States have ratified the ASEAN Medical Device Directive (AMDD), which aims to harmonise medical device regulations (such as on medical device classifications and labeling requirements) in the region.

Here is a summary of their presentations:

1.Japan

Speaker: Dr Tatsuya Kondo

Chief Executive Emeritus of the Pharmaceuticals and Medical Devices Agency (PMDA)

Summary

The PMDA summarises its three functions in the form of a ‘Safety Triangle’ – Review (Reduction in risk); Relief (Relief measures for issues caused by adverse drug reactions); and Safety (Continuous risk mitigation efforts).

In the past years, PMDA has made efforts to address the issue of ‘drug lag’ in Japan, where new drugs lagged around 4 years after initial launch to be introduced in Japan. In addition, its Asia Training Center for Pharmaceuticals and Medical Devices Regulatory Affairs holds training sessions for regulators around the world, which aim to contribute to enhancement and mutual understanding of regulations, and strengthening of cooperation in Asia and other parts of the world. In FY 2017, 235 regulators from 27 countries participated in the training sessions.

2. Philippines

Speaker: Ms. Maria Cecilia C. Matienzo

Director, Center for Device Regulation, Radiation Health, and Research, Food and Drug Administration, Philippines

Summary

A balance is needed between effective regulation and ensuring public access to medical devices. Ms Matienzo emphasises that communication is key, and the FDA engages the industry through a series of consultative meetings when developing guidance documents. The final draft is posted on the FDA website, and shared at public forums, for the public and other stakeholders to comment.

After implementation, platforms such as informal forums, pilot tests and seminars also keep the communication channels open with industry players. In post market surveillance (monitoring the industry’s compliance to the new regulations), the FDA monitors the sale of medical devices across all media platforms, and advisories are issued or enforcement activities are carried out for products that violate the regulations.

3.Malaysia

Speakers: Dr. Salbiah binti Yaakop
Director of Policy, Code and Standard Division, Medical Device Authority (MDA), Malaysia

Ms. Wan Nurhalimah
Assistant Director of Corporate Communications Unit, MDA, Malaysia

Summary

In terms of industry engagement, MDA’s Medical Device – Industry Collaborative Committee meetings bring the medical device industry players and MDA together to discuss compliance matters, collaboration programmes, international engagement training and conferences.

In addition, MDA provides consultation services to assist the medical device industry to understand and comply with its requirements. It has several online communication channels, such as a feedback management system and online training sessions, to ensure effective communication with industry and public.

4.Indonesia

Speaker: Mr Lupi Trilaksono

Deputy Director of Local Medical Devices and Household Health Products, Ministry of Health, Indonesia

Summary

Currently, all registration procedures for medical devices in Indonesia are conducted online. Companies that require consultation services may visit MOH’s office in Indonesia. Foreign medical device companies exploring investments in Indonesia can also approach the Indonesia Association of Medical Device Manufacturers (Aspaki).

During the COVID-19 pandemic, Indonesia relaxed certain medical device regulations to ensure sufficient access to critical supplies. For example, emergency use approval was granted for devices required in handling of COVID-19, and the authorities simplified and prioritised COVID-19-related product license and distribution/manufacturing license applications. With safe distancing measures in place in Indonesia, pre-market and post-market control and audits are being conducted virtually or remotely.

5.Thailand

Speaker: Dr. Sirinmas Katchamart
Pharmacist, Senior Professional Level from Medical Devices Control Division, Food and Drug Administration, Thailand

Summary

Thailand has just ratified the AMDD in January 2021. It has issued new medical device regulations aligned with the AMDD, with a new classification system for devices from Class 1 (Low risk) to Class 4 (High risk).

Following the amendment of the regulations, there will be a transition period to shift to the new regulatory regime. Companies can choose whether to submit the full Common Submission Dossier Template (CSDT, or the common template under AMDD) or partial documents (and follow up with the full CSDT within three years).

Dr. Katchamart shared that there are plans to translate the regulations to English and uploaded on the FDA website next month.

To join the ASEAN-Japan Dialogue on Healthcare sessions, please click here.

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