Malaysia: Full Enforcement Announcement of Medical Device Regulations (Responsibility & Establishment) 2019
MDA would like to inform that the Medical Device (Responsibility & Establishment) Regulations 2019 will be fully enforced, effective July 1, 2022. With the full enforcement of these rules, it means that all parties involved in the importation, distribution, and placement of medical devices in the market are required to comply with all the post-market control requirements including requirement for complaint handling, reporting of mandatory problem, field corrective action, and recall for medical devices on the market.
Any establishment who violated the post-market requirements set out in this rule may be subjected to enforcement action including maximum fine of up to two hundred-thousand-ringgit (RM 200,000), or a jail term of up to two (2) years, or both.
The MDA has provided further references in the form of relevant guidance documents that can be accessed through the MDA’s official portal at mda.gov.my.
The MDA will also organize appropriate training programs to assist the establishment in understanding and obtaining more information on the requirements set out in the set regulation. The nearest MDA seminar will be held on October 6, 2022, at KLCC. Every party who is interested, especially the establishment involved in the importation, distribution, and placement of medical devices in the market, is invited to participate in this seminar.
The MDA advises all establishment to always comply with the post-marketing requirements set out in the Medical Device (Responsibility & Establishment) Regulations 2019 to avoid any enforcement action and to ensure the safety and effectiveness of medical devices in the country’s market.
If you have any queries regarding this announcement or our services for medical device registration and representation in Malaysia, please get in touch.