With the full enforcement of the Medical Device (Responsibility & Establishment) Regulations 2019, all parties involved in the importation, distribution, and placement of medical devices on the market are required to comply with all post-market control requirements, including complaint handling, mandatory problem reporting, field corrective action, and recall for medical devices on the market.
Any establishment that violates the post-market requirements outlined in this rule may face enforcement action. That is, a maximum fine of up to RM 200,000 or a jail term of up to two (2) years, or both.
In addition, the MDA will organize appropriate training programs to assist the establishment in understanding and obtaining more information on the requirements outlined in the set regulation. The next MDA seminar will be held at KLCC (Kuala Lumpur City Centre) on October 6, 2022. This seminar is open to anyone who is interested, particularly those involved in the importation, distribution, and placement of medical devices in the market.
To avoid any enforcement action and to ensure the safety and effectiveness of medical devices in the country's market, the MDA advises all establishments to always comply with the post-marketing requirements set out in the Medical Device (Responsibility & Establishment) Regulations 2019.