As of July 1, 2022, the regulations concerning the Responsibility and Obligation of Establishments under the Medical Devices Regulations of 2019 will be fully enforced. These regulations apply to all companies involved in the importation, distribution, and placement of medical devices in the market. Companies must comply with the requirements outlined in this regulation, which primarily focuses on post-market supervision. This includes handling complaints, reporting mandatory problems, conducting field corrective actions, and executing recalls of medical devices in circulation.

Violations of the post-market obligations specified in these regulations may result in penalties of up to 200,000 ringgit, a maximum sentence of two years in prison, or both.

To assist stakeholders in meeting these requirements, the Medical Device Authority (MDA) has made additional guidance materials available on its official website, mda.gov.my. The MDA has also organized and will continue to develop training programs aimed at helping businesses understand the criteria established in the Medical Devices Regulations (Corporate Responsibilities & Obligations) 2019. The next MDA seminar is scheduled for October 6, 2022, at KLCC, and all interested parties, particularly representatives of organizations involved in the import, distribution, and placement of medical devices, are invited to attend.

To ensure compliance and promote the safety and efficacy of medical devices in the market, the MDA mandates that all businesses consistently adhere to the post-market criteria outlined in the Medical Devices Regulations (Responsibility & Obligation for Establishments) 2019.