REGULATORY UPDATE | REGULATION FOR ENFORCEMENT OF MEDICAL DEVICES (RESPONSIBILITY & OBLIGATION FOR ESTABLISHMENT) 2019 STARTING JULY 1, 2022

On July 1, 2022, the regulations (Responsibility & Obligation of Establishment) of 2019 Medical Devices will be fully enforced. The regulations contained in the regulation contain regulations for all companies involved in the importation, distribution and placement of medical devices in the market that must meet all the requirements stipulated in this regulation which generally regulates post-market supervision requirements, namely requirements related to handling complaints, reporting mandatory problems. reporting, field corrective action and recall of medical devices circulating in the market. A maximum fine of up to 200,000 ringgit or a maximum sentence of two years in prison, or both, may be imposed on any company found to have violated the post-market obligations outlined in these Rules.

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MDA has provided additional references in the form of related guidance materials, which have been posted and accessible through the official MDA website, mda.gov.my, to assist those concerned in meeting the requirements of this Regulation. In addition, MDA has organized and will continue to develop appropriate training programs to assist businesses in understanding and gaining deeper knowledge of the criteria outlined in the Medical Devices Regulations (Corporate Responsibilities & Obligations) 2019. The next MDA seminar will be held at KLCC on October 6, 2022. MDA would like to invite anyone who is interested in attending this seminar to better understand and learn more about the full implementation of this Regulation, especially representatives of organizations involved in the import, distribution, and placement of medical devices on the market.

To prevent enforcement action and ensure the safety and efficacy of medical devices in the state market, MDA mandates all businesses to consistently comply with the post-market criteria outlined in the Medical Devices Regulations (Incorporation Responsibilities & Obligations) 2019.