• 2025-11-21 08:14:15

The Malaysian Medical Device Authority (MDA) has issued the Medical Device (Amendment) Regulations 2025 [P.U.(A) 330], which were gazetted on 11 September 2025. This amendment revises the fee structure for registrations of Class A medical device effective on or after 1 January 2026. Stakeholders are advised to review the changes and plan their submissions accordingly to ensure timely compliance.

• 2022-08-30 03:32:59

Starting July 1, 2022, MDA fully implemented the Medical Device (Responsibility & Establishment) Regulations.

• 2021-09-29 02:05:59

Starting July 1, 2022, MDA will start to fully enforce the Medical Device (Duties and Obligations) Regulations 2019 or better known as 2019 Regulations. The regulations focus on various medical device-related establishments’ responsibilities on post-market activities.

• 2020-02-21 06:58:33

Recently, on 15th November 2019, the Malaysian Government passed the order to gazette Medical Device (Advertising) Regulations 2019 (‘Advertising Regulations’), based on the Medical Devices Act 2012.

• 2020-02-21 06:57:58

The Medical Device (Duties and Obligations of Establishments) Regulations 2019 (‘Establishments Regulations’) specifies in detail the responsibilities of establishments involved in the importation, distribution and post-market surveillance of medical devices in Malaysia.

• 2020-02-14 07:45:46

The Medical Device Authority (MDA) has issued a new Circular Letter on March 5th 2018 bearing new requirements for the licensing and medical device registration for Original Equipment Manufacturer (OEM) in Malaysia. This circular letter identifies who construes as an OEM and the reason why OEMs are not regulated under the Medical Devices Act 2012 (Act 737) till far.