Staying on top of the European Medical Device Regulation in Malaysia

25 septembre 2023
ITC News

The European Medical Device Regulation (EU MDR) governs the production and distribution of medical devices in Europe.

Compliance with the regulation is mandatory for medical device manufacturers, authorized representative, importer, or distributor of medical devices in the European marketplace and vice versa.

In Malaysia, the Medical Device Authority (MDA) that is a division of the Ministry of Health Malaysia (MOH) oversees regulating medical device and its industry platers.

According to MDA, a manufacturer must retain the services of a Conformity Assessment Body (CAB) licensed by the MDA to register a medical device.

It is crucial for all companies that import and export devices to comply with EU MDR in Malaysia.

With the aim to improve compliance, the International Trade Centre (ITC) hosted a training workshop focusing on the EU MDR regulations with MDA and SMEs.

Puan Idamazura, a certified Physicist at the MDA mentioned that the training workshop she attended in 2022 enabled her to stay updated on the latest information about EU MDR. She left the training with a better understanding of ways to incorporate EU MDR into Malaysia’s requirements.

CE marking is mandatory in Malaysia on all medical devices before importing or exporting. CE marking is an indication of the legal manufacturer having assessed the device and that it meets the General Safety and performance requirements under the MDR 2017/745.

The legal manufacturer will verify the conformity with all relevant EU requirements and must state in their EU Declaration of Conformity.

According to Puan Idamazura, she is keen for more trainings from ITC to gain more information for staying on top of the EU requirements.

About the project 

The ARISE Plus Malaysia project supports inclusive and sustainable economic growth in the country through enhancing sustainable business and investment environments, improving product quality and competitiveness, as well as enhancing sustainable and internationally quality-compliant practices in the agri-food sector. 

The three-year project is funded by the European Union and is a part of its national and regional ARISE Plus projects to support greater connectivity and economic integration in ASEAN. The project is implemented in partnership with the Ministry of Investment, Trade and Industry.