• 2026-07-27 01:56:36

On June 1, 2026, the NMPA issued an announcement to further clarify the work related to registration and filing following the adjustment of the management classification category of medical device products. The announcement covers various scenarios, including initial registration, renewal registration, and change registration, and sets forth corresponding requirements for the production, distribution, and import of the products.

• 2025-07-10 10:02:10

The Malaysia Medical Device Authority (MDA) has published the latest edition of Harmonised Borderline Products in ASEAN which provides an updated classifications list for products that may fall under medical device regulations across ASEAN member states. This update helps establishments to determine their products classification (medical device or non-medical device).

• 2022-01-26 10:47:58

Recently, HSA has finalized the "Medical Devices Product Classification Guide" after concluding the discussion with stakeholders. This document aims to help the stakeholders in determining whether a product is a medical device or not.

• 2021-04-26 02:13:50

Health Sciences Authority (HSA) published “Medical Devices Product Classification Guide” draft comments. This document aims to help the stakeholders in determining whether a product is a medical device or not.

• 2020-02-13 06:02:57

It has been earlier established that Medical Device Authority (MDA) and National Pharmaceutical Regulatory Agency (NPRA) of Malaysia will start to regulate drug-medical device and medical device-drug combination products together, starting July 1st, 2019.