To register devices in Malaysia, you must make a dossier submission according to the required items in the Medical Device Act of 2012, and the specific instructions outlined on the Malaysia Medical Device Authority (MDA) website. Starting May 1, the MDA changed... Read More
In the past, Malaysia’s medical device authority (MDA) issued only paper physical Medical Device Registration Certificates. Starting May 2, the MDA started issuing registration certificates electronically. During the transition period from May 2 to December 31 this year, the MDA will issue... Read More
Historically, there have been more drug clinical trials in the West than in Asia. However, recently this has changed, and there are more than 8,000 clinical trials in Asia now and less than 8,000 clinical trials in the West. Please note that... Read More
In November 2018, Malaysia’s Medical Device Authority (MDA) issued the third edition of their Change Notification for Registered Medical Devices. On November 2 this year, the MDA updated this notification. The new updated version includes two main new sections – Clause 5.8... Read More
In early October, Malaysia’s Medical Device Authority (MDA), has released a guidance document for companies in the medical device space. An Establishment License delineates the local requirements for manufacturing, exporting, and importing of devices in Malaysia. The guidance document provides definitions for... Read More
In August, the Malay Medical Device Authority (MDA) issued a guidance document outlining the Association of Southeast Asian Nations (ASEAN) harmonized list of medical devices. This list includes over 250 devices and also classifies the devices (A, B, C, and D) in... Read More
Most medical devices require registration in Malaysia. Registrations are good for 5 years, and many companies are now facing re-registration. In June, the Malay Medical Device Authority released the new re-registration guidelines. Re-registration applications must be submitted via the MeDC@St application system.... Read More
On April 1, Malaysia’s Medical Device Authorities (MDA) issued a guidance document further classifying devices into 3 categories – 1. Non-invasive medical devices, 2. Invasive medical devices, and 3. Active medical devices. In addition to these categories, a number of new rules... Read More
Digital healthcare trends are flourishing in Asia due to its aging population, shortage of healthcare personnel, increasing consumer demand, and technological innovation. According to statistics from Graphical Research, the digital health market in Asia Pacific is expected to grow by 33% from 2020... Read More