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
The Malaysian National Pharmaceutical Regulatory Agency (NPRA) announced that it will implement a new good pharmacovigilance (GVP) inspection program at the beginning of 2023 with a voluntary phase. These inspections ensure that manufacturers of pharmaceutical products and their affiliates conform to the... Read More
Malaysia’s MDA regulatory body, founded a decade ago, has concluded the public comments period for parties interested in submitting feedback on its new medical device guidance, MDA/GD/0009. Offering numerous examples, MDA/GD/0009 provides classifications of medical devices known as active, invasive and noninvasive,... Read More
In a much-awaited update, Malaysia’s Medical Device Authority (MDA) has launched a streamlined online registration system designed to make it simpler and more efficient for foreign manufacturers to register their medical device products to access the country’s market. The updates to... Read More
Responding to the needs of more than 61% of citizens who identify as Muslim, Malaysia is set to launch an online system to standardize the certification of medical devices that adhere to the requirements of Islamic law. Under the Islamic requirements, known... Read More
Five years after Malaysia’s Medical Device Authority (MDA) made it mandatory for foreign manufacturers to register their medical device products to access the country’s market, the authorizations are expiring, but regulators have yet to make it possible for many to be renewed.... Read More