Malaysia’s Ministry of Health (MOH) has recently announced that it will factor real-world evidence (RWE) in its decision-making for the inclusion of drugs into its national formulary – the “Blue Book.” This change signals a shift toward moving beyond reliance on clinical trial data alone and toward... Read More
Japan’s Ministry of Health, Labor, and Welfare (MHLW) and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) celebrated the tenth anniversary of their Memorandum of Cooperation with Korea’s Ministry of Food and Drug Safety (MFDS). For the last ten years, the agencies have... Read More
On July 30, 2025, the Medical Device Authority of Malaysia (MDA) launched the Malaysia–China Medical Device Regulatory Reliance Program (Pilot Phase I) with an end date of September 30, 2025. The program uses the Global Harmonization Working Party (GHWP) structure to form... Read More
Introduction Quality, safety, and efficacy are of the utmost importance for drug products. A vital part in achieving this is having a Drug Master File (DMF). A DMF is a confidential submission to a health authority to provide detailed information about the... Read More
In the Asia-Pacific (APAC) region, regulators are taking important steps to shape the future of artificial intelligence (AI) in medical technology. With that progress comes recognition of the usefulness and transformative potential of AI, and the necessity for new levels of oversight.... Read More
India’s DCGI, on January 6 revised the device classification of 4 main device categories. These categories include 186 interventional radiology devices, 114 radiotherapy devices, 75 Oncology devices, and 803 Class A Non-Sterile and Non-Measuring devices. Please remember that India classifies medical devices... Read More
Artificial intelligence is transforming healthcare in Asia: improving the quality of care, facilitating operational efficiency, and increasing patient access. For example, the National University Health System (NUHS) in Singapore uses AI to accurately predict how long patients will stay in the hospital,... Read More
Malaysia’s drug market is growing at about 6% per year, but not easy to succeed in. First of all, registering foreign drugs in Malaysia takes a long time and is fairly demanding on the regulatory front. Second, generally, the existing IP protection... Read More
Recently, The Asia Pacific Medical Technology Association (APACMed) released their position paper titled “Risk-based Change Management for Registered Medical Devices.” As noted in this paper, some Asian countries utilize risk-based methods for device changes, while others require change submissions no matter what... Read More
Device registration in Malaysia is aided by prior approval in the EU/US. An EC Certificate (EU CE Marking) or EC Declaration of Conformity is recognized by the Malaysia Medical Device Authority (MDA) as an approved type for the conformity assessment process for... Read More