Malaysia’s Medical Device Authority issued new mandatory medical device adverse event reporting criteria. If a medical device fails, is found to be not as effective as it claims, or has inadequate labelling or instructions, a report must be submitted within 30 days... Read More
Introduction In 2016, Malaysia’s economy expanded 5% and the population was at 30 million. The country also has the third highest GDP per capita adjusted for purchasing power pairty (PPP) in ASEAN at $27,000, behind only Singapore and Brunei (International Monetary Fund,... Read More
There are several steps to consider when entering the Asian medical device market. This presentation covers 10 essential steps to help grow your business in Asia. Case studies will be used to demonstrate key points. To view these presentation slides, please click... Read More
The Malaysian Health Ministry is planning on launching the Malaysian Health Transformation Initiative. The goal of these efforts is to converge public and private healthcare systems together in order to provide a sustainable, affordable, and high quality system to Malaysians. In past... Read More
This article was also published on Medtech Intelligence. Asia is the largest and most populous continent in the world. With a population greater than 4.4 billion (or about two-thirds of the world’s population), there are tremendous medtech opportunities in the region. Nowadays,... Read More
Studies have shown that Asians are at a higher risk of developing type II diabetes than Europeans. As Asia is continuing to develop, lifestyle diseases such as diabetes, hypertension, and high cholesterol are on the rise. About 70% of diabetes patients live... Read More
Malaysia Medical Device Authority product classification steps (click to download full size image). Read more about why it is important to classify your product before registering your product as a device in Malaysia. For more information about our medical device or pharmaceutical registration... Read More
Multiple countries in the APAC region have been experiencing outbreaks of preventable diseases in 2016. The number of Singapore’s measles cases doubled in the first half of 2016 compared to the same time period in 2015, while Malaysia’s tripled from 2015 to... Read More
While the US and EU have been using health economics outcomes for drugs and devices for a number of years, Asia is behind in this area. Much of this is caused by the lack of standardized systems, regulations, and resources needed to... Read More
The Medical Device Authority Ministry of Health in Malaysia recently released draft guidelines for “drug-medical” and “medical-drug” combination products. Previously, Malaysia lacked standards for combination product registration and regulatory requirement. Despite these draft guidelines, registering combination products in Malaysia will still take... Read More