This article was originally published on MedTech Intelligence. Introduction Sports medicine is the treatment of injuries or health problems related to exercise, sports, or any other health activity. Asia accounts for approximately 15 percent of the global sports medicine market, which was... Read More
The Malaysian Medical Device Authority (MDA) has updated the requirements for medical devices that are exempt from registration. The devices are the following: Demonstration models for marketing or education Models built for clinical research or performance evaluations Custom-made or special access devices... Read More
Following the example of the U.S. FDA's Orphan Drug Act established in 1983, some Asian countries have developed orphan drug legislation, such as Singapore's Orphan Drug Exemption to the Medicines Act and Japan's Orphan Drug Amendment to the Pharmaceutical Affairs Law. While... Read More
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