Easing the path to market for medical devices used in emergencies, Malaysia’s Medical Device Authority (MDA) in April exempted certain devices from registration requirements. The changes, included in a first edition guidance document, “Notification on Medical Devices for Special Access” apply to... Read More
This article was originally featured on Medtech Intelligence. As Asia’s prostate cancer burden grows, so do opportunities for Western medical device companies with products to diagnose and treat the disease. Leading Western medical device firms are moving into markets across the Asian... Read More
In November 2018, Malaysia’s Medical Device Authority released the Third Edition of its Guidance Documents on Requirements for Medical Device Labeling. Major changes include: Medical devices for home use must be labeled in Bahasa Malaysia. Other types of medical devices shall be... Read More
With rates of hepatitis B infection higher in Asia than anywhere else on the globe, deaths from liver cancer are an overwhelmingly Asian phenomenon. Almost 80 percent of cases and deaths from liver cancer occur on the Asian continent, according to the... Read More
Spending on healthcare is expected to balloon by more than 70% over the next two decades in Malaysia, Indonesia, the Philippines, Singapore, Thailand and Vietnam, according to a report presented at the World Economic Forum. Total healthcare spending in the six nations... Read More
Seeking to quell confusion over which of its regulatory agencies has purview over medical devices that are used in combination with pharmaceuticals, Malaysia’s Medical Device Administration (MDA) has released guidelines for classifying such products. The combination products, known as Medical Device Drug... Read More
The Association of Southeast Asian Nations (ASEAN), which is comprised of the countries Indonesia, Malaysia, Philippines, Singapore, Thailand, Vietnam, Brunei, Laos, Myanmar, and Cambodia, was established in 1967 to promote peace and stability in the region, facilitate collaboration and mutual assistance among the... Read More
A Malaysian law requiring companies that manufacture or market medical devices in the country to register with the government goes into full effect this month, six years after it was first passed. The 2012 law was designed to bring Malaysia, which imports... Read More
This article was originally published on MedTech Intelligence. Driven largely by hepatitis in its various forms, liver disease has long been a fixture of life in China and Southeast Asia. Over the past three decades, public health programs in the region have... Read More
Malaysia’s healthcare sector is set to grow at an average rate of 8.4 percent over the next six years, having almost doubled since 2012 to reach an expected 11.3 billion ringgit ($2.9 billion) in 2018, consultancy firm Frost & Sullivan reported in... Read More