Healthcare facilities in Malaysia would be required to notify government authorities if they employ medical devices whose registration has lapsed, under a new guidance drafted by the country’s Medical Device Authority. The use of such “orphan” devices has been a recurring issue... Read More
Medical device manufacturers could find doing business in Malaysia more costly if new registration fees currently under consideration by the country’s Medical Device Authority (MDA) are adopted. On the table are higher registration fees for all classes of medical devices, as well... Read More
Malaysia’s Medical Device Authority in October revised its requirements for the labeling of medical devices. Under the new guidelines, devices must be labeled with a Malaysian medical device registration number within six months from their date of registration. Medical devices for home... Read More
Spiraling trade tensions between the U.S. and China are injecting uncertainty into what was already a complex environment for MedTech manufacturers. Accelerating steps, some medical technology firms have already been starting to move their operations to other countries in the region. Directly... Read More
Fueled by high sugar diets, processed food, misinformation and a dearth of early intervention, the prevalence of Type 2 diabetes is a persistent public health crisis in Southeast Asia. One of every 14 people in Indonesia, Malaysia, Singapore, and Thailand has some... Read More
A growing number of Association of Southeast Asian Nations (ASEAN) member states are coming into compliance with medical device requirements they first pledged to work towards in 2015. Under the ASEAN Medical Device Directive (AMDD), the 10 ASEAN nations agreed to bring... Read More
As medical devices increasingly flood the Malaysian market, authorities are instituting new regulations that put responsibility for ensuring the safety and efficacy of the products squarely in the hands of manufacturers. The regulations make manufacturers accountable for handling complaints, responding to incidents... Read More
As demand skyrockets for healthcare in Southeast Asia, remote medical provider technologies are becoming increasingly popular. The technologies, which include app-based medical consultations and other telehealth options, allow doctors to reach more patients, especially in remote areas where access to healthcare providers... Read More
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