Responding to the needs of more than 61% of citizens who identify as Muslim, Malaysia is set to launch an online system to standardize the certification of medical devices that adhere to the requirements of Islamic law. Under the Islamic requirements, known... Read More
Five years after Malaysia’s Medical Device Authority (MDA) made it mandatory for foreign manufacturers to register their medical device products to access the country’s market, the authorizations are expiring, but regulators have yet to make it possible for many to be renewed.... Read More
Spotify: https://open.spotify.com/episode/61krNTBfW9nKHadjtOOIuT?si=zGlmcBWnTUKGYT7qXOo1XQ&dl_branch=1 Apple: https://podcasts.apple.com/us/podcast/project-medtech/id1513851432?i=1000527075358 Read More
Addressing the rising concern that some medical devices designed for use by medical professionals are being advertised and distributed on the open market, Malaysian health authorities are tightening regulations on the unauthorized sale of such devices. In a public notice published in... Read More
Advertising rights in Malaysia will be granted only for medical devices that have obtained registration permits from the country’s health regulators, according to new guidance published in April by the country’s Medical Service Authority (MSA). The guidance is designed to ensure that... Read More
The combination of a relatively low–cost workforce and increasingly reliable quality and ethical standards is turning the Asia-Pacific region into a hub for clinical trials. With pharmaceutical firms under growing pressure to provide innovative new products at reasonable prices, the region is becoming more... Read More
Seeking to clarify requirements manufacturers must follow when grouping medical devices together for the purpose of product registration, the Malaysian Medical Device Authority (MDA) in February released a new draft guidance document describing the applicable rules and procedures. According to the draft... Read More
A host of rehabilitative technology companies are entering the Asian market in force, driven by the needs of the region’s aging population for exercise and rehab equipment to combat immobility, muscular atrophy, and the epidemics of heart disease, hypertension, stroke, osteoarthritis, and... Read More
With the COVID-19 pandemic making it unsafe to conduct most on-site inspections, regulatory authorities in Malaysia are permitting remote assessments of some pharmaceutical manufacturing facilities outside the country. Malaysia’s Guidance Document on Foreign GMP Inspection, 7th edition, March 2021, published by Malaysia’s... Read More
On July 1, 2016, Malaysia’s Medical Device Authority (MDA) made it mandatory for all foreign manufacturers to register their medical device products with the MDA. These medical device registrations would be valid for 5 years, which means re-registration is now starting. Although the... Read More