Insights
Stay updated with Malaysia’s latest medical device regulations, events, newsletters, and expert industry articles.
Regulatory Updates
Medical Device Regulations
Faulty tubes or pacemaker or even a leaking catheter are the last things patients need because they may pose risks to their life. This is one good reason for the Malaysian government to impose the regulation to make it compulsory for manufacturers of medical devices to register their products. The law that we are talking […]
New Law Helps to Regulate Manufacturers of Medical Devices
Imagine having faulty implants or pacemaker that start to give way not long after they are placed in your body. They are meant to save your life but do not meet the expectation. These are some of the concerns that had given birth to the Medical Device Regulations 2012. This new law helps to regulate […]
Blog
Can You Change Your LAR in Malaysia? The Full Transfer Guide
Quick Answer Yes — you can change your Local Authorised Representative in Malaysia. Device registrations can be transferred from one LAR to another via a formal process with the Medical Device Authority (MDA). The critical variable is the cooperation of your outgoing LAR — because device registrations are held under the LAR’s Establishment Licence, the […]
LAR Post-Approval Responsibilities in Malaysia
Quick Answer After a medical device is registered in Malaysia, the LAR’s responsibilities do not end — they shift from registration to ongoing compliance. The LAR is the legally responsible entity for post-market surveillance, mandatory problem reporting (adverse event reporting), field safety corrective actions, distribution records management, change notifications, and registration renewal. All of these […]
How to Appoint a LAR in Malaysia?
Quick Answer To appoint a LAR in Malaysia, you must: identify a company that holds a valid MDA Establishment Licence for the LAR role and a current GDPMD certificate; conduct due diligence on their regulatory expertise and track record; negotiate and sign a LAR agreement covering scope, responsibilities, and termination; issue a Letter of Authorization […]
Events
New CE Marking for Medical Devices Training
Fee: RM1500.00 PER PAX Only For Early Bird**Fee will be RM 2000.00 for registration after 28th February (100% HRDF claimable The workshop provides an overview of “The NEW CE MARKING.” It goes into detail on specific critical subjects for the manufacturer and its Authorised Representative and outlines the changes a manufacturer must consider. The concepts […]
Exhibit Permit for SE-Asia Healthcare & Pharma Show
GET YOUR PERMIT TO EXHIBIT FOR SE-ASIA HEALTHCARE AND PHARMA SHOW Under the Medical Device and Pharmaceutical law in Malaysia, all exhibitor must notify the respective Malaysian Authority in order to be permitted to exhibit its nonregistered medical devices and pharmaceutical products. 根据马来西亚的《医疗器械和药品法》，所有参展商务必通知各自的马来西亚当局，以获准展示其未注册的医疗器械和药品。 Have you done yours? 您已经知会主办单位了吗？ Avoid the stress, running around in circles and wasting […]
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