Medical Devices in Malaysia – Tips to Master Market Access!

Malaysia has a well established regulatory system for medical devices governed by the Health Sciences Authority (HSA). The market has a reputation for being difficult to enter from a regulatory perspective – often deemed time consuming and complicated.

Clinica recently published a story on ‘cracking the market’ in Malaysia, using the words of experience from Dr Henningsen, who has first-hand experience of accessing the market in Singapore. Dr Henningsen described the regulations as:

• complex – but well documented;
• meticulous – but not unreasonable; and
• offering a slow e-system – but it works.

With the system based primarily on the common and well understand framework created by the Global Harmonization Task Force – the challenges really shouldn’t be insurmountable for manufacturers. Key characteristics of the Singapore regulations are: essential principles, device classification rules, and common submission dossier templates for technical documentation – similar to the Summary Technical Documentation template originally developed by the GHTF (now replaced by the International Medical Device Regulators Forum (IMDRF)). Requirements are well described in guidance documents which can be obtained for the HSA website.

Dr Henningsen noted that the regulatory agency for medical devices, the HSA, “likes to ask questions” – but is also open for discussions, with HSA reviewers accessible by email and phone.

“You usually know your reviewer by name – and it is worth trying to build up a relationship with that person,” he told delegates attending the Informa Life Sciences meeting held in London between 3-5 June. “You can discuss most things with them; they are quick at giving reasonable answers and there is no need to travel to Singapore,” he added. “Going through a third party is often more trouble than it is worth”.

Classification defines available submission options and should be a starting point for all manufacturers. Submission process can then be followed accordingly.

If you would like some more information about accessing Malaysia’s medical device market, contact KD&A for a personalized quote. We have many years of medical device regulatory experience, obtaining certification for a broad range of devices across a large group of markets.