Malaysia offers one of Southeast Asia’s most robust and dynamic markets for foreign medical device manufacturers seeking emerging market opportunities.
In order to obtain market authorization to sell your medical device in Malaysia, you must first register your product with the Malaysian Medical Device Authority (MDA). Registration with Malaysian regulators is done electronically through the web-based Medical Device Centralised Application System (MeDCASt), providing a relatively efficient and cost-effective application process for foreign companies.
The Malaysian medical device registration process
If your device has been approved in one of the recognized reference markets of US, Europe, Australia, Japan and/or Canada, you will be able to leverage this approval and complete a simplified registration process. To register your medical device in Malaysia, you must:
- Determine your medical device or IVD classification using Appendix I of Medical Device Regulations 2012. Medical devices are classified as Class A (exempt), Class A (active/sterile/measuring), Class B (low to moderate risk), Class C (moderate to high risk) and Class D (highest risk), similar to the classification scheme used in Europe.
- Appoint an in-country Malaysia Authorized Representative to manage you device registration, and authorize a distributor to import post approval.
- Obtain a technical review of your documentation, including ISO certificate, labeling, CE Certificate, etc., from a licensed Conformity Assessment Body (CAB).
Prepare an abridged Technical File using ASEAN Common Submission Dossier Template (CSDT) format and submit the application online using the MDA Medical Device Centralized Online System (MeDCASt). Registrants should promptly address payment of application and licensing fees to the MDA. Payment is due within 30 days of notification and must be done with a hand delivered local bank draft.
For a detailed look at the medical device registration process in Malaysia, view our regulatory chart.
Emergo can support the registration of your medical device in Malaysia
With an office in Kuala Lumpur, Emergo can assist with your registration and interact with the Medical Device Authority on your behalf. Here’s how we can help:
- Our presence in Kuala Lumpur allows us to efficiently interact with regulators on your behalf.
- We are fully capable of acting as your Malaysia Authorized Representative if you have no local office in the country.
- Our team of expert consultants have helped clients register their devices in more than 20 markets worldwide, including Malaysia.
- We can use your Malaysia documentation to ease your entry into additional Southeast Asian medical device markets according to your business strategy.
Please contact us to learn more about medical device registration in Malaysia.