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Medical Device Registration in Malaysia

ANSWERED ON THIS PAGE:

  • What is the medical device registration process in Malaysia?
  • Do foreign manufacturers need in-country representation in Malaysia?
  • How are medical devices classified in Malaysia?

Malaysia offers one of Southeast Asia’s most robust and dynamic markets for foreign medical device manufacturers. To obtain market authorization in Malaysia, you must first register your product with the Malaysian Medical Device Authority (MDA). Registration with the MDA is done electronically through the web-based Medical Device Centralised Online Application System (MeDC@St), and can only be done by the local Authorized Representative.

The Malaysian medical device registration process

If your device is approved in one of the recognized reference markets (US, European Union, Australia, Japan or Canada), you can leverage this approval and follow a simplified registration process as outlined below. Download our registration process chart on Malaysia to better understand this process. Here are the basic steps:

  • Determine your classification. Medical devices are classified as Class A (low risk), Class B (low to moderate risk), Class C (moderate to high risk) and Class D (highest risk), similar to the classification scheme used in the European Union.
  • Appoint an in-country Malaysia Authorized Representative to manage your device registration.
  • Prepare an abridged Technical File including your reference country approval, test reports, Malaysian Essential Principles checklist, Malaysian Declaration of Conformity, QMS Certificate, etc. Use ASEAN Common Submission Dossier Template (CSDT) format technical file.
  • Request a technical review of your documentation by a licensed Conformity Assessment Body (CAB).
  • After satisfactory audit by CAB, the verification Certificate is issued.
  • Submit application with CAB certificate and audit report to MDA.
  • MDA begins review. Application will be returned with 90 days to respond for any additional information requests.
  • Upon satisfactory review, MDA grants the registration.

Emergo can help register your medical device or IVD 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 team of expert consultants in the US and Malaysia allows us to efficiently register your devices and interact with the MDA on your behalf.
  • We are fully capable of acting as your Malaysia Authorized Representative if you have no local office in the country or simply wish to outsource the regulatory functions of a local office.
  • We can help you access other medical device markets in Southeast Asia according to your business strategy.

Malaysia is a dynamic and growing medical market in SE Asia. Let Emergo help you access this growing market.

Common Questions

What are MDA review timelines?
Review timelines in Malaysia vary by device classification. Please download our regulatory chart which explains the process for each class and indicates the time, cost and complexity of approval for each class of device.

When do we need to pay application and licensing fees?
Payment is due within 30 days and must be done with a hand-delivered local bank draft.

Are there any local labeling requirements?
Yes, the MDA registration number and contact information of the Malaysia AR must be included. Additionally, labeling for lay-use devices must be in Bahasa-Malay (and may also include English).