How to apply for Class C medical device registration in Malaysia?

In Malaysia, the registration of Class C medical devices is regulated by the Medical Device Authority (MDA) under the Ministry of Health. Here’s a step-by-step guide on how to apply for the registration of a Class C medical device:

1. Understand the Classification of Medical Devices

Class C medical devices in Malaysia are considered medium to high-risk. It's important to ensure that your product falls within this category according to the Medical Device Regulations 2012.

2. Appoint an Authorized Representative (if applicable)

For foreign manufacturers, you must appoint a local Authorized Representative (AR) based in Malaysia to handle the registration process.
The AR must be licensed by the MDA and will act as a liaison between the manufacturer and the MDA.

3. Prepare a Common Submission Dossier Template (CSDT)

The CSDT is a structured dossier that includes technical and clinical information about the medical device. It typically includes:

Device description
Intended use
Risk analysis and management
Clinical evidence (where applicable)
Manufacturing process information
Quality management system (e.g., ISO 13485)
Labeling and instructions for use

4. Conduct Conformity Assessment

You must conduct a Conformity Assessment to demonstrate compliance with the regulatory requirements. This may involve obtaining certification from a Conformity Assessment Body (CAB) in Malaysia or from another recognized certification body.
Class C devices may require either:
- Full Quality Assurance (FQA) Audit or
- Type Examination

5. Obtain a Medical Device Registration Certificate

The registration must be completed through the Medical Device Centralized Online Application System (MeDC@St). You will need to create an account and upload all necessary documents, including the CSDT and evidence of conformity assessment.
Pay the necessary fees for the application. The fees depend on the class of the device and the type of submission.

6. Review by MDA

The MDA will review your application and may request additional information or clarifications.
The review process for Class C devices may take several months due to the higher risk classification.

7. Post-Registration Obligations

Once your device is approved, you must adhere to post-market surveillance requirements, including reporting adverse events and device defects to the MDA.
You will also need to renew your registration before it expires (typically after 5 years).

Summary of Documents Required:

Device classification document
Common Submission Dossier Template (CSDT)
Conformity Assessment report
Manufacturer’s declaration of conformity
Proof of appointment of an Authorized Representative (if applicable)
Quality management system certification (e.g., ISO 13485)