The cost and time required to register a Class A medical device with the Medical Device Authority (MDA) in Malaysia depend on several factors, including the type of device, whether it is locally manufactured or imported, and the specifics of the regulatory process. Here is a general overview of the costs and timeline involved:

Cost of Registration:

The cost to register a Class A medical device with the MDA is generally lower compared to higher-risk devices (Class B, C, or D). However, the exact fees can vary based on the nature of the device and whether additional services are needed (e.g., consultation, translations).

As of the latest available data, the registration fees for Class A devices are typically as follows:

• Local Manufacturers (For Malaysian-based companies):
  • The cost for registering a Class A medical device is generally RM 500 to RM 1,000 (Malaysian Ringgit) per device.
• Foreign Manufacturers (For devices imported into Malaysia):
  • The registration fee for foreign manufacturers is typically RM 1,000 to RM 1,500 (Malaysian Ringgit) per device.

These fees are non-refundable and are paid when submitting the registration application through the MDA’s MDCAS portal.

Note: The registration fees may be updated periodically, so it’s important to check the MDA website for the most current fee schedule or consult with the MDA directly for more specific costs related to your product.

Time Required for Registration:

The time required for registering a Class A medical device with MDA is relatively quick compared to higher-risk categories, as Class A devices are considered low risk and generally do not require extensive documentation or auditing. However, the registration timeline can still vary depending on the completeness of your application and whether the MDA requires additional information or clarification.

• Average Time for Registration:
  • Typically, 2 to 3 months is required for the approval of Class A medical devices after submission.
• Factors That May Affect the Timeline:
  • Completeness of the Application: If the application is incomplete or requires corrections, it may delay the approval process.
  • MDA Review: MDA may need to verify the accuracy of the submitted documents or request additional information, which can add time.
  • Public Holidays and other administrative delays may extend the processing time.
• Faster Registration: In some cases, Class A devices may be registered more quickly if the documentation is straightforward and complete, and if there are no issues with the risk classification.

Steps in the Registration Timeline:

1. Document Preparation: Time for gathering and preparing required documents (e.g., Certificate of Free Sale, product labeling, risk classification) can take a few days to weeks, depending on the complexity of the device.

2. Application Submission: Once the application is submitted through the MDCAS portal, MDA will begin processing the application.

3. MDA Evaluation: MDA reviews the submitted documents. For Class A devices, this process generally takes around 1 to 2 months.

4. Approval and Certification: After successful review, MDA will issue a Medical Device Registration Certificate. This step typically takes another 2 to 4 weeks after document approval.

Summary:

• Cost: RM 500 to RM 1,500 (depending on whether the manufacturer is local or foreign).
• Time: Typically 2 to 3 months, although it could be faster if the application is complete and no issues arise.

For more accurate and up-to-date information, it is recommended to check the MDA’s website or consult a Local Authorized Representative (LAR) in Malaysia to assist with the process.

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