The cost and timeline for obtaining Class A medical device registration with the Medical Device Authority (MDA) in Malaysia depend on factors such as the specific device and whether you are a local or foreign manufacturer. Here’s an overview of the estimated costs and timelines:

1. Cost of Class A Medical Device Registration

• Application Fee: The MDA charges a registration fee, which varies depending on the device type and the applicant’s location (local vs. foreign). Generally, the fees for Class A devices are lower than those for higher-risk categories.
• Authorized Representative (AR) Fees: If you are a foreign manufacturer, you will need to appoint a local Authorized Representative (AR) to handle the registration on your behalf. AR service fees can vary widely, typically ranging from a few thousand to several thousand Malaysian Ringgit (MYR), depending on the services offered.
• ISO 13485 Certification Costs: If your manufacturing facility is not already ISO 13485 certified, obtaining this certification can involve significant costs, typically ranging from USD 3,000 to USD 10,000 or more, depending on the complexity of the facility and any consulting services required.

Estimated Cost Breakdown

• MDA Registration Fee: Generally from MYR 1,000 to MYR 3,000 (approx. USD 200 to USD 650), though this varies based on the specific device.
• AR Fees (if applicable): From MYR 2,000 to MYR 10,000+ (approx. USD 450 to USD 2,200), depending on the representative.
• ISO 13485 Certification (if required): USD 3,000 to USD 10,000 or more, depending on the location and complexity of the manufacturing facility.

Note: Exact fees should be confirmed with the MDA and any authorized representatives, as costs can vary based on specific device requirements.

2. Timeline for Class A Medical Device Registration

• Document Preparation: Preparing documentation, including ISO 13485 certification (if not already in place) and compiling the technical file, can take 1-3 months.
• MDA Review and Approval: For Class A devices, the MDA’s review process is generally shorter compared to higher-risk devices. Once the application is submitted, approval can typically take 1-3 months, depending on the completeness of the documentation and any additional requests from the MDA.

Summary of Timeline:

• Total Time (Estimate): 2-6 months from preparation to approval, depending on the readiness of the documentation and the MDA’s processing time.

Additional Factors That May Affect Cost and Timeline:

• Incomplete Documentation: Missing or inadequate documentation can delay the process, as MDA may request additional information.
• AR Coordination: Working with an AR may add time if they need to clarify details with the manufacturer.
• ISO 13485 Certification: If ISO 13485 certification is not already obtained, securing it can significantly extend the timeline.

By ensuring accurate documentation and ISO certification in advance, applicants can streamline the process, helping to reduce the overall time and cost for obtaining Class A medical device registration in Malaysia.

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