The processing time for the registration of a Class A medical device with the Medical Device Authority (MDA) in Malaysia is typically 2 to 4 weeks after the submission of a complete and correct application through the Medical Device Centralized Application System (MDCAS).

Here is a more detailed breakdown of the processing timeline:

Processing Time Overview for Class A Medical Device Registration

1. Application Submission: Once the registration application is submitted on the MDCAS portal, it will be reviewed by MDA. The timeline depends on the completeness of the application and the documents provided.

2. Initial Review: MDA will conduct an initial review to ensure that all necessary documents are submitted and that the device meets the basic regulatory requirements for Class A devices. This step can take 1 to 2 weeks, depending on the volume of applications and the complexity of the device.

3. Approval Process:

   • If the application is straightforward and meets all the requirements, MDA typically processes the registration within 2 to 4 weeks.
   • Class A devices are generally considered low-risk, so the review process is quicker compared to higher-risk classifications (Class B, C, D).

4. Issuance of Registration Certificate: After MDA approves the application, they will issue a Medical Device Registration Certificate. This can take a few days to a week after the approval.

Factors That May Affect Processing Time

• Completeness of the Application: If your application is incomplete or if there are issues with the documentation (e.g., missing certificates or improper labeling), MDA may request additional information or corrections, which could delay the process.
• MDA Workload: The volume of applications being processed by MDA at any given time can affect how quickly your application is reviewed. However, for Class A devices, the processing time tends to be faster due to their low-risk nature.
• Compliance with Regulations: If the application complies with all MDA regulations and standards, it is likely to be processed more swiftly. Delays can occur if there are discrepancies in meeting labeling or quality management system requirements.

Summary Timeline for Class A Registration:

• Normal Processing Time: 2 to 4 weeks.
• Additional Time for Corrections: May extend if there are issues with the application that need to be addressed.

To ensure timely processing, it’s important to submit a complete and accurate application with all required documents.

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