The time it takes to obtain Class A medical device MDA registration in Malaysia typically ranges from 6 to 12 weeks. However, the exact duration can vary depending on several factors such as the completeness of the application, the type of device, and whether the Medical Device Authority (MDA) requests additional information.

Timeline Breakdown:

1. Document Preparation and Application Submission (1-2 weeks):

   • Document Preparation: Manufacturers (or their Authorized Representatives for foreign companies) need time to gather necessary documentation, including technical files, risk assessments, labeling, ISO certifications, etc.
   • Application Submission: Once all documents are ready, the online application is submitted via the Medical Device Registration System (MDRS). This process typically takes 1-2 weeks.

2. MDA Review and Evaluation (4-8 weeks):

   • Initial Review: After submission, the MDA will begin reviewing the documents. For Class A devices, this process typically takes around 4 to 8 weeks.
   • If the MDA requires additional documentation or clarification, the review timeline may be extended.

3. Issuance of Registration Certificate (1-2 weeks):

   • Once the application is approved, the MDA will issue the registration certificate, which typically takes 1-2 weeks after approval.

Summary:

• The entire process for obtaining Class A medical device MDA registration typically takes between 6 and 12 weeks, assuming all documents are complete and no additional information is required.