The timeline for Class A medical device MDA registration in Malaysia can vary, but the process generally follows a set pattern. Here’s an overview of the typical timeline:

1. Preparation of Documents and Application (1-2 weeks)

• Document Preparation: The manufacturer (or Authorized Representative for foreign manufacturers) needs time to gather and prepare the necessary documentation, such as:
  • Technical files.
  • Risk management documents (e.g., ISO 14971).
  • Quality management system certificates (e.g., ISO 13485).
  • Labeling and instructions for use (IFU).
  • Test reports and performance data (if required).
• Account Setup: If you don’t already have an account on the MDA’s Medical Device Registration System (MDRS), you will need to create one and gather all required information about the device and manufacturer.
• This stage can take 1 to 2 weeks depending on how quickly the documents are prepared and the account setup.

2. Submission of Application (1-2 days)

• After gathering all the required documents and filling in the necessary information, the registration application can be submitted through the MDRS portal.
• This step usually takes 1 to 2 days, as long as the submission is complete and all documents are ready.

3. MDA Review and Evaluation (4-8 weeks)

• Review Process: Once the application is submitted, the Medical Device Authority (MDA) will review the documents to ensure that they meet regulatory requirements. For Class A devices, this step typically takes about 4 to 8 weeks.
  • The MDA will review the submitted documentation for compliance with safety, performance, and labeling standards.
  • If additional information is required, the MDA may request clarification or further documentation, which may delay the process.

4. Issuance of Registration Certificate (1-2 weeks)

• If the application is successful and all requirements are met, the MDA will issue a Medical Device Registration Certificate. The certificate typically takes 1 to 2 weeks to be issued after the approval.

Total Timeline:

• Overall Process: From the preparation stage to the issuance of the registration certificate, the total timeline for Class A medical device MDA registration is usually 6 to 12 weeks.
  • If there are no complications, the process may be on the shorter end, around 6 weeks.
  • If there are requests for additional information or document clarifications, it may take closer to 12 weeks or even longer in exceptional cases.

Factors That Could Affect the Timeline:

• Completeness of the Application: If your application is missing information or if documents need further clarification, the timeline could be extended.
• Type of Device: Although Class A devices are low-risk and have a relatively simpler process, more complex devices might take longer to evaluate.
• MDA Workload: The MDA’s internal processing times might vary based on their workload or backlog at the time of submission.

Summary:

• Document preparation: 1-2 weeks.
• Submission of application: 1-2 days.
• MDA review and evaluation: 4-8 weeks.
• Issuance of certificate: 1-2 weeks.

The entire process for registering a Class A medical device with the MDA in Malaysia typically takes around 6 to 12 weeks, depending on the completeness of your application and the MDA's review process.

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