The processing time for Class C medical device registration with the Malaysian Medical Device Authority (MDA) generally ranges from 6 to 12 months. This timeframe can vary depending on several factors, including the completeness of the application, responsiveness to additional information requests, and MDA's workload.

Factors Affecting Processing Time

1. Completeness and Quality of Application: Incomplete or poorly organized applications can delay processing, as MDA may require additional documentation or clarification.
2. Responsiveness to Queries: If MDA requests further information, timely responses help keep the process on track.
3. MDA’s Current Workload: Processing times may vary if MDA is handling a high volume of applications.

Ways to Minimize Processing Delays

• Ensure Application Completeness: Verify that all required documents are correctly formatted and submitted according to MDA’s guidelines.
• Promptly Address Requests for Additional Information: Respond to MDA queries as quickly as possible.
• Use an Experienced Authorized Representative: If you are a foreign manufacturer, working with an experienced local representative familiar with MDA requirements can streamline communication and ensure compliance.

This 6 to 12-month timeline is an estimate; MDA's official updates or guidance can provide more specific timelines.

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