To apply for Class D medical device registration with the Medical Device Authority (MDA) in Malaysia, you can follow these steps and handle the application through the MDA’s online platform.
Steps to Apply for Class D Medical Device Registration:
Determine Device Classification:
- Ensure that your device is correctly classified as Class D based on MDA classification criteria.
Prepare Required Documentation:
- Gather all necessary documents, including:
- Device description and intended use
- Risk management file (ISO 14971)
- Clinical evaluation report
- Quality management system documentation (ISO 13485)
- Labeling and packaging information
- Manufacturing process details
- Declaration of conformity
- Ensure that all documents are complete, accurate, and comply with MDA guidelines.
Access the MDA e-Register:
- Visit the MDA official website: www.mda.gov.my.
- Navigate to the e-Register section for medical device registration.
Create an Account:
- If you do not already have an account, register for one on the e-Register platform.
Log In to the e-Register:
- Use your credentials to log into the system.
Complete the Application Form:
- Select the option for Class D medical device registration and fill out the online application form.
Upload Required Documents:
- Upload all necessary documentation as outlined in the registration guidelines.
Pay Registration Fees:
- Follow the prompts to make the required payment for your application. Fees can vary based on the complexity of the device.
Submit the Application:
- Review all information and documentation before submission. Ensure everything is accurate and complete, then submit your application.
Monitor Application Status:
- After submission, you can track the status of your application through the e-Register system.
Respond to Queries:
- Be prepared to address any inquiries from the MDA during the review process promptly.
Receive Registration Certificate:
- If approved, you will receive a registration certificate. If issues arise, you may need to rectify them and resubmit.
Where to Handle the Application:
- Online Platform: All registration applications for Class D medical devices are handled through the MDA's e-Register system, which is accessible via their official website.
Important Notes:
- Consult MDA Guidelines: Regularly check the MDA website for updates on procedures and requirements.
- Consider Consultation: If needed, consult with regulatory experts to ensure your application is complete and complies with all necessary regulations.
By following these steps and utilizing the MDA’s online resources, you can effectively navigate the application process for Class D medical device registration in Malaysia.
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