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- 2024-11-05Confirm that your device is classified as Class D, which pertains to high-risk medical devices, according to MDA classification criteria.
- Familiarize yourself with the Medical Device Act 2012 and the Medical Device Regulations 2012. Understand the specific requirements for Class D devices and the implications of their high-risk classification.
- The time cycle for applying for Class D medical device registration with the Medical Device Authority (MDA) in Malaysia can vary based on several factors, including the complexity of the device and the completeness of the application.
- Confirm that your device is classified as Class D based on the MDA’s classification criteria. This classification is for high-risk medical devices.
- The periodic renewal of Class D medical device registration with the Medical Device Authority (MDA) in Malaysia involves specific standards and processes to ensure continued compliance with regulatory requirements.
- Adhere to the Medical Device Act 2012 and the Medical Device Regulations 2012. Ensure that your device continues to meet the safety, efficacy, and quality requirements outlined in these regulations.
- Familiarize yourself with the Medical Device Act 2012 and related regulations, including the Medical Device Regulations 2012, to understand the legal requirements for registration.
- 2024-11-05Continue to comply with all applicable regulations and standards, including ISO 13485 and other relevant guidelines.
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