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- Understand Regulations: Familiarize yourself with the Medical Device Act 2012, the Medical Device Regulations 2012, and any specific guidelines provided by the Medical Device Authority (MDA).
- Preparation Time: This includes gathering and preparing all necessary documentation and ensuring that everything meets regulatory requirements. This phase can vary depending on how quickly you can compile and verify all the required information.
- 2024-09-19Understand Regulations: Familiarize yourself with the Medical Device Act 2012 and the Medical Device Regulations 2012. Review the guidelines on the Medical Device Authority (MDA) website.
- Regulations: Familiarize yourself with the renewal requirements outlined in the Medical Device Act 2012 and the Medical Device Regulations 2012.
- Stay Informed: Keep up-to-date with any changes in regulations or standards that may affect your device or its registration.
- Familiarize Yourself: Review the Medical Device Act 2012 and the Medical Device Regulations 2012 to understand the regulatory framework and requirements for Class A devices.
- After obtaining Class A medical device registration in Malaysia, several important considerations and ongoing responsibilities should be noted to ensure continued compliance with regulations and to maintain the registration status.
- Act: The primary legislation governing medical devices in Malaysia is the Medical Device Act 2012 (Act 737).
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