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- Regulatory Framework: Familiarize yourself with the Drugs and Cosmetics Act, 1940, and the Medical Devices Rules, 2017.
- Understand Regulations: Familiarize yourself with the Drugs and Cosmetics Act, 1940, and the Medical Devices Rules, 2017. Class D devices are high-risk, requiring stringent compliance.
- Review Regulations: Familiarize yourself with the Drugs and Cosmetics Act, 1940, and the Medical Devices Rules, 2017. Understand the specific requirements for Class D medical devices, which are high-risk devices.
- Activities: Gathering and preparing all necessary documentation, including technical files, clinical data, and quality management system details. This phase depends on the readiness of your documentation and the complexity of the device.
- 2024-08-30Understand Regulations: Familiarize yourself with the Drugs and Cosmetics Act, 1940, and the Medical Devices Rules, 2017.
- Registration Renewal: Registration for Class D medical devices is typically valid for 5 years. Start the renewal process at least 6 months before the expiration date. Ensure that all necessary documents and fees are submitted for renewal.
- Adherence to Medical Devices Rules, 2017: Continue to comply with the Drugs and Cosmetics Act, 1940, and the Medical Devices Rules, 2017, which govern the manufacturing, labeling, and post-market activities of medical devices.
- Review Guidelines: Familiarize yourself with the Drugs and Cosmetics Act, 1940, and the Medical Devices Rules, 2017.
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