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- Regulatory Compliance: Regularly review and stay updated with changes in the Medical Devices Rules, 2017, and other relevant CDSCO guidelines to ensure ongoing compliance.
- Monitor Device Performance: Implement a system to monitor the performance of the device in the market. Collect and analyze feedback, and track any adverse events or product complaints.
- Review Regulations: Familiarize yourself with the Medical Devices Rules, 2017, and any relevant CDSCO guidelines specific to Class A medical devices.
- 2024-08-27Post-Market Surveillance: Implement a system for monitoring the device’s performance in the market. This includes tracking any adverse events or complaints and reporting them to CDSCO as required.
- Medical Devices Rules, 2017: Compliance with the Medical Devices Rules, 2017, which govern the regulation of medical devices in India. These rules outline the classification, registration, and regulatory requirements for medical devices.
- 2024-08-27Device Description: Detailed description of the medical device, including its intended use, design, materials, and specifications.
- Application Completeness: If the application is complete and all required documents are correctly submitted, the process tends to be faster. Incomplete or incorrect applications can lead to delays.
- 2024-08-27Legal Registration: Your company must be legally registered and compliant with Indian laws.
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