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- Preparation: Gather all required documents, including clinical data, technical documentation, manufacturing licenses, and ISO certifications.
- Monitor the device’s performance and report any adverse events to CDSCO.
- Regulations: Familiarize yourself with the Medical Devices Rules, 2017, and any other relevant guidelines issued by the Central Drugs Standard Control Organization (CDSCO).
- CDSCO Registration: It signifies that the device has met the regulatory requirements set by CDSCO, ensuring it is safe, effective, and compliant with Indian medical device regulations.
- Familiarize Yourself: Review the Medical Devices Rules, 2017, and any relevant updates. Understand the classification criteria and requirements for Class B devices.
- Time Required: Varies depending on the complexity of the device and the completeness of the documentation. Typically, this stage can take from a few weeks to several months.
- Understand Regulations: Familiarize yourself with the Medical Devices Rules, 2017, which govern the registration of medical devices in India.
- Regulatory Compliance: Adhere to the latest Medical Devices Rules, 2017, and any other relevant guidelines issued by CDSCO. Ensure that all updates are in line with current regulatory requirements.
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