The time required for CDSCO registration of Class A medical devices can vary based on several factors, including the completeness of the application, the complexity of the device, and the efficiency of the review process. Here’s an overview of the typical timeline and what the review process involves:

Timeline for CDSCO Registration

1. Preparation Time:

   • Document Compilation: This depends on how quickly you can prepare and compile the necessary documentation, such as the technical file, quality management system records, and ISO certification. This stage may take several weeks to months, depending on the complexity of the device and availability of documents.

2. Submission and Processing:

   • Application Submission: Once you submit the application through the CDSCO SUGAM portal, the initial processing time typically ranges from 4 to 6 weeks. This includes the time required to verify that the application and accompanying documents are complete and meet the regulatory requirements.
   • Additional Information Requests: If CDSCO requires additional information or documentation, the review process may be extended. The time required to respond to these requests can add to the overall timeline.

3. Review and Approval:

   • Document Review: The CDSCO review team will evaluate the submitted documents, which generally takes 4 to 8 weeks. This includes assessing the technical file, verifying compliance with standards, and ensuring that all required information is provided.
   • Inspection (if required): If an inspection of the manufacturing facility is necessary, this can add additional time. Inspections typically take place after the initial document review, and scheduling and conducting the inspection may add a few more weeks to the process.

4. Issuance of Registration Certificate:

   • Final Approval: Once the review is complete and any necessary inspections are conducted, CDSCO will issue the registration certificate. The issuance typically occurs within 1 to 2 weeks following final approval.

Overall Timeline:

• The entire process, from preparation to receiving the registration certificate, can take approximately 3 to 6 months. This timeline may vary based on the efficiency of the submission, the completeness of the application, and any additional requests for information.

Review Process Includes:

1. Initial Submission Review:

   • Document Completeness Check: Verification that all required documents and information are submitted and complete.
   • Fee Payment Confirmation: Ensuring that the application fee has been paid and recorded.

2. Technical Evaluation:

   • Technical File Review: Assessment of the device’s technical documentation, including design, performance data, and safety information.
   • Compliance Check: Verification that the device meets the requirements of the Medical Devices Rules, 2017, and any relevant standards.

3. Quality Management System Review:

   • ISO Certification Review: Verification of ISO 13485 or equivalent certification and assessment of the quality management system.

4. Risk Assessment:

   • Risk Management: Evaluation of the risk management procedures and safety data related to the device.

5. Labeling and Packaging Review:

   • Compliance Check: Review of the device’s labeling and packaging to ensure it complies with regulatory requirements.

6. Manufacturing Facility Inspection (if applicable):

   • Facility Inspection: If required, an inspection of the manufacturing facility to verify compliance with Good Manufacturing Practices (GMP) and other regulatory standards.

7. Adverse Event Reporting Review:

   • Post-Market Surveillance: Review of any reported adverse events or issues related to similar devices, if applicable.

8. Final Review and Approval:

   • Approval Decision: Final assessment and decision on the registration application.
   • Issuance of Certificate: Issuance of the registration certificate once all requirements are met and the application is approved.

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