In the Indian medical device regulatory landscape governed by the Central Drugs Standard Control Organization (CDSCO), an “endorsement” refers to the official approval or authorization granted for modifications or additions to an existing medical device manufacturing license. This endorsement process is facilitated through various MD forms, each catering to specific scenarios.
Types of Endorsements:
- Endorsement for Additional Manufacturing Site:
- If a manufacturer holding a valid manufacturing license intends to manufacture the same medical device at a new location, they must apply for an endorsement on their existing license using the respective form.
- Endorsement for Adding a New Medical Device:
- Manufacturers wishing to expand their product portfolio by adding a new medical device to their licensed manufacturing activities must obtain an endorsement on their existing license.
- Endorsement for Change in Licensed Manufacturer’s Name or Address:
- Any alteration in the manufacturer’s legal name or registered address necessitates an endorsement on the corresponding license.
- Endorsement for Import License:
- Importers of medical devices holding a valid import license may require endorsements for changes such as adding new devices, changing the manufacturer’s details, or modifying the approved models/specifications.
General Timeline and Procedure for Obtaining Endorsement
While the exact duration may vary depending on factors like the type of endorsement, complexity of the device, and CDSCO workload, the typical process involves:
- Application Preparation and Submission:
- Gather all required documents as per the specific MD form checklist.
- Submit the application online through the SUGAM portal (cdscomdonline.gov.in).
- Scrutiny by CDSCO:
- The submitted application undergoes a thorough review for completeness and adherence to regulatory requirements.
- Inspection (if applicable):
- In certain cases, CDSCO might conduct an on-site inspection of the manufacturing facility or importer’s premises to verify compliance.
- Grant of Endorsement:
- Upon satisfactory evaluation, CDSCO issues the endorsement, updating the relevant MD license.
Who is Eligible to Apply for Endorsements?
Generally, any entity holding a valid manufacturing or import license under the specified MD forms is eligible to apply for endorsements.
Key Points to Consider
- Meticulous Documentation: Ensure all documents are accurate, complete, and up-to-date.
- Regulatory Compliance: Adhere to CDSCO guidelines and maintain quality management systems (ISO 13485).
- Timely Updates: Promptly inform CDSCO of any changes in manufacturing/importing activities or product details.
- Professional Guidance: Seek expert advice from regulatory consultants for a seamless application process.