CDSCO Post Approval Changes in Medical Devices

India’s Central Drugs Standard Control Organization (CDSCO) mandates that any modifications to medical devices post-approval, such as changes in design, intended use, or materials, must be reported. According to the Drugs and Cosmetics Rules, these changes are classified as either major or minor. See Sixth Schedule of the Medical Device Rules 2017. 

Major Changes:  

• • Material of construction 

• • Design which shall affect quality in respect of its specifications, indication 

• • For use; performance and stability of the medical device 

• • The intended use or indication for use  

• • The method of sterilization 

• • The approved shelf life 

• • The name or address of: 

• • • the domestic manufacturer or its manufacturing site 

• • • overseas manufacturer or its manufacturing site (for import only) 

• • • authorized agent (for import only) 

• • Label excluding change in font size, font type, color, label design 

• • Manufacturing process, equipment or testing which shall affect quality of the device 

• • Primary packaging material.

These require prior approval from the CDSCO and changes must be implemented within 60 days. 

Minor Changes:  

• • Design which shall not affect quality in respect of its specifications, indication for use, performance and stability of the medical device 

• • In the manufacturing process, equipment, or testing which shall not affect quality of the device 

• • Packaging specifications excluding primary packaging material 

These changes require to be reported within 30 days to become effective. 

Indian medical device importers must prepare and submit necessary documentation, pay applicable fees, undergo a review, and receive updated approval from the CDSCO, ensuring ongoing compliance. 

Legal Metrology Requirements for Medical Devices in India: 

To sell medical devices in India, manufacturers and importers must obtain an MD-14/MD-15 Import License and comply with the Legal Metrology Act. This includes adhering to the Essential Commodities Act pricing rules and securing an LMPC Certificate. 

• •  LMPC Certification Process: Importers need to submit business and GST registration, identity proofs, a Model Approval Certificate, and a Pollution Control NOC to obtain the LMPC certificate.
  • Legal Metrology Packaging & Labelling Law: Pre-packed goods must clearly display the manufacturer’s details, product name, quantity, price, and dimensions if applicable.
  • Products Exempt from LMPC Certification: Extremely light or heavy medical devices, certain in-vitro diagnostics (IVDs), and products governed by the 1995 Drugs (Price Control) Order do not require LMPC certification. 

Medical Device Re-registration/Renewal Process in India: 

Manufacturers must adhere to CDSCO’s 2017 Medical Device Rules, submitting documents from the Retention Checklist and paying required fees every five years to renew import licenses. As per the CDSCO’s statement on May 15, 2024, endorsements to the original application remain valid only as long as the base license is valid. 

India Medical Device and IVD Fee Overview:

Retention fees, payable every five years, range from $50 for Class A to $3,000 for Class D, per product and site, according to MDR 2017. Late fees apply. 

India License Renewal Requirements:

Manufacturers must renew licenses every five years by submitting necessary forms, current licenses, sales data, and ISO certificates. Required documents include a covering letter and no-change declarations. Late submissions incur penalties. 

For more detailed information on these regulations, read more on the CDSCO website.

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If you have any questions about the CDSCO’s post approval changes for medical devices and IVDs, reach out to us so our team can assist you.

Learn how MedEnvoy can assist you:

• • India Authorized Importer
  • RA Consulting
  • QA Consulting