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Borderline & Combination Products

Borderline products​

A borderline product is one where it is unclear whether it should be regulated as a medical device, drug, cosmetic, or food. Common borderline areas in India:

  • Device/drug combinations — e.g., drug-coated stents, drug-eluting bone cement;
  • Device/cosmetic — e.g., UV-protective eyewear, teeth whitening kits;
  • Device/AYUSH — traditional preparations used with device claims;
  • Wellness software vs SaMD.

How CDSCO handles borderline cases​

CDSCO will determine the primary mode of action. If the device component is primary and the drug component is secondary, MDR 2017 applies (and the drug component requires a separate drug licence). If the drug is primary, drug regulation applies.

Manufacturers should submit a pre-submission inquiry (PSI) to CDSCO seeking formal clarification on borderline classification status before conducting full developmental studies. While India does not have a formal advisory procedure equivalent to the EU SCENIHR, CDSCO will typically respond to written requests within 30-45 days.

Combination products​

India does not yet have a dedicated combination product regulation equivalent to 21 CFR Part 3 (USA) or Article 1(8) EU MDR. A pragmatic approach — seek guidance from CDSCO — is recommended before submission.