Skip to main content

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 determines the primary mode of action (PMOA). If the device component is primary and therapeutic action is primarily achieved through the device, MDR 2017 applies; the drug component requires a separate drug approval. If the drug component is primary, the product is regulated as a drug under the Drugs and Cosmetics Act, 1940.

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.