Indian Regulators Clarify Requirements for Medical Device Registrations, Clinical Trials

New orders from the Indian Ministry of Health & Family Welfare’s Central Drugs Standard Control Organization (CDSCO) clarify some requirements regarding the country’s sometimes opaque medical device registration and clinical trial regulations.

First, CDSCO has reiterated 14 categories of devices that do fall under India’s Drugs and Cosmetics Act and qualify for regulation:

  • Disposable hypodermic syringes
  • Intra ocular lenses
  • Disposable hypodermic needles
  • I. V. cannulae
  • Disposable perfusion sets
  • Bone cements
  • IVD devices for HIV, HBsAg and HCV
  • Heart valves
  • Cardiac stents
  • Scalp vein stents
  • Drug eluting stents
  • Orthopedic implants
  • Catheters
  • Internal prosthetic replacements
 

Any medical devices that do not fall into one of the categories listed above “do not require any registration, licence, permission or NOC for their import or manufacture, sale and distribution so far as the provisions of the Drugs and Cosmetics Act and Rules made thereunder are concerned,” states the CDSCO order.

Indian regulators have also provided further clarification on their clinical trial requirements for medical devices. Based a set of Expert Committee recommendations finalized by the Ministry of Health & Family Welfare, several components of clinical trial procedures for medical devices will resemble requirements in place for drugs and vaccines.

Specifically, device clinical trial approvals, investigator accreditations, site and ethics committee approvals will be “similar” to pharmaceutical clinical trial requirements and processes.

These clarifications from CDSCO do not preclude future changes to the Indian medical device registration process, but should hopefully provide adequate information to device manufacturers interested in commercialization in India but unsure of how to do so.

Disclaimer: Some devices including blood grouping sera, ligatures and condoms may still require registration as drugs by CDSCO. 

Stewart Eisenhart

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