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India Medical Device Regulations

Regulatory Agency

The Central Drugs Standard Control Organization (CDSCO), which operates under the Ministry of Health and Family Welfare, regulates all medical devices in India.

Medical Device Definition

Medical Device:

  • -Substances used for in vitro diagnosis and surgical dressings, surgical bandages, surgical staples, surgical sutures, ligatures, blood and blood component collection bag with or without anticoagulant under sub-clause (i) (Drugs and Cosmetics Act, 1940).
  • -Substances including mechanical contraceptives (condoms, intrauterine devices, tubal rings), disinfectants and insecticides notified in the Official Gazette under sub-clause (ii) (Drugs and
    Cosmetics Act, 1940).
  • -Devices notified from time to time under sub-clause (iv), of clause (b) of section 3 of the Act (Drugs and Cosmetics Act, 1940).

Medical Device Classification System

International Classification Risk Level Examples
Class A Low risk Elastic bandages, Hot water bags, Sphygmomanometer (divided into Sterile and Measuring AND Non-Sterile and Non-measuring)
Class B Low moderate risk Blood glucose monitoring devices, Nebulizers, Wheelchairs.
Class C Moderate high risk X-Ray machines, Infusion pumps, MRI machines.
Class D High risk Heart valves, Implanted pacemakers, Artificial joints.

Regulatory Approval Process

Classification

Approval procedure

Class A

Class B

Class C

Class D
  • The applicant should appoint an authorized representative in India (Indian Authorized Agent).
  • All the medical devices should be registered with CDSCO to get approval.
  • The application can be made online using SUGAM portal or in hard copy. It should accompany all the requisite documents along with the fees.
  • For Class A or Class B medical devices, one must submit an application to the State Licensing Authority for a license or loan license to manufacture for sale or for distribution.
Type Application Form License Form
License MD-3 MD-5
Loan License MD-4 MD-6

 

  • For Class C or Class D medical devices, one must submit an application to the Central Licensing Authority for a license or loan license to manufacture for sale or for distribution.
Type Application Form License Form
License MD-7 MD-9
Loan License MD-8 MD-10

Note: Loan license means a license issued for manufacturing a medical device by the State Licensing Authority or the Central Licensing Authority, as the case may be, to a person who intends to utilize the manufacturing site of another licensee for manufacturing the same medical device as manufactured by the licensee at that site.

Additional Information

Approval timeline

Class A:

  • Grant of License by SLA – 45 days
  • Audit of the manufacturing site from the date of issue of license – 120 days

Class B:

  • Audit of the manufacturing site from the date of application – 90 days
  • Inspection report submitted to SLA – 30 days
  • Grant of License by SLA – 20 days

Class C and Class D:

  • Completion of the scrutiny from the date of application – 45 days
  • Audit of the manufacturing site from the date of application – 60 days
  • Grant of License from the date of audit report – 45 days

License validity period

Does not expire if the license retention fee is paid (every 5 years)

Fees

Class A or Class B:

  • One Site – 5000 INR
  • Each Distinct Medical Device – 500 INR

Class C or Class D:

  • One Site – 50000 INR
  • Each Distinct Medical Device – 1000 INR

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