The New Medical Devices Rules In Drugs And Cosmetics Act, 1940
The Ministry of Health and Family Welfare has published in India’s Official Gazette on October 17, 2016, the new Medical Devices Rules in Drugs And Cosmetics Act, 1940.
The New Medical Devices rules are applicable in respect of –
1). Substances covered under sub-clause (i) of clause (b) of section 3 used for in vitro diagnosis;
2). Substances that are in the nature of mechanical devices covered under sub-clause(ii) of clause (b) of section 3;
3). Devices specified from time to time by the Central Government by notification in the Official Gazette under sub-clause (iv) of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940.
The rules focus on creating a separate registration and oversight system for medical devices and drugs. Also, theses rules define the duties and functions of the Centre Licensing Authority and State Licensing Authority.
Under the new rules-C
The medical devices manufacturers will not have to issue a separate license from the state licensing authority for the manufacturing of Class A and Class B medical devices.
The State Drug Controller is the State Licensing Authority and is the competent authority for enforcement of these rules in matters related to manufacture of Class A and Class B medical Devices.
People engaged in the manufacturing of predicate medical devices will require a separate approval from Centre Licensing Authority before applying to the State Licensing Authority.
According to these new rules medical devices are classified into 4 new classes on the basis of their functions and impact-
- The medical devices which will have low risk will fall under Class A;
- The medical devices having low moderate risk will fall under Class B;
- The medical devices having moderate high risk will fall under Class C
- And the medical devices having high risk will fall under Class D.
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