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The Medical Devices Rules, 2017 which was recently notified by the Union Health Ministry has made the Central Licensing Authority (CLA) as the competent authority for providing licence for manufacture of Class C and Class D medical devices; while State Licensing Authorities have been given the authority to licence Class A or Class B medical devices.
As per the newly notified Rules, medical devices of low risk have been classified as Class A; low to moderate risk as Class B; moderate to high risk as Class C; and high risk as Class D.
According to the new Rules, which will come into force from January 1, 2018, the Central Licensing Authority shall be the competent authority for enforcement of these rules in matters relating to import of all Classes of medical devices; manufacture of Class C and Class D medical devices; clinical investigation and approval of investigational medical devices; clinical performance evaluation and approval of new in vitro diagnostic medical devices; and co-ordination with the State Licensing Authorities.
The State Drugs Controller, by whatever name called, shall be the State Licensing Authority and shall be the competent authority for enforcement of these rules in matters relating to manufacture for sale or distribution of Class A or Class B medical devices; and sale, stock, exhibit or offer for sale or distribution of medical devices of all classes.
As per the new Rules, the Central Licensing Authority may, with the prior approval of the Central Government, by an order in writing, delegate all or any of its powers to any other officer of the Central Drugs Standard Control Organisation not below the rank of Assistant Drugs Controller. The officer to whom the powers have been delegated under sub-rule (1) shall exercise the powers of the Central Licensing Authority under its name and seal.
Likewise, the State Licensing Authority may, with the prior approval of the State Government, by an order in writing, delegate all or any of its powers to any officer under its control. The officer to whom the powers have been delegated under sub-rule (3) shall exercise the powers of the State Licensing Authority under its name and seal.
Any officer not below the rank of Assistant Drugs Controller, by whatever name called, shall be the controlling officer to supervise and give instructions to any officer subordinate to such controlling officer to exercise powers and functions under these rules for areas and purposes specified, by an order, of the Drugs Controller General of India or the Drugs Controller, by whatever name called, of the State concerned, as per the new Rules.
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