Manufacture of Class C, D medical devices: CDSCO makes Centre the licensing authority
New Delhi: Through a recent Gazette notification, the Central Drugs Standard Control Organisation (CDSCO) has apprised that medical device manufacturers will now have to get Loan License sanctioned by the Central Licensing Authority (CLA) instead of the State Licensing Authority(SLA) for manufacture, sale or distribution of Class C or Class D medical device.
There are various forms to be filled to obtain a license for manufacture in India based on whether it’s at one's own premise or the products are manufactured at someone else’s premise. One of the forms to be filled in for obtaining requisite licenses for medical devices include Form MD-10. Form MD- 10 is filled for obtaining license for manufacturing medical device of Class C & D using other manufacturer’s premises will be given out in this form.
Class C medical devices include Bifurcation Stent, Diagnostics Radiology Catheters, Tympanostomy Tube, Female/ male condoms, Injector Type actuator syringe, Infusion Pump, Tissue Expanders and others while Class D medical devices include Cardiac Catherization Kit, Cardiovascular Catheter, ventricular Bypass, Drug-Eluting Stents, Retinal Implant, Bone Heterograft and others.
In exercise of the powers conferred by section 12 read with section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government, after consultation with the Drugs Technical Advisory Board, replaces the terms “state licensing authority (SLA)” with “central licensing authority (CLA)”.
In this regard, the Government has amended Form MD-10 of the Medical Devices (MD) Rules, 2017.
In the Medical Devices Rules, 2017, in the Appendix, in Form MD-10, for the words “State Licensing Authority”, the words “Central Licensing Authority” shall be substituted.
This will come into effect from September 13, 2019.
The MD Rules, 2017 was published in the official gazette dated January 31, 2017, and was last amended dated April 18, 2019. MD Rules 2017 under Drugs and Cosmetics (D&C) Act is meant to regulate the manufacture, import, sale and distribution of the medical devices.