Good Manufacturing Practice in Indian context
Pharmaceutical Regulations in India
The application for the manufacturing of small quantities of Class A or Class B or Class C or Class D of medical devices for the purpose of clinical investigations, test, evaluation, examination, demonstration or training shall be made in Form MD-12 to the Central Licensing Authority along with a fee as specified in the Second …
Continue reading “Test Licence for Manufacturing Medical Devices”
The manufacturing or testing activity should be performed only under the supervision of the competent technical staff and at least one unit of sample from each batch of invasive medical device and in vitro diagnostic medical device should be maintained for 180 days after the expiry date. If applicable the medical device should be accompanied …
Continue reading “Conditions for manufacturing or loan licence”
Any person who intends to manufacture Class C or Class D medical device may apply to the central licensing authority through the online portal of Central Government in Form MD-7 (for licence) or MD-8 (loan licence) along with the required fees as specified in the second schedule and documents as specified in clause (ii) of …
Continue reading “Manufacturing Licence for Class C or Class D Medical Device”
Any person who intends to manufacture Class A or Class B medical device including the in vitro diagnostic medical device must apply to the state licensing authority through the online portal of Central Government in Form MD-3 (for licence) or MD-4 (loan licence) along with the required fees as specified in the second schedule and documents as specified in Part-II of the fourth schedule. The application should also accompanied by an undertaking that it complies with the Quality Management System, as specified in the Fifth Schedule
Chapter – III
Authorities, Officers and Bodies
In India, depending on the class, the medical devices are regulated by Central Licensing Authority and State Licensing Authority
Central Licensing Authority
The central licensing authority is the competent authority for the enforcement of these rules in relation to:
1. Import of all classes of medical devices
2. Manufacture of Class C and D medical devices
3. Clinical investigation and approval of medical devices
4. Clinical performance evaluation and approval of new in vitro diagnostic medical devices, and
5. Co-ordination with state licensing authorities
Based on the intended use and other parameters, the Medical devices (in vitro diagnostic and other than in vitro diagnostic) are classified into the following four groups by the Central Licensing Authority and the class wise lists are published in the website of CDSCO
Medical devices are defined under section 3, clause (b) of the Drugs and Cosmetics Act, 1940, along with drugs. It should be read with Rule 3 (zb) of the Medical Devices Rules 2017. Medical devices include both the substances (excluding drugs) and the devices which are notified and used for the medical purposes.