The consignment of medical device should be accompanied by an invoice or statement showing the name and quantity of the medical device. If applicable the medical device should be accompanied by a package insert or user manual. The licence should also be produced to the State or Central Medical Device Officer or his seniors, as the case may be.
Continue reading “Conditions for Import of Medical Devices”Import Licence – Medical Devices
An authorized agent having manufacturing or wholesale licence can apply for the import licence to the Central Licensing Authority through the online portal in Form MD-14 along with the required fees as specified in the second schedule and documents as specified in the fourth schedule. Any change in documents can be informed in writing before the grant of licence. Any subsequent application for licence for additional manufacturing site for the same medical device or additional medical device manufactured at the same manufacturing site shall be made by the same authorized agent along with the required fees as specified in the second schedule and documents as specified in the fourth schedule
Continue reading “Import Licence – Medical Devices”Test Licence for Manufacturing Medical Devices
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 Schedule. A description of the medical device including its design, material of construction, intended use, along with the list of equipment and qualified persons need to be provided along with the application. If the applicant possesses any manufacturing licence or approval letter for undertaking research and development activities from any Government, it needs to be provided along with the application.
Continue reading “Test Licence for Manufacturing Medical Devices”Conditions for manufacturing or loan licence
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 by a package insert or user manual. Each batch of medical device should be tested either in own laboratory or any laboratory approved under these rules. The records for manufacturing and sales should be maintained and it should be open for inspection by a Medical Device Officer. The licence should also be produced to the State or Central Medical Device Officer or his seniors, as the case may be. Inspection book in Form MD-11 should be maintained for recording of the observations made by notified body or medical device officer.
Continue reading “Conditions for manufacturing or loan licence”Manufacturing Licence for Class C or Class D Medical Device
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 Part-II of the fourth schedule. The applicant should ensure that the manufacturing site complies with the quality management system as specified under the fifth schedule and competent technical staffs for manufacturing and testing are appointed.
Continue reading “Manufacturing Licence for Class C or Class D Medical Device”Manufacture of Class A or Class B 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.
Continue reading “Manufacture of Class A or Class B Medical Device”Authorities, Officers and Bodies for Regulation of Medical Devices
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:
Continue reading “Authorities, Officers and Bodies for Regulation of Medical Devices”Classification of Medical Device
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
Continue reading “Classification of Medical Device”What is a Medical Device?
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.
Continue reading “What is a Medical Device?”