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.
For manufacturing the competent technical staff should possess a degree in engineering or science, in relevant branch or subject, respectively, or in pharmacy and has experience of not less than two years in manufacturing or testing of medical devices; or diploma in engineering in relevant branch or in pharmacy and has experience of not less than four years in manufacturing or testing of medical devices. For testing the competent technical staff should possess a degree or diploma in engineering or science, in relevant branch or subject, respectively, or in pharmacy and has experience of not less than two years in testing of medical devices.
The scrutiny of application and technical documents may be performed by the central licensing authority within forty five days. The central licensing authority may use the services of any experts in relevant field for such scrutiny.
If the application or documents is incomplete, the central licensing authority may reject the application electronically along with the reasons. If the deficiencies are rectified by the applicant within the stipulated period, then the Central Licencing Authority may scrutiny such application within forty five days.
If the application is order, the central licensing authority may cause an inspection of the manufacturing site by a team comprising of not less than two Medical Device Officers which may include any officer senior to the Medical Device Officer with or without an expert or avail the services of a Notified Body for such inspections, if necessary. The composition of the team may be determined by the controlling officer. After the inspection, the inspection team may forward a descriptive report to the central licencing authority and the applicant through the online portal. After receipt of the report and enquiry, if required, the Central Licensing Authority may grant a licence in Form MD-9 or loan licence in Form MD-10 or reject the application with resons in wrtiting, within 45 days from the date of receipt of the inspection report. If the application is rejected the applicant may file an appeal to the Central Government within 45 days from the date of receipt of such rejection and the Central Government may dispose the appeal within a period of 60 days.
For the manufacturing of additional medical devices in the licensed manufacturing site, an application has to be made to the Central or State Licensing Authority, as appropriate, along with the fee as specified in the Second Schedule and the documents as referred to in rule 20 or rule 21. For the manufacture of investigational medical device or new in vitro diagnostic medical device, prior permission in Form MD-27 or Form MD-29 from the Central Licensing Authority is required before the grant of manufacturing license.