In case of Class A Medical Device, the State Licensing Authority may grant the licence in Form MD-5 or loan licence in Form MD-6 or reject the application with resons in wrtiting within 45 days from the date of application. In case of Class A medical devices, no audit of the manufacturing site is required prior to the grant of licence. The audit of the manufacturing site by the notified body, in the manner as specified in the Third Schedule, may be carried out within 120 days from the date of grant of licence.
In case of Class B medical devices the audit of the manufacturing site is carried out by the notified body, in the manner specified in the Third Schedule, within 90 days from the date of application and furnish the report to the State Licensing Authority within 30 days. The State Licensing Authority may grant the licence in Form MD-5 or loan licence in Form MD-6 or reject the application with resons in wrtiting, within 20 days from the date of receipt of report by the notified body.
If the application is rejected the applicant may file an appeal to the State Government within 45 days from the date of receipt of such rejection and the State Government may dispose the appeal within a period of 60 days. When the licensee does not conform to the standards of quality or to the provisions of Fifth Schedule, the State Licensing Authority or the Central Licensing Authority may direct a team of officers to cause inspection of licenced manufacturing site.