APPLICATION FOR GRANT OF LICENCE TO MANUFACTURE FOR SALE OR FOR DISTRIBUTION OF CLASS C OR CLASS D 1. Name of applicant: 2. Nature and constitution of manufacturer: (i.e. proprietorship, partnership including Limited Liability Partnership, private or public company, society, trust, other to be specified) (i) Corporate/registered office address including telephone number, mobile number, fax number and e-mail id: (ii) Manufacturing site address including telephone number, mobile number, fax number and e-mail id: (iii) Address for correspondence: [corporate/registered office/manufacturing site] 4. Details of medical device(s) to be manufactured [Annexed]: 5. Whether substantial equivalence to a predicate device is claimed: (Yes/ No) 6. Fee paid on..................Rs....................receipt / challan / transaction id......................... Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 213 of 248 7. I have enclosed the documents as specified in the Fourth Schedule of Medical Devices Rules, 2017. 8. I hereby state and undertake that: (i) the manufacturing site is ready for audit or shall be ready for audit on...........................in accordance with the requirements of Medical Devices Rules, 2017. (ii) I shall comply with all the provisions of the Drugs and Cosmetics Act, 1940 (23 of 1940) and the Medical Devices Rules, 2017. Place:................................................ Signature Date:................................................ (Name and designation) [To be signed digitally]