APPLICATION FOR GRANT OF LICENCE TO MANUFACTURE FOR SALE AND DISTRIBUTION OF CLASS A 57[(OTHER THAN NON-STERILE AND NON-MEASURING)] OR CLASS B MEDICAL DEVICE 1. Name of applicant: 2. Nature and constitution of manufacturer: Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 208 of 248 (i.e. proprietorship, partnership including Limited Liability Partnership, private or public company, society, trust, other to be specified) 3. (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.................... 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]