FORM MD-1 [Refer sub-rule (5) of rule 13] APPLICATION FOR GRANT OF CERTIFICATE OF REGISTRATION OF A NOTIFIED BODY 1. Name of applicant: 2. Nature and constitution of Body: (i.e. proprietorship, partnership including Limited Liability Partnership, private or public company, society, trust, other to be specified) 3. Corporate / registered office address including telephone number, mobile number, fax number and e-mail id: 4. Details of accreditation (self-attested copy of certificate to be attached): 5. Standards (BIS/ISO/Others) for which notified body has been accredited under rule 13: 6. Fee paid on................Rs.................receipt/challan/transaction id............... 7. Documents enclosed, as specified in the Part I of the Third Schedule of the Medical Devices Rules, 2017, duly signed by me. 8. I undertake to comply with the provisions of the Drugs and Cosmetics Act, 1940 (23 of 1940) and the Medical Devices Rules, 2017 and other terms and conditions for working as a Notified Body as may be specified from time to time. Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 207 of 248 Place:.......................... Date:........................... Signature of designated person in India (Name and designation) [To be signed digitally] FORM MD-2 [Refer sub-rule (6) of rule 13] CERTIFICATE OF REGISTRATION FOR A NOTIFIED BODY UNDER THE MEDICAL DEVICES RULES, 2017 Registration No.:.......................... 1. M/s...................................................(Name of the firm) situated at............................... (full address with telephone and e-mail) has been registered as a Notified Body of following Class A 56[(other than non-sterile and non-measuring)] and/or Class B medical devices. 2. Details of Medical device(s): SI. No. Standards for which it is registered Class of medical devices 3. This Registration is subject to the conditions as specified in the Drugs and Cosmetics Act, 1940 (23 of 1940) and the Medical Devices Rules, 2017. Place:.................................................... Central Licensing Authority Date:................................................... [To be signed digitally]