Registration certificate to sell, stock, exhibit or offer for sale or distribute a medical device including in vitro diagnostic medical device.— (1) The State Licencing Authority shall appoint Licensing Authorities for the purpose of issuing registration certificate under this Part for such areas as may be specified. (2) Any person who intends to sell, stock, exhibit or offer for sale or distribute a medical device including in vitro diagnostic medical device, shall make an application in Form MD-41 to the State Licensing Authority for Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India. grant of registration certificate to sell, stock, exhibit or offer for sale or distribution. (3) The application made under sub-rule (2) shall be accompanied with (i) a fees specified in Second Schedule; (ii) self certificate of compliance with respect to Good Distribution Compliance; (iii) details of the applicant or firm including its constitution, along with identification proof, such as, Aadhar card or PAN card; (iv) documentary evidence in respect of ownership or occupancy on rental of the premises; (v) details of competent technical staff, under whose direction and supervision the sales activity of medical device shall be undertaken, who shall possess the following educational qualification and experience, namely:— (a) hold a degree from a recognized University/Institution; or (b) is a registered pharmacist; or (c)has passed intermediate examination or its equivalent examination from a recognised Board with one-year experience in dealing with sale of medical devices; (vi) brief description on other activities carried out by applicant, namely, storage of drugs, medical items, food products, stationeries, etc., or any other activities carried out by the applicant in the said premises; and (vii) an undertaking to the effect that the storage requirements to sell, stock, exhibit or offer for sale or distribute a medical device will be complied with. (4) The State Licensing Authority shall, after scrutiny of documents and on being satisfied that the requirements of these rules have been complied with, grant a registration certificate in Form MD- 42, or if not satisfied, reject the Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India. application for reasons to be recorded in writing, within ten days from the date the application is made under sub-rule (2). (5) If the application for grant of registration certificate to sell, stock, exhibit or offer for sale or distribute a medical device is rejected under sub-rule (4), the aggrieved person may prefer an appeal before the State Government within forty-five days from the date of receipt of such rejection, which may, after such enquiry and after giving an opportunity of being heard to the appellant, dispose it within a period of sixty days from the date of receipt of such appeal.