Import of medical device for personal use (1) Small quantity of medical device, the import of which is otherwise prohibited under section 10 of the Act, may be imported for personal use subject to the following conditions, namely:— (i) the medical device shall form part of a personal baggage of a passenger and be intended for the exclusive use of such passenger; (ii) the medical device shall be declared as personal baggage of the passenger to the customs authorities, if they so direct; (iii) the quantity of any single medical device so imported shall not exceed the quantity specified by the registered medical practitioner; (iv) the medical device has been prescribed by a registered medical practitioner; and (v) the medical device so imported shall be accompanied with an invoice or a statement showing the name and quantity of medical device. Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 42 of 248 (2) Small quantity of medical device, the import of which is otherwise prohibited under section 10 of the Act, and which is not forming a part of bona fide personal baggage, may be imported for personal use, on an application made by the applicant in Form MD-20 and such application shall be accompanied by documents confirming that the device is for bona fide personal use and a prescription to that effect by a registered medical practitioner. (3) On receipt of an application under sub-rule (2), the Central Licensing Authority shall, on being satisfied about the information and the documents enclosed with the application, grant permission in Form MD-21 or may reject the application for reasons to be recorded in writing within a period of seven days from the date of application under sub-rule (2). (4) Medical devices as referred to in sub-rule (2) shall be subject to the following conditions, namely:— (i) the medical device shall be declared to the Customs Authorities if they so direct; (ii) the consignment of the medical device so imported shall be accompanied with an invoice or statement showing the name and quantity of medical device.