Statutory Medical Institution Seal or Stamp
Form MD-19 [See sub-rule (2) of rule 42] Licence to import investigational medical device by a government ... Name of the medical device
Quantity
|- | 2. | This licence is subject to conditions prescribed in the Medical Devices Rules, 2017. |- | 3. | This licence shall, unless
body; (x) "investigational medical device" in relation to a medical device, other than in vitro diagnostic medical device, means a medical device specified in clause ... under sub-rule (4) or sub-rule (6) of rule 20, sub-rule (1) of rule 25, or sub-rule (1) of rule
Section 31 in The Medical Devices Rules, 2017
31. Test licence to manufacture for test, evaluation, clinical investigations, etc.
(1) Small quantity of Class ... made under sub-rule (1) shall also be accompanied with the following documents, namely:- (a) brief description of the medical device including intended use, material
medical device.
(1) Any person who intends to manufacture a Class A or Class B medical device including in vitro diagnostic medical device shall make ... medical device, or the Central Licensing Authority, in case of any Class of medical device, may direct a team of officers referred to in rule
Section 51 in The Medical Devices Rules, 2017
51. Application for grant of permission to conduct clinical investigation.
(1) An application for grant of permission ... pilot clinical investigation on an investigational medical device as referred to in sub-rule (1) shall be accompanied with a fee as specified
Medical Devices Rules, 2017
85. Conditions of registration.
- A registration granted under sub-rule (3) of rule 83 in Form MD-40, shall be subject ... medical device is found on test, to be not of standard quality, the person in-charge of the registered medical device testing laboratory shall furnish
Section 53 in The Medical Devices Rules, 2017
53. Conditions for permission.
- After grant of permission referred to in rule 52, the following conditions shall
days from the date the application under sub-rule (2) of rule 40. (2) The medical device for which a test licence has been granted ... date of its issue. (6) The medical devices including in vitro diagnostic medical device referred to in sub-rule (2) that are not used
Section 82 in The Medical Devices Rules, 2017
82. Conditions for registration of medical device testing laboratory.
- The following conditions shall be complied with
Section 38 in The Medical Devices Rules, 2017
38. Conditions to be complied with by Licence holder.
(1) The licencee shall comply with the following ... showing the name and quantity of the medical device; (x) the licencee shall supply the medical device for sale or offer it for sale along
