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 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
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
Section 82 in The Medical Devices Rules, 2017
82. Conditions for registration of medical device testing laboratory.
- The following conditions shall be complied with
Medical Devices Rules, 2017
36. Grant of import licence.
(1) After examination of documents furnished with the application under sub-rule (1) of rule ... specified under provisions of Chapter VII of these rules. (5) Where a medical device, is imported from countries other than those referred
Devices Rules, 2017
4. Classification of medical devices.
(1) Medical devices other than in vitro diagnostic medical devices shall be classified on the basis ... Class D. (3) The Central Licencing Authority shall, classify medical devices referred to in rule 2, based on the intended use of the device
manufacture of medical device which does not have predicate medical device, an application for grant of permission for such medical device after completion ... Fourth Schedule: Provided that the medical device which does not have predicate medical device indicated in life threatening, serious diseases or diseases of special relevance
Section 26 in The Medical Devices Rules, 2017
26. Conditions for manufacturing licence or loan licence.
- After grant of licence or loan licence in Form ... medical device has been found not conforming with the provisions specified under the Act and these rules, and on being directed
medical device, wherein the opinion of the Medical Device Officer drawing samples of such a device may not be physically practical, such large sized medical ... investigate any complaint made in writing relating to medical device to the Medical Device Officer or any other senior officer in accordance with the direction
