Image


What are medical devices?

Medical devices as per the Medical Devices Rules, 2017 are an umbrella term that includes meaning those devices which are used for in vitro diagnosis and constitutes surgical accessories and associated types of equipment like dressing, bandages, staples, and sutures. It also includes disinfectants, all the mechanical contraceptives like intrauterine devices, insecticides, and all the other devices which are notified by the central government in the official gazette on a timely basis.


Medical devices: application for manufacturing

  1. For Class A or Class B medical devices:
  2. In order to apply for the loan license or granting of a license for manufacturing medical devices for the purpose of sale and distribution, an application needs to be submitted to the state licensing authority. The devices eligible under such application include Class A and Class B or in-vitro medical devices. Form MD-3 must be employed for grant of license and Form MD-4 must be employed for loan license, both must be submitted together with the fees and made through an online portal.
  3. The application must be submitted along with the undertaking assuring that the criterion of the Quality management system has been fulfilled. After due verification and scrutiny, the state licensing Authority would issue a license in Form MD-5 to manufacture class A medical devices or issue a loan license in Form MD-6. The state licensing authority holds the discretion to even reject the application.
  4. For class D or class C medical devices:
  5. An application to manufacture class C or class D medical devices for the purpose of sale and distribution must be made to the Central Licensing Authority through an online portal. The application for grant of the license must be made in Form MD-7 and the application for loan license must be made in Form MD-8.
  6. The application must be tagged along with the requisite fees and prescribed documents.
  7. The central licensing authority can at any time make use of the services of an expert for the purpose of scrutinizing the documents that are technical in nature.

Manufacturing medical devices: Requirements

The outlined requirements must be met by the applicant for grant of manufacturing medical device import license or loan license. The criterion of the quality management system must be complied with by the manufacturing site. Also, competent technical staff must be appointed for supervising the manufacturing activity of the medical device.

Grant of manufacturing license

On receipt of the inspection report, the central licensing authority on being satisfied after conducting necessary inquiries shall grant the license in Form MD-9 or the loan license would be issued in Form MD-10. The application can also be rejected by the authority.

Manufacturing license: conditions

Given conditions must be complied by the holder of the license:

  1. On request of the medical device officer, the license must be produced as and when required.
  2. The license holder holds the responsibility to report to the state or central licensing authority about the occurrence of an adverse event.
  3. Approval must be obtained by the license holder on a prior basis from the licensing authority.
  4. Information about any minor change must be informed by the license holder to the licensing authority.
  5. The inspection book must be maintained by the license holder in Form MD-11.

Medical devices: import license

  1. Application

In order to obtain an import license, an application must be made by an authorized agent who has the license to manufacture a medical device to the Central licensing authority in Form MD-14. Requisite fees and prescribed documents must be tagged along with the application.

  1. Grant of import license

On being satisfied that all the necessary compliance have been made and after due verification and inquiry, the central licensing authority shall grant the license to import medical devices in Form MD-15. The application can also be rejected by the authority for any requisite reason as recorded in writing. In case the application gets rejected, then the appeal can be made by the applicant to the central government.

  1. Validity

Unless canceled or surrendered, the license shall stand valid in perpetuity.

  1. Conditions
  2. On request by the Medical device officer, the licensee holds the responsibility to produce the license as and when required.
  3. If any administrative action has taken place by virtue of any adverse reaction, then the licensee must report to the licensing authority.

Conditions

The procedure with regards to the requisite license to manufacture and import medical devices has been enumerated under the Medical Devices Rules, 2017.