Medical Devices and Legal Compliances- India
The expanse of medicine and related aspects like medical devices is directly related to making diversifications in human health, therefore, its use and transactions are regulated under different laws in India. Accordingly, the use, trade and commerce of Medical Devices is regulated under the Drugs and Cosmetics Act, 1940, Medical Devices Rules, 2017 and other subsequent Rules as enacted by the legislation. The Rules and regulations provide legal provisions related to medical devices manufacturing in India.
What are Medical Devices?
Under Section 3 (zb) of the Medical Device Rules, 2017, a Medical Device has been defined as a substance used for in-vitro diagnosis and such substances which are used to carry out or assist in different surgical procedures.
Additionally, the amendment dated February 11, 2020 to Section 3 (b) (iv) of the Drugs and Cosmetics Act, 1940 defines Medical Devices as such devices which include but are not limited to an instrument, apparatus, appliance, implant, material or other article which is used either individually or in combination, with or without the use of any accessory, especially for human beings or animals in furtherance to carry out the following functions:
- diagnosis, prevention, monitoring, treatment or alleviation of any disease or disorder
- diagnosis, monitoring, treatment, alleviation or assistance for, any injury or disability;
- investigation, replacement or modification or support of the anatomy or of a physiological process;
- supporting or sustaining life;
- disinfection of medical devices; and
- control of conception
Registration of Medical Devices- India
Under the abovementioned laws, such Medical Devices which are listed under the said laws require mandatory registration prior to commencement of any transaction. However, for those Medical Devices which do not find place in the list, have to obtain a No Objection Certificate from the Drug Controller General of India (hereinafter referred to as ‘DGCI’). The DGCI is the concerned authority appointed by the Central Drugs Standard Control Organisation to obtain the approval regarding manufacturing of drugs and other medical devices.
Regulatory Classification of Medical Devices
As per the Medical Device Rules, 2017, the registration of Medical Devices is based on the classification of Medical Devices into four categories
- Class A – Low Risk (example: thermometers, tongue depressors)
- Class B – Low-moderate Risk (example: hypodermic needles, suction equipment)
- Class C – Moderate-high risk (example: lung ventilator, bone fixation)
- Class D – High Risk (example: heart valves, implantable devices)
License for manufacture or sale of Medical Devices- India
- An entity or a person interested in manufacture or sale of Medical Devices in India is required to make an application in respect of the said Medical Device to the State Licensing Authority along with the prescribed fees. The said application has to be accompanied with the requisite documents and undertaking as mentioned in the Medical Devices Rules, 2017.
- The State Licensing Authority will thereafter carry out the scrutiny of documents and conduct an audit along with inspection of premises, if required. Thereafter, the State Licensing Authority can either grant a license for sale or manufacture of the Medical Device on being satisfied that the requirements under the Medical Devices Rules, 2017 have been complied with, or reject such application.
Import License for Medical Devices
- An importer of a Medical Device can submit an application for obtaining license with respect to such imported Medical Device in India. In the event of import of Medical Devices, an authorized agent of such importer having either of the licences to manufacture for sale or distribution or wholesale licence for sale or distribution under the Medical Device, shall make an application for grant of import licence for medical device to the Central Licensing Authority. Upon receipt of the application, the Central Licensing Authority shall scrutinize the documents submitted and shall carry out the inspection of the overseas manufacturing premises.
The process of Medical Device registration is a simple but an elongated process. However, with the submission of required and specific documents/ information, said registration can be obtained smoothly.