Any manufacturer or seller of medical devices in India, has to mandatorily procure a licence for the purpose of manufacturing or selling of Medical Devices in India. The process of procuring the license is involving procedural compliances. For this purpose, 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 then carries 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 to sale or manufacture of Medical Device on being satisfied that the requirements of 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.
Our experts make this elongated process smooth and hassle free while adhering to the requirements timely and rendering advise in the matter for proper documentation.