Medical Devices in India are directed as drugs by the Central Drugs Standard Control Organization (CDSCO). CDSCO under Directorate General of Health Services in Ministry of Health and Family Welfare (MoHFW), Government of India (GoI) is the National Regulatory Authority (NRA) effective for permission of manufacturing, import, the conduct of clinical trials, setting down standards, selling and distribution of medical devices.
Central Government appoints the Drugs Controller General of India recognized as Central Licensing Authority. License for import of investigational medical materials by Government hospital or sanctioned medical institution for treatment of patients is given by Central Licensing Authority.
Medical devices mean “All devices including an instrument, implant, appliance, apparatus, material or another article, whether used alone or in combination, including software or an accessory, intended by its manufacturer to be utilized especially for human beings or animals which does not perform the primary proposed action in or on human body or animals by any pharmacological or immunological or metabolic means, but which may help in its designated function by such means for one or more of the particular purposes of-
prevention, diagnosis, monitoring, treatment, or alleviation of any disease or disorder;
diagnosis, treatment, monitoring, alleviation, or assistance for, any injury or disability;
replacement investigation, or modification or support of the anatomy of a physiological method;
supporting or comforting life;
disinfection of medical appliances; and
handle of perception”
Moreover, investigational medical devices about medical devices, other than in vitro diagnostic medical device, suggests a piece of medical equipment which does not have its word device. Import of investigational medical tools is important for the government hospital as it gives the hospital or other sanctioned bodies with the extended grown equipment that could be boon for persons suffering from a life-threatening condition or disease-causing serious permanent injury or disease needing therapy for unmet medical need. Import is an essential idea for which the Government has accused some customs and import necessity be done according to such laws. There are many medical tools for which the import has been banned by the government but there are systems to get such things by Government hospitals or statutory bodies for the treatment of patients.
Import of investigational medical equipment by Government hospital or legal medical institution for treatment of the patient may be permitted only after given by the Central Licensing Authority even though the import of such investigational medical equipment is banned in India, but allowed in the country of origin. A small number of the investigational medical device may be permitted to be implied by the Central Licensing Authority for treatment of a patient suffering from a life-endangering disease or disease-causing dangerous permanent injury or disease needing therapy for unmet medical need on an application. Such an application must be prepared by a Medical Officer for the superintendent of a Government hospital or a statutory medical institution in Form MD-18. Such an application has to be followed by Technical files and Security and performance data generated in the country of origin with a fee of Rs.500/- for a various distinct medical device. Checklist for such certificates needed contains Covering letter, use in Form MD-18 with a certificate of Medical Superintendent of the Government Hospital / Head of Statutory Medical Institution, Features of Medical Device, Labels and IFU, whether it is for patients suffering from a life-threatening infection or disease-causing dangerous continuing weakness or disease requiring therapy for unmet medical need, Regulatory Permission certificates in the country of origin, the justification for the amount intended to be imported. When application filed by Government hospital or statutory bodies in Form MD-18 for a small number of products for life-threatening or disease needing therapies is followed with conformation to Quality Management System and product allowed in the country of origin, data is analyzed by regulators and thereafter License is given for the treatment of a patient in Form MD-19, when satisfied. The term considered ‘small quantity’ may be transformed into a larger amount. Where the Central Licensing Authority is satisfied, it may, in unusual and special circumstances, allow the import of a larger number of medical devices for treatment by the patient. The amount deemed required shall be decided by the Central Licensing Authority after getting into account the support of the hospital treated for treatment of a patient suffering from a life advancing disease or disease-causing grave permanent injury or illness needing therapy for unmet medical need. It is to be offered through the online Sugam Portal of the CDSCO online registration, on Corpseed a source document for online submission of the statement has also been added for source by the medical device management. Online Portal for Medical devices enables the applicant to present online applications for the Medical Devices regulatory method to CDSCO. It also enables the upload of preserving documents, reply to doubts from CDSCO officials, and follow their application status. The user account lists out all the applications presented and licenses/permits held by them and provides the statistical analysis of the applications for different methods and licenses assigned, suspended/cancelled, and withdrawn. Form MD-18 can be filed at CDSCO online registration is ‘Online System for Medical Devices’ by Central Drugs Standard Control Organization, there are all the advantages of uploading needed documents and payment of fee as well. A checklist has also been given there with the possibility of holding a submitted application whether denied or accepted, everything is presented at this portal and has been made very easy, the offering of application.
To obtain a license for the import of investigational medical devices by a Government hospital or legal institution for the treatment of patients, all documents must be provided and uploaded with the demanded fee. It has been given timely and easy for applying. It has been done to avoid the trouble for the legal foundation appealing for the license. Rights and responsibilities go hand in hand. When a right has been given for the import of medical tools, some duties or responsibilities are supposed from the license holder. That the permission granted, shall be used particularly for the treatment of the patient suffering from a life threatening illness or disease-causing dangerous permanent injury or disease needing treatment for unmet medical need. Different is that the owner of the license shall keep a record of the name of the company, quantity imported and done, date of import, name, and address of the patient, and diagnosis. That the holder of the license shall provide the medical equipment officer approved by the Central Licensing Authority in this behalf to enter, with or without prior notice, the bases where the medical tools are stocked and to examine the premises and important records and review how the medical device is being used and to take if required, samples thereof. The license holder must comply with the Central Licensing Authority by the method of determining these duties and providing every true and right document at the time of uploading documents and at the time when the medical device officer comes to investigate the premises. The consignment of a medical device shall be followed by an invoice or a receipt showing the name and quantity of the medical equipment.
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