The regulation of Medical devices and In vitro diagnostic device (IVDs) in India are managed by the Drug Controller General of India (DCGI) which is within the Central Drugs Standard Control Organization (CDSCO). The regulatory structure for medical devices and In vitro diagnostic device (IVDs) is established on drug regulations under the Drugs and Cosmetics Act, 1940and Rules of the Drugs and Cosmetics 1945 (D&C Rules), in addition to the Medical Device Rules, 2017 (MDR-17).
The importance of medical devices is becoming more significant in the sector of medicine and health care. In vitro diagnostic devices are medical devices used in-vitro for conducting tests on samples like blood, urine, diagnosing a medical condition, body tissues taken to detect infections from the human body, preventing diseases, etc.
Guidelines on In-Vitro Diagnosis Kit Usage
The CDSCO have currently ‘Notified’ only certain devices that are subject to registration. All the products qualifying the definition of a medical device are lawfully subject to this regulation. With the outbreak of COVID-19 pandemic there were high demands for IVD test kits, drugs, hand sanitizer, vaccines and surgical disinfectants and these have been put on an urgent priority list for CDSCO and have been expedited for the concerned approvals.
The CDSCO shall provide guidance on such regulations and few details are as given below:-
- Any firm can directly approach DCG (I) through Public Relations Office if they have In-vitro Diagnostic Kit under development for Covid-19 diagnosis for seeking guidance for regulatory pathway.
- Any firm in any other country can directly approach DCG (I) through Public Relations Office having In-vitro Diagnostic Kit already approved for Covid-19 diagnosis regarding expedited review and approval for marketing in India.
- Depending upon the type & nature of the diagnostic kit and the existing data on the product and the evidence of available clinical performance the data requirement for clinical performance evaluation may be deferred or waived.
- Applications to manufacture or import In-Vitro Diagnostic Kit for test and further evaluation of performance may be processed on priority basis within 7 days.
- Application to import and manufacture and for conducting performance evaluation of In-Vitro Diagnostic Kit for sale and distribution would be processed on priority through expedited approval or review.
Uses of Medical Devices
The government notified The Medical Device (Amendment) Rules, 2020 on February 11, 2020, “MDR Amendment”. The MDR Amendment has introduced two changes to the rules.
- The first is bringing a new chapter for Newly Notified Medical Devices registration by their concerned importers and manufacturers.
- The second is excluding the 37 categories of notified medical devices or already regulated devices from the necessity of registration as introduced by the new chapter.
Read our article:Know the Checklist for Documents Required For Medical Device Registration in India
Requirement of Registration
The most basic requirement of registration is:-
- The importers or manufacturers of Newly Notified Medical Devices are obligated to compulsorily have the registration of their medical devices before October 1, 2021 with the Drugs Controller General of India (“DCGI”).
- From April 1, 2020 through a committed online portal called “Online System for Medical Devices”, the DCGI will begin accepting registration applications.
- A compliance certificate with ISO-13485 is obligatory for registration of the Newly Notified Medical Device. Therefore, the manufacturer or the importer of a registered medical device shall ensure that the ISO 13485 requirements are met at all times.
- Requirement to obtain a license – it is not compulsory to have a registration number for obtaining a license. Therefore, the application for license can be made anytime after April 1, 2020 or as the DCGI may specify in future. License shall be issued by the concerned authorities to the manufacturer or the importer.
Rapid Response Regulatory Framework for Covid-19
Due to the rapid spread of covid-19 in various countries it was decided to fast track the regulatory approval process in consultation with DCGI to deal with the applications for development of vaccines, diagnostic, prophylactics and therapeutics for covid-19 as per following:-
The authorised committee of Review Committee on Genetic Manipulation (RCGM) and CDSCO was constituted to give permission for import or exchange and to examine the applications for approvals.
Device Types and Eligibility Criteria
The CDSCO is creating a Corona virus unit to deal with inquiries on the progress of these products. Only notified devices will have to subject itself under the regulation by CDSCO and the other devices can be sold in India and imported by merely complying with the universal customs requirement. The given below is the list which focuses on the regulatory status under the COVID-19 critical care devices condition.
|Device type||Regulatory status|
|Facemasks/respirators||Registration not required|
|Ventilators||Registration not required|
|Dialysis/infiltration machines and consumables*||Registration not required|
|Dialysis solution||Registration required|
|Endotracheal tubes||Registration required|
|Non-invasive ventilators (bipap) machines||Registration not required|
|Gowns, gloves||Registration not required|
|Oxygen masks (venturi masks)||Registration not required|
|Central lines||Registration not required|
|Arterial lines||Registration not required|
|Vascular catheters||Registration required|
|IVD test kits||Registration required|
The devices with the requirement of registration shall be mandatorily registered and shall abide with the CDSCO.
The CDSCO has released guidelines for validation and batch testing for Covid-19 diagnostic kits along with the Centres approved to provide validation and batch testing of kits for covid-19. With the spread of corona virus the CDSCO has regulated many medical devices and In-Vitro diagnostic devices usage in India and the same has been successfully proved now.
Read our article:Regulation for all Medical Devices under CDSCO Directive