Regulatory framework of Medical devices & IVD Kits in India Dr. Ravi Kant Sharma Deputy Drugs Controller (India) Ministry of Health & Family Welfare, Government of India

Scope of the regulation Medical Device Rules,2017 are applicable to: substances used for in vitro diagnosis and surgical dressings, surgical bandages, surgical staples, surgical sutures, ligatures, blood and blood component collection bag with or without anticoagulant covered under sub-clause (i) of section 3 of the Drugs and Cosmetics Act, 1940 (23 of 1940); substances including mechanical contraceptives (condoms, intrauterine devices, tubal rings), disinfectants and insecticides notified under sub-clause (ii) of section 3 of the Drugs and Cosmetics Act, 1940 (23 of 1940); and devices notified from time to time under sub-clause (iv), of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940 (23 of 1940);

The Govt of India has notified… Name of the device Notification Number Date of notification 1 Disposable Hypodermic Syringes GSR 365 (E) 17-03-1989 2 Disposable Hypodermic Needles 3 Disposable Perfusion Sets 4 In vitro Diagnostic Devices for HIV, HbsAg and HCV GSR 601(E) 27-08-2002 5 Cardiac Stents S.O. 1468 (E) 06-10-2005 6 Drug Eluting Stents 7 Catheters 8 Intra Ocular Lenses 9 I.V. Cannulae 10 Bone Cements 11 Heart Valves 12 Scalp Vein Set 13 Orthopedic Implants 14 Internal Prosthetic Replacements 15 Ablation Devices S.O.237(E) 25.01.2016

Medical Device Rules,2017 Content Chapter- I Title, Application, Commencement, Definition Chapter - II Classification of MD, Grouping of MD, Essentials Principles Chapter - III Authorities, delegation of powers, Notified bodies, Medical Devices Testing Centres, Chapter - IV Manufacture of MD-Application, Inspection, grant of lic, conditions of lic, Suspension, Cancellation, Appeal, Test License Chapter - V Import of MD-Application, Overseas Inspection, grant of lic, Test lic, Hospital use, Personal use Chapter - VI Labelling requirement Chapter - VII Clinical Investigation- Permission, Medical management, Compensation, Inspection Chapter - VIII Permission to import or manufacture medical device which does not have predicate medical device Chapter -IX Duties and Powers of Medical Device Officer, Medical Device Testing Officer and Notified Body Chapter -X Regulation of Laboratories for carrying test or evaluation Chapter - XI Sale of Medical Devices Chapter - XII Miscellaneous – Rejection of application, Debarment of applicant, Exemptions

Requirements for import of Medical Devices and IVDs Application in form MD-14 Import license fee Device master file Plant master file Undertaking from authorized agent Power of attorney Regulatory requirements ISO 13485 Full Quality assurance Device design certificate Document of Conformity Marketing Approval in Country of Origin Marketing Approval in other major countries

Post Approval Changes Major changes- material of construction, design, intended use, method of sterilization, approved Shelf life and stability of the medical device, primary packaging material. the name or address of,- (i) the domestic manufacturer or its manufacturing site; (ii) overseas manufacturer or its manufacturing site (for import only); (iii) authorised agent (for import only); label excluding change in font size, font type, color, label design; manufacturing process, equipment or testing which shall affect quality of the device; Prior approval from Competent Authority. Minor Changes: design which shall not affect quality in respect of its specifications, indication for use; in the manufacturing process, equipment, or testing which shall not affect quality. packaging specifications excluding primary packaging material. Inform to Competent Authority within 30 days.

Exemptions Class A devices are exempted from Clinical Investigation. Custom made devices are exempted from provisions of import and manufacture. All provisions of Chapter V for the import of small quantity of medical devices donated to a charitable hospital for treatment of patients free of cost by that hospital, subject to the condition that the applicant has to obtain NOC from Central Licensing Authority.

Initiatives New SUGAM portal is functional for post approval changes, registration of medical devices testing laboratories , clinical investigation etc. A license shall remain in perpetuity subject to payment of retention fee. Classification of Medical Devices and IVDs uploaded in website. Medical device online portal is functional for the registration of Notified Bodies. Four notified bodies have been registered. Grouping of Medical Devices and IVDs along with essential principle checklist has been finalized uploaded in the CDSCO website. Notification of Medical Device Officer and Medical Device Testing Laboratories have been published. Availability of Viral load test for HIV, HCV & HBV Kits at NIB, Noida Guidance on Performance Evaluation of In-vitro Diagnostic Medical Devices have been published on the website .

Initiatives MOHFW vide S.O. 2237 dated 01.06.2018 designated following laboratories as Central Medical Device Testing Laboratory for carrying out test and evaluation of medical devices. S. No. Name of Laboratory Category of medical device 1 The National Institute of Biologicals, Noida In-Vitro Diagnostics for human Immunodeficiency virus, Hepatitis B Surface Antigen and Hepatitis C Virus, Blood Grouping sera, Glucose Test Strip, Fully Automated Analyser Based Glucose Reagent 2 The Central Drugs Testing laboratory, Chennai Condoms 3 The Central Drugs Laboratory, Kolkata Surgical Dressings, Surgical Cotton, Surgical Bandages, Disinfectant 4 The Regional Drugs Testing Laboratory (RDTL), Guwahati Disposable Hypodermic Syringes, Disposable Hypodermic Needle, Disposable Perfusion Sets, I.V. Cannulae 5 The Central Drugs Testing Laboratory, Mumbai Intra Uterine Devices (IUD) and Falope Rings

Initiatives CDSCO organised workshops to impart trainings to State Licensing Authorities i.e. Delhi, Rajasthan, Maharashtra, Gujarat, etc., and stakeholders for the effective implementation of Medical Devices Rules, 2017. For addressing various questions on regulatory practices in medical devices, Frequently Asked Questions (FAQ) on medical devices and in vitro diagnostics is uploaded on CDSCO website. Also regular interactions are taking place with all the stakeholders to resolve their regulatory practices issues. Setting up of Public Relation Office at CDSCO (HQ) will act as single window to guide, assist and providing information to the innovators regarding regulatory requirements. Function from 10:00 AM to 5.30 PM in all working days. Email : startupinnov@cdsco.nic.in

Awareness Central Govt vide G.S.R 432(E) & 433(E) dated 07/06/2012 prohibit Import, manufacture, sale, distribution and use of "Serodiagnostic test kits for diagnosis of tuberculosis“. Central Govt vide S.O 1352(E)dated 23/03/2018 prohibit Antibody Detecting Rapid Diagnostic Tests for routine diagnosis of malaria’ . To notify more medical devices for regulation. A. Notification has issued for regulation of digital thermometer, blood pressure monitoring device, glucometer and nebulizer with effect from 01.01.2020. Notification of more devices is under active consideration for the devices like all implantable devices, ultrasound, X-ray, MRI,etc.,