Regulation of Medical devices in India The Central Drugs Standard Control Organization (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) responsible for approval of manufacturing, import, conduct of clinical trials, laying down standards, sale and distribution of medical devices through Introduction 2018 8 enforcement and implementation of the Medical Devices Rules, 2017 released through Gazette of India notification G.S.R. 78(E), dated 31st January 2017 by the MoHFW, GoI. 

As per Indian Department of Health and Family Welfare notification 2020, medical device is defined as –

All devices including an instrument, apparatus, appliance, implant, material or other article, whether used alone or in combination, including a software or an accessory, intended by its manufacturer to be used specially for human beings or animals which does not achieve the primary intended action in or on human body or animals by any pharmacological or immunological or metabolic means, but which may assist in its intended function by such means for one or more of the specific purposes of ―

• (i) diagnosis, prevention, monitoring, treatment or alleviation of any disease or disorder;
• (ii) diagnosis, monitoring, treatment, alleviation or assistance for, any injury or disability;
• (iii) investigation, replacement or modification or support of the anatomy or of a physiological process;
• (iv) supporting or sustaining life;
• (v) disinfection of medical devices; and
• (vi) control of conception.

As per MDR, 2017, ‘Medical device’ means –

• 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) [all medicine for internal or external use of human beings or animals and all substances intended to be used for or in the diagnosis, treatment, mitigation or prevention of any disease or disorder in human beings or animals including preparations applied on human body for the purpose of repelling insects like mosquitoes]
• Substances including mechanical contraceptives (condoms, intrauterine devices, and tubal rings), disinfectants and insecticides notified in the Official Gazette under sub-clause (ii) [such substances (other than food) intended to affect the structure or any function of the human body or intended to be used for the destruction of vermins or insects which cause disease or disorder in human beings or animals, as may be specified from time to time by the central government],
• Devices notified from time to time under sub-clause (iv)[such devices intended for internal or external use in the diagnostics, treatment, mitigation or prevention of disease or disorder in human beings or animals, as may be specified from time to time by the Central Government], of clause (b) of section 3 of the Act;

Classification of medical devices

• Classification of Medical devices based on the risk parameters as described, namely:
  • (i) Low risk – Class A;
  • (ii) Low moderate risk- Class B;
  • (iii) Moderate high risk- Class C;
  • (iv) High risk- Class D.
• Classification of Medical devices and in-vitro diagnostic medical devices based on the intended use of the device and other parameters, where the basic principle like – Medical Device’s intended purpose of use, intended to be used in combination with another device, software which drives a device or influences the use of a device, and intended to be used solely or principally in a specific part of the body are considered. Moreover, the various parameters like- invasive, non-invasive, surgically invasive and implantable nature along with the medical devices incorporating medicinal products shall also be considered during classification of devices.

Materiovigilance Programme of India (MvPI)

Materiovigilance Programme of India (MvPI) is meant to enable safety data collection in a systematic manner so that regulatory decisions and recommendations on safe use of medical devices being used in India could be based on data generated here. The programme is meant to monitor medical device-associated adverse events (MDAE), create awareness among healthcare professionals about the importance of MDAE reporting in India and to monitor the benefit-risk profile of medical devices. It is also meant to generate independent, evidence-based recommendations on the safety of medical devices and to communicate the findings to all key stakeholders.

Objectives of MvPI India:

• To create a nation-wide system for vigilance on medical device related adverse event. Active system provide forum for encouraging adverse event reporting, proactive investigation, collecting risk-based information from global regulators and conducting reactive investigation. The database would enable data analysis in multiple ways.
• To capture and record suspected medical device adverse events like death or serious deterioration in state of health, serious injuries and disability
• To identify and analyze new signal from the reported cases both via active as well as passive surveillance
• To analyze the benefit-risk ratio/risk analysis/causality assessment of medical devices
• To generate evidence-based information on safety of medical devices and medical generate device alert to regulator/healthcare professional
• To support regulatory agencies in the decision-making process on use of medical devices
• To communicate the safety information on use of medical devices to various stakeholders with an aim to minimize the risk
• To emerge as a national centre of excellence for Materiovigilance activities
• To collaborate with other national centers for the exchange of information and data management
• To create awareness among healthcare professionals about the significance of MDAE reporting
• To provide training and consultancy support to other national Materiovigilance centers across the globe

References: https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NTU0OA==

MVPI Guidance document – IPC