Executive Summary:
The Ministry of Health and Family Welfare addresses questions regarding the regulation of medical devices in India. It details the establishment of a separate medical device vertical within the CDSCO, the strengthening of post-market surveillance, the regulation of Software as a Medical Device (SaMD), the consideration of value-based procurement, and GST rates on medical devices. The Materiovigilance Programme of India (MvPI) was set up in 2015 to monitor the safety of medical devices, and Health Technology Assessment India (HTAIn) was approved in May 2023.
Key Points / Main Content:
Regulatory Authority:
* A separate medical device vertical has been created under the Central Drugs Standard Control Organization (CDSCO) to specifically regulate medical devices.
Post-Market Surveillance:
* The Materiovigilance Programme of India (MvPI) was established in 2015 to monitor medical device safety.
* There are 596 functional Medical Device Adverse Event Monitoring Centres (MDMCs) across the country.
* The Indian Pharmacopoeia Commission (IPC) is the National Coordination Centre (NCC) for MvPI.
* A comprehensive guidance document assists in identifying and reporting adverse events.
* The Adverse Drug Monitoring System (ADRMS) Online Portal facilitates electronic reporting of adverse events.
* Medical Devices Rules, 2017, require applicants to submit Periodic Safety Update Reports (PSURs).
* Post Marketing Surveillance is monitored by the CDSCO as per Medical Devices Rules 2017.
Software as a Medical Device (SaMD):
* Software falling under the medical device definition (S.O. 648(E) dated 11.02.2020) is regulated under the Medical Devices Rules, 2017.
Value-Based Procurement and Health Technology Assessment:
* Health Technology Assessment India (HTAIn) was approved in May 2023 to evaluate the cost-effectiveness of health technologies.
* HTAIn provides recommendations for procurement, new technology introduction, and health programs.
* 98 studies have been approved.
GST on Medical Devices:
* Most medical devices attract a GST rate of 12%.
* GST rates are prescribed based on the recommendations of the GST Council.
* A Group of Ministers (GoM) was constituted on 17th September 2021 to review and recommend rationalization measures for GST rates.
Impact Analysis:
Medical Device Manufacturers/Applicants:
* Impact: Must comply with Medical Devices Rules, 2017, including submission of Periodic Safety Update Reports (PSURs).
* Action Required: Implement post-market surveillance and reporting systems; adhere to regulatory standards for SaMD.
Hospitals and Healthcare Professionals:
* Impact: Play a crucial role in reporting adverse events related to medical devices.
* Action Required: Utilize the MvPI guidance and ADRMS Online Portal to report adverse events.
Patients/Consumers:
* Impact: Benefit from enhanced post-market surveillance and safer medical devices.
* Action Required: Report any adverse events experienced with medical devices to healthcare providers.
Government (Ministry of Health and Family Welfare, CDSCO, IPC, HTAIn):
* Impact: Responsible for implementing and overseeing the regulatory framework for medical devices.
* Action Required: Continue to strengthen post-market surveillance, refine regulations for SaMD, and promote value-based procurement.
GST Council/Department of Revenue:
* Impact: Responsible for determining GST rates on medical devices.
* Action Required: Consider rationalizing GST rates to improve affordability, especially for critical diagnostics and implants.
Key Entities Referenced
Central Drugs Standard Control Organization CDSCO: The central drug regulatory authority in India, responsible for regulating pharmaceuticals and medical devices.
Medical Devices Rules, 2017: The regulatory framework governing medical devices in India, outlining requirements for manufacturing, import, sale, and distribution.
Materiovigilance Programme of India MvPI: A program initiated by the Ministry of Health and Family Welfare to monitor the safety and performance of medical devices in India through adverse event reporting.
Indian Pharmacopoeia Commission IPC: The National Coordination Centre NCC for the Materiovigilance Programme of India, responsible for coordinating adverse event monitoring activities.
Medical Device Adverse Event Monitoring Centres MDMCs: Centers located across India responsible for reporting adverse events related to medical devices as part of the Materiovigilance Programme of India.
Health Technology Assessment India HTAIn: An attached office in Department of Health Research that evaluates the cost-effectiveness and appropriateness of health technologies, including medical devices.
GST Council: A constitutional body in India comprising members from States/Union Territories and the Centre, responsible for making recommendations on Goods and Services Tax (GST) rates.
Ministry of Health and Family Welfare: The government ministry responsible for public health in India.
GOVERNMENTOFINDIA
MINISTRYOFHEALTH AND FAMILYWELFARE
DEPARTMENTOFHEALTH AND FAMILYWELFARE
LOK SABHA
UNSTARREDQUESTION NO. 2216
TOBE ANSWERED ON01ST AUGUST,2025
MEDICALDEVICES REGULATORYAUTHORITY
2216.THIRU DAYANIDHIMARAN:
Will the Ministerof HEALTH AND FAMILYWELFAREbe pleasedtostate:
(a) whether the Government plans to establish an independent medical devices regulatory
authority, separate from the drug-centric Central Drugs Standard Control Organization
(CDSCO) toensure sector-specific expertise andfaster approvalsandif so, the detailsthereof;
(b) whether any steps have been taken/proposed to be takenby the Government to strengthen
post-market surveillance including the creation of a publicly accessible adverse events
database akin to the US FDA’s MAUDE or the EU’s EUDAMED and if so, the details
thereof;
(c) whether the Government considered implementing a comprehensive regulatory
framework for Software as a Medical Device (SaMD) especially AI-based diagnostics and if
so, the detailsthereof;
(d) whether the Government is likely to adopt value-based procurement and expand Health
Technology Assessments to prioritise high-impact, cost-effective devicesandif so, the details
thereof; and
(e) whether there is an intent to rationalise GST slabs on medical devices to improve
affordability,especially for criticaldiagnosticsandimplantsandif so, the detailsthereof?
ANSWER
THE MINISTER OFSTATE IN THE MINISTRYOFHEALTH AND FAMILY
WELFARE
(SMT.ANUPRIYAPATEL)
(a): A separate medical device vertical has been created under Central Drugs Standard
Control Organization (CDSCO) tospecificallyregulate medical devicesinthe country.
(b): In order to strengthen the post-market surveillance system and reporting of adverse
events/side effects for medical devices in the country, Ministry of Health & Family Welfare
has set up Materiovigilance Programme of India (MvPI) to monitor the safety of medical
devices in the country in the year 2015. The Indian Pharmacopoeia Commission (IPC) is
National Coordination Centre (NCC) for the MvPI. This is a strategic initiative launched bythe Ministry of Health& Family Welfare,Government of India. Under the said program there
are at present 596 functional Medical Device Adverse Event Monitoring Centres (MDMCs)
all over the country which is entrusted with the responsibility to report adverse events due to
the use of medicaldevices inthe country.
MvPI has issued a comprehensive guidance document to assist hospitals, healthcare
professionals, and other stakeholders in identifying and reporting adverse events associated
with medical devices. IPC has launched indigenously developed Adverse Drug Monitoring
System (ADRMS) Online Portal, an electronic tool to report the adverse events with the use
of medicaldevice.
Further, there is provision, under the Medical Devices Rules, 2017, stipulating that
subsequent to approval of a medical device, the applicant is required to submit Periodic
Safety Update Reports (PSURs) to Central Drugs Standard Control Organisation (CDSCO).
Post Marketing Surveillance including any suspected unexpected serious adverse event,
recall,Periodic SafetyUpdate Report (PSUR)are monitoredbythe CDSCO asperprovisions
mentionedinChapterIV, V,VII, VIII, XI of Medical DevicesRules2017.
(c): Softwares which fall under medical device definition as per Ministry of Health and
Family Welfare notification S.O. 648(E) dated 11.02.2020 are regulated under the provisions
of Medical DevicesRules, 2017.
(d): Health Technology Assessment India (HTAIn) was approved as an attached office in
Department of Health Research inMay 2023. The objective is to provide a health technology
assessment system that evaluates cost effectiveness andappropriateness of use of the existing
and new health technologies in healthcare services by prioritizing high impact and cost
effective Devices. It gives recommendation in use of HTA evidence in procurement,
introduction of new technologies, State health programs and Health Benefit packages. 98
studieshave beenapproved.
(e): As informed by Department of Revenue, most medical devices attract a GST rate of
12%. GST rates are prescribed on the recommendations of GST Council, which is a
constitutional body comprising members from States/UTs and Centre. In its 45th meeting of
the GST Council held on 17th September 2021, the Council constituted a Group of Ministers
(GoM ) on GSTRate Rationalization. One of the terms of reference for the GoM was review
of the current rate slab structure of GST, including special rates, and recommend
rationalization measures.
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