**Executive Summary**
This document is a response to a parliamentary question regarding the regulation of medical devices in India, answered on December 5th, 2025. It outlines the existing regulatory framework under the Medical Devices Rules, 2017, the number of medical devices approved by the CDSCO between 2020 and 2024, and information regarding post-market surveillance activities and inspections of high-risk devices.
**Key Points / Main Content**
* **Regulatory Framework:**
* The Ministry of Health & Family Welfare has notified the Medical Devices Rules, 2017, effective from 01.01.2018, which regulate the clinical investigation, manufacture, import, sale, and distribution of medical devices.
* MDR 2017 requires medical devices to conform to standards specified by the Bureau of Indian Standards (BIS) or those notified by the Central Government. In the absence of such standards, devices must comply with ISO, IEC, other recognized pharmacopoeial standards, or the validated manufacturer's standards.
* **Approval and Regulation:**
* Import of all classes of Medical Devices (A, B, C & D) and manufacture of Class C & D devices are regulated by CDSCO.
* Manufacture of Class A & B Medical devices are regulated by State Licensing Authorities (SLAs).
* Sale and distribution of all classes of medical devices are regulated by the SLAs.
* **Medical Devices Approved by CDSCO (2020-2024):**
* Class A: 3613
* Class B: 22286
* Class C: 26096
* Class D: 6288
* **Post-Market Surveillance:**
* The Ministry of Health and Family Welfare established the Materiovigilance Programme of India (MvPI) to strengthen post-market surveillance.
* 46,593 Medical Device Adverse Events (MDAEs) were reported in the last 5 years (from 2021-22 till date).
* **CDSCO Capacity:**
* A dedicated medical device vertical has been sanctioned for CDSCO with 249 regulatory posts.
* **Inspections:**
* CDSCO conducted 1,253 audits/inspections between 2020 and 2024 for evaluating applications for manufacturing licenses of high-risk medical devices (Class C & D).
* Approval of medical devices is granted or further information is sought based on inspection findings.
**Impact Analysis**
**Stakeholder: Medical Device Manufacturers**
* **Impact**: Must adhere to Medical Devices Rules, 2017, and comply with BIS, ISO, IEC, or validated manufacturer's standards. Class C & D manufacturers face stricter regulation.
* **Action Required**: Ensure compliance with regulatory standards, apply for licenses through CDSCO or SLAs based on device classification, and prepare for inspections.
**Stakeholder: State Licensing Authorities (SLAs)**
* **Impact**: Regulate the manufacture, sale, and distribution of medical devices. Responsible for Class A & B medical device manufacturing.
* **Action Required**: Enforce Medical Devices Rules, 2017, for manufacturers, distributors, and retailers within their jurisdiction.
**Stakeholder: Patients/Consumers**
* **Impact**: Benefit from a more regulated medical device market with post-market surveillance to ensure safety and performance of devices.
* **Action Required**: Report any adverse events to the Materiovigilance Programme of India (MvPI).
**Stakeholder: Central Drugs Standard Control Organization (CDSCO)**
* **Impact**: Strengthened role in regulating medical devices, particularly high-risk devices (Class C & D).
* **Action Required**: Enforce Medical Devices Rules, 2017, conduct inspections, and grant licenses based on compliance.
Key Entities Referenced
Drugs and Cosmetics Act, 1940: The existing law under which medical devices were regulated before the introduction of Medical Devices Rules, 2017.
Medical Devices Rules, 2017: The regulations notified by the Ministry of Health & Family Welfare to comprehensively regulate the import, manufacture, sale, and distribution of medical devices based on risk-based criteria.
Central Drugs Standard Control Organization (CDSCO): The regulatory body responsible for approving medical devices, regulating import, and manufacture of Class C & D Medical Devices.
Ministry of Health and Family Welfare: The ministry responsible for formulating and implementing policies related to medical devices.
Materiovigilance Programme of India (MvPI): A program established by the Ministry of Health and Family Welfare to strengthen post-market surveillance of medical devices.
GOVERNMENTOFINDIA
MINISTRYOFHEALTH AND FAMILYWELFARE
DEPARTMENTOFHEALTH AND FAMILYWELFARE
LOK SABHA
UNSTARREDQUESTION NO. 991
TOBE ANSWERED ON05TH DECEMBER, 2025
REGULATION OFMEDICALDEVICES
991.SHRIG LAKSHMINARAYANA:
Will the Ministerof HEALTH AND FAMILYWELFAREbe pleasedtostate:
(a)whether the existing legalandregulatoryframework governingmedicaldevices, including
classification, approvals, quality control and post-market surveillance, it aligns with global
standards such as United States Food and Drug Administration (USFDA) or European Union
Medical Device Regulation (EUMDR) andif so, the detailsthereof;
(b) the number of medical devicesapproved by Central Drugs Standard Control Organization
(CDSCO) during the last five years, risk-classification-wise;
(c)the numberof adverse events, safety complaintsandproduct recallsreported;
(d) whether the Government proposes to introduce a standalone Medical Devices Act,
separate from the Drugs and Cosmetics Act and its key features and timelines and if so, the
detailsthereof;
(e) the current staffing strength and technical capacity of Central Drugs Standard Control
Organization (CDSCO) toregulate medicaldevices;
(f) whether expansion or creation of a dedicated medical device regulatoris being considered
andif so, the detailsthereof; and
(g) the number and outcomes of inspections or audits conducted on high-risk devices such as
implants, ventilatorsand diagnostics during the last five years?
ANSWER
THE MINISTER OFSTATE IN THE MINISTRYOFHEALTH AND FAMILY
WELFARE
(SMT.ANUPRIYAPATEL)
(a)to(f): To have a comprehensive regulatory provisions for import, manufacture, sale
and distribution of medical devices based on risk based criteria, the Ministry of Health &
Family Welfare, Government of India has notified the Medical Devices Rules, 2017 vide
G.S.R. 78(E) dated 31.01.2017 under the provisions of the Drugs and Cosmetics Act, 1940.
Said rules are effective from 01.01.2018 to regulate the clinical investigation, manufacture,
import,sale anddistribution of the medicaldevicesinthe country.Under MDR 2017, the medical devices are requiredto conform to standards specified
by the Bureau of Indian Standards (BIS) or those notified by the Central Government. In the
absence of such standards, devices must comply with standards of the International
Organization forStandardization (ISO),the InternationalElectrotechnicalCommission (IEC),
or other recognized pharmacopoeial standard or the validated manufacturer’s standards,
wherever applicable.
Under the rules, import of all classes of Medical Devices (Class A, B, C & D) as well
as manufacture of Class C & D Medical Devices are regulated by CDSCO, while
manufacture of Class A& B Medical devices are regulated by the concerned State Licensing
Authorities (SLA) appointed by the State Governments. However, sale and distribution of all
classes of Medical Devices are regulated by the SLAs. The number of medical devices
approved by the Central Drugs Standard Control Organization (CDSCO) during the last five
years(from 2020till date)isasunder:
ClassA ClassB ClassC ClassD
3613 22286 26096 6288
To strengthen post-market surveillance of medical devices, the Ministry of Health and
Family Welfare established the Materiovigilance Programme of India (MvPI) with Indian
Pharmacopoeia Commission (IPC) as its National Coordination Centre. Under the said
Programme, in last 5 years (from 2021-22 till date), a total of 46,593 Medical Device
Adverse Events(MDAEs) have beenreported.
A dedicated medical device vertical has been sanctioned for CDSCO with 249
regulatoryposts.
(g): CDSCO has conducted 1,253 audits/inspections between 2020 and 2024 for
evaluating applications for manufacturing licences of high-risk medical devices (Class C &
D), and based on inspection findings, approval of medical devices is granted or further
informationissought.
*******