**Policy Summary: Implementation of Licensing Regime for Class A and Class B Medical Devices**
This notice, issued by the Director General of Health Services, Central Drugs Standard Control Organisation (CDSCO), Ministry of Health and Family Welfare, Government of India, clarifies the implementation of the licensing regime for non-notified Class A and Class B medical devices, effective October 1, 2022, as per notification No. G.S.R. 102E dated February 11, 2020.
The notice addresses the issue of entities issuing quality certificates to manufacturers outside the purview of the Medical Devices Rules (MDR), 2017, causing confusion regarding the prescribed regulatory pathway for licensure. It explicitly states that such certificates are not a substitute for the mandatory licensure granted under MDR, 2017. Manufacturers are required to comply with licensing requirements and obtain licenses as per MDR, 2017.
Manufacturers of Class A and Class B medical devices are advised to apply for manufacturing licenses through the CDSCO's online portal (tips.cdsco online gov inNewMedDevHomepage). State Licensing Authorities (SLAs) will grant licenses following application review and audits, adhering to the timelines stipulated in MDR, 2017.
This notice reinforces a previous communication (No. 29Misc032022 DC 94 dated April 25, 2022) urging SLAs to expedite the processing of applications to prevent disruptions in the supply of these devices.
The notice is addressed to all SLAs, relevant associations, the CDSCO website, the Quality Council of India, and the Department of Pharmaceuticals.
Key Entities Referenced
Central Drugs Standard Control Organisation: A national regulatory body in India responsible for the regulation of pharmaceuticals and medical devices.
G.S.R. 102E: A notification number pertaining to regulations regarding medical devices in India.
Class A medical devices: A category of medical devices based on risk classification, requiring regulatory oversight.
Class B medical devices: A category of medical devices based on risk classification, requiring regulatory oversight.
Medical Devices Rules MDR, 2017: The regulatory framework in India governing the manufacture, import, and sale of medical devices.
State Licensing Authorities: The authorities in each state of India responsible for granting licenses for manufacturing medical devices.
Dr. V. G. Somani: Drugs Controller General of India
Quality Council of India: An autonomous organization responsible for establishing and operating national accreditation structure and promoting quality across various sectors.
File No.29/Misc/03/2022- DC (94)
Government of India
Director General of Health Services
Central Drugs Standard Control Organisation
. Date:11 July 2022
NOTICE
In pursuance of notification No. G.S.R. 102(E) dated 11.02.2020, all non-notified medical
devices of Class A & Class B categories are scheduled to enter licensing regime with effect
from 01.10.2022
A transition period of 30 months had been provided for Class A & Class B medical devices
from date of implementation of G.S.R. 102(E) i.e., 01.04.2020 for the transition to licensing
regime. During that pas the manufacturers were required to register their products on the
portal ()tips.//cdse online gov in/NewMedDev/Homepage) established for the purpose by
CDSCO and to affix the registration number on the label of such registered medical devices.
Of late, it has come to the notice of this office that some other entities are issuing quality
certificates to the manufacturers at their own level, which is becoming a source of confusion
for manufacturers vis-a-vis the prescribed regulatory pathway for obtaining the licensure for
such medical devices under Medical Devices Rules (MDR), 2017. In this regard, it is hereby
clarified that such quality certificates issued by other entities shall not be a replacement
of licensure to be granted under MDR, 2017 by the competent Licensing Authority. All
manufacturers shall have to comply with the licensing requirement and obtain the
license as per MDR, 2017, as the said rules do not recognize any such certificates which
are not mentioned in it or part of it.
Further, it is again advised that all manufacturers shall apply for obtaining manufacturing
license for Class A & Class B medical devices through CDSCO’s on-line portal so that the
manufacturing license can be granted by respective State Licensing Authorities after review
of the applications and audit (as the case may be) as per stipulated time specified in MDR,
2017 in order to avoid further delay.
In this regard this office has proactively taken up the issue vide notice No. 29/Misc/03/2022-
DC (94) dated 25.04.2022, requesting all State Licensing Authorities (SLAs) to dispose of the
applications received by them as per MDR, 2017 in time to avoid the disruption of the supply
of such devices to the patients. \
\ss-
(Dr. V. G. Somani)
Drugs Controller General (India)
To,
Oe All SLAs
All Associations
CDSCO Website
Quality Council of India
Department of Pharmaceuticals
ON