**Summary:**
This notice, issued by the Central Drugs Standard Control Organisation (CDSCO), Ministry of Health and Family Welfare, Government of India, on October 21, 2022, addresses the implementation of the Medical Devices Fifth Amendment Rules, 2022, published vide G.S.R. 754(E) dated September 30, 2022. The amendment introduces the provision for a Registration Certificate (Form MD42) as an alternative to a Drugs Sale License for entities involved in the sale, stocking, exhibition, offer for sale, or distribution of medical devices, including in vitro diagnostic medical devices, effective from September 30, 2022.
The notice acknowledges that stakeholders have reported difficulties in submitting hard copy applications for the Registration Certificate. It clarifies that applicants may apply for the grant of a Registration Certificate in Form MD41 to the concerned State Licensing Authority (SLA). The SLAs are instructed to accept these hard copy applications, process them expeditiously with priority, and ensure uninterrupted access and supply of medical devices.
The notice is addressed to all State/UTs Drugs Controllers and copied to stakeholders/associations of medical devices and in vitro diagnostics, all Zonal/Sub-Zonal offices of CDSCO, and all Port offices of CDSCO. The Drugs Controller General, Dr. V. G. Somani, issued the notice.
Key Entities Referenced
Central Drugs Standard Control Organisation: A national regulatory body in India responsible for the regulation of pharmaceuticals and medical devices.
Ministry of Health and Family Welfare: A government ministry in India responsible for public health.
Medical Devices fifth amendment Rules, 2022: An amendment to the regulations governing medical devices in India.
G.S.R 754E: A Gazette of India notification number related to the Medical Devices fifth amendment Rules, 2022.
Registration Certificate: A certificate required to sell, stock, exhibit, or offer for sale or distribute a medical device, including in vitro diagnostic medical devices in India.
Form MD41: Application form for grant of Registration Certificate.
Form MD42: Registration Certificate to sell, stock, exhibit or offer for sale or distribute a medical device.
State Licensing Authority: The licensing authority at the state level responsible for issuing Registration Certificates.
F, No. 29/Mise/03/2022-DC (269)
Central Drugs Standard Control Organisation
Government of India
Ministry of Health and Family Welfare
sie oe a ok ak ae
FDA Bhawan, New Delhi
Dated the 21' October, 2022
NOTICE
Subject: Implementation of Gazette notification vide G.S.R 754(E) dated 30.09.2022 -
Regarding.
The Ministry of Health and Family Welfare, Government of India has published Medical
Devices (fifth amendment) Rules, 2022 vide G.S.R 754(E) dated 30.09.2022, wherein
provision for Registration Certificate to sell, stock, exhibit or offer for sale or distribute a
medical device including in vitro diagnostic medical device, as alternative to Drugs Sale
License has been implemented with effect from 30.09.2022.
Various representations have been received from stakeholders, regarding implementation of
said rules stating that their application in hard copy is not being accepted. As per the said
rules, the applicant may apply for grant of Registration Certificate in Form MD-41 to the
concerned State Licensing Authority (SLA) and the SLA after satisfying the requirements
shall issue Registration Certificate in Form MD-42 to sell, stock, exhibit or offer for sale or
distribute a medical device including in vitro diagnostic medical device in the country.
Accordingly, all the SLAs are requested to accept the applications in hard copy from such
applicants of medical devices and dispose off the application expeditiously on priority and
also to ensure uninterrupted access/supply of such medical devices.
V9
(Dr V. G. Somani)
Drugs Controller General (I)
To
All State/ UTs Drugs Controllers
Copy to:
1. All Stakeholders/Associations of Medical Devices & In vitro Diagnostics.
2. All Zonal/Sub-Zonal offices of CDSCO
3. All Port offices of CDSCO
Copy for information to:
PS to DGHS
PS to JS(R)