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Government of India
Central Drugs Standard Control Organisation
Directorate General of Health Services
Ministry of Health & Family Welfare
(Medical Devices and Diagnostics Division)
FDA Bhawan, Kotla Road, New Delhi-11 0002
File No: IVD/Misc/045/DCGI/18 Dated,
To:
All Zonal and Sub Zonal Offices of CDSCO
Subject: Inspection of manufacturing site of Class C and Class D medical devices
including In-Vitro Diagnostic Medical Devices under the provisions of MDR 2017 -
Regarding
Sir,
It has been decided that, application made to the Central Licensing Authority through the
online portal i.e cdscomdonline.gov.in for licence or loan licence to manufacture for sale or for
distribution, as the case may be, of Class C or Class 0 medical device including In-Vitro
Diagnostic Medical Devices in Form MD-7 or Form MD-8, respectively shall be scrutinized and
processed by the concern CDSCO Zonal or Sub Zonal Offices within a period of forty five days
from the date of online submission of application. In case, where the documents are found to be
complete and in order, the respective CDSCO office shall cause an inspection of the
manufacturing site as earlier as possible as per rules. In case of critical cases MOO or ADC(I)
from CDSCO (HQ) may be included in the inspection team.
Yours Faithfully,
~
(Dr. S. ~eddY)
Drugs Controller General (India)
I