Last Updated on July 3, 2021 by The Health Master
The Central Drugs Standards Control Organisation (CDSCO) has appointed 172 drug inspectors as medical device officers (MDO) under the new Medical Device (MD) Rules 2017 to regulate manufacture, import, sale and distribution of medical devices.
Medical Device Rules 2017 was notified vide G.S.R. 78 (E) dated January 31, 2017 under Drugs and Cosmetic (D&C) Act, 1940 and the said rules are effective from January 1, 2018.
As per the new Rules, state licensing authority (SLA) has to send applications to the notified bodies appointed by the Central government for inspections and auditing of Class A and Class B category medical devices for compliance. Class C and Class D categories are audited by the CDSCO.
As per the latest Union health ministry notification, “In pursuance of the powers conferred under sub-Rule (2) of Rule 18 of the Medical Devices (MD) Rules, 2017,the following inspectors of the Central Drugs Standards Control Organisation, appointed by the Central government under Section 21 of the D&C Act, 1940 (23 of 1940), are hereby designated, for the whole of India, as medical device officer’s for the purpose of the said Rules with immediate effect and until further orders.”
The Union health ministry has also notified eight bodies which are registered with CDSCO under provisions Medical Devices Rules, 2017 to carry out audit of manufacturing sites under the provisions of said Rules.
Following Notified Bodies have been registered with CDSCO like Intertek India Pvt. Ltd, TUV Rheinland India Pvt. Ltd, TUV Sud South Asia Pvt. Ltd, Dnv GI Business Assurance India Private Limited, BSI Group India Pvt. Ltd, BSCIC Certifications Pvt Ltd, TUV Intercert SAAR India Private Limited, Zenith Quality Assessors Pvt. Ltd.
Government of Maharashtra through a notification has designated all the appointed drug inspectors under sub-Section (1) of Section 21 of the D&C Act, 1940 as the medical device officers for implementing MD Rules 2017.
Currently, there are 129 drug inspectors in Maharashtra and 13 in Mumbai.
New MD Rules 2017 were notified last year and have come into effect from January 1, 2018 onwards in the country. Following the notification, issues related to post grant compliance, data protection, product recalls and product liabilities among others will be implemented effectively towards device or product safety.
As of today, 37 medical device categories have been notified. Earlier, 26 medical devices were notified between 2005 and 2017 which has under its ambit 364 products. In December, 2018 three new devices like nebuliser, glucometer and surgical gowns were notified.
New MD Rules 2017 cover not only medical devices but also in vitro diagnostics, disinfectants, surgical sutures, ligature, condoms, bandages, etc. It sets new standards for manufacturing and use of medical devices.