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Health ministry to remove requirement of audit for Class-A medical devices manufacturing site by notified bodies

Shardul Nautiyal, Mumbai
Saturday, November 21, 2020, 08:00 Hrs  [IST]

The Union health ministry may soon remove the requirement of audit for Class-A medical devices manufacturing sites by registered notified bodies based on the recommendation of the Drugs Technical Advisory Board (DTAB).

The medical devices division of Central Drugs Standard Control Organisation (CDSCO) has notified 6 bodies to carry out auditing of manufacturing sites as per the provisions of new Medical Device Rules (MDR-2017). The notified bodies registered with CDSCO are Intertek India Pvt. Ltd, TUV Rheinland India Pvt. Ltd, TUV Sud South Asia Pvt. Ltd, DNV GL, BSI Group India Pvt. Ltd and BSCIC Certifications Pvt Ltd.

According to DTAB, it was proposed to remove the requirement of audit of manufacturing site by the registered notified body since Class-A medical devices are least risk prone.

Industry has hailed the recommendation and said that this will expedite grant of licenses as it was time consuming as the notified bodies take a lot of time giving approvals.

As per rule 20 of the Medical Device Rules (MDR)-2017, the applicant needs to submit the application in Form MD-3 for license or in Form MD-4 for loan license for the grant of license in Form MD-5 or loan license in Form MD-6, as the case may be, to manufacture Class A medical devices.

MDR- 2017 which falls under the ambit of D&C Act is meant to regulate manufacture, import, sale and distribution of the medical devices.

The state licensing authority (SLA) after scrutiny of documents and on being satisfied that the requirements of these rules have been complied with, grants a license in Form MD-5 or loan license in Form MD-6, as the case may be, to manufacture Class A medical devices.

Further, the audit of the manufacturing site by a registered notified body in the manner specified in the third schedule of MDR-2017 is required to be carried out within one hundred and twenty days from the date on which the license was granted by the SLA.

However, the manufacturer should submit self-certification of the compliance of all the submitted documents to the SLA for grant of license to manufacture Class A medical devices.

MDR 2017 were notified last year and came 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.

New MDR 2017 covers medical devices, in-vitro diagnostics (IVDs), disinfectants, surgical sutures, ligature, condoms, bandages etc. It sets new standards for manufacturing and use of medical devices.

SLA has to send applications to the notified bodies for inspections and auditing of Class A and Class B category medical devices towards compliance to the new rules. Class C and Class D categories are audited by the CDSCO independently as per the new rules.


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