6 month extension for licenses for 4 notified medical devices


Last Updated on January 1, 2021 by The Health Master

The medical device industry has welcomed the Centre’s move to notify additional 6 months timeline for getting licenses for 4 notified medical devices namely nebulizers, blood pressure monitors, digital thermometers, and glucometers.

To download the DCGI order dated 28-12-2020, click here

Accordingly, as per the Central Drugs Standard Control Organisation (CDSCO) order, the importers/manufacturers are required to take import/manufacturing license from Central Licencing Authority (CLA) or State Licencing Authority (SLA), as the case may be, for import/manufacture of above devices, w.e.f. January 2021.

A representation was received requesting to extend the implementation of the notification for another 3 to 6 months because a lot of procedural work is to be done such as the resolution of queries, the audit of facilities by the regulators and notified bodies, as the case may be, testing of products at the requisite testing labs etc.

The CDSCO had earlier brought devices like digital thermometers and blood pressure monitoring devices under regulation as per new Medical Device Rules (MDR) 2017 from January 1, 2020, to address misdiagnosis at the point of care.  

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According to studies done in the past few years, seventy percent of digital blood pressure monitors used at homes are unacceptably inaccurate and could cause serious implications for people who rely on them.

The India Heart Study (IHS) released in August 2019 has also revealed 42 per cent of Indians are at risk due to misdiagnosis of hypertension.

VG Somani DCGI
Dr. VG Somani, DCGI

“Devices like digital thermometer and blood pressure monitoring devices the primary intended purpose of which is for temperature monitoring or blood pressure monitoring (unit parameter) will be considered under the purview of regulation with effect from January 1, 2020. These were notified on December 3, 2018,” said Drugs Controller General of India (DCGI) Dr V G Somani in an earlier notice.

“We are thankful that additional 6 months timeline has been provided for seeking the license. It will be interesting to know how many applications have been received by CDSCO for manufacturing and import licenses for these four medical devices notified as drugs and how many are being granted the license,” said Rajiv Nath, forum coordinator, Association of Indian Medical Device Industry (AiMeD).

In this regard, it may be pertinent to mention that Rule 97 of Medical Device Rules (MDR) 2017 provides details about applicability of the said rules in respect of various actions/operations undertaken under Drugs & Cosmetics (D&C) Rules for the substances and devices referred to in rule 2 of the MDR, 2017 prior to commencement of MDR 2017, as per the notice.

In view of the above, it has been decided that in case an existing importer/manufacturer who is already importing /manufacturing any of these devices, has submitted application CLA or SLA, as the case may be, for grant of import/manufacturing license in respect of the said device(s) under the provisions of MDR, 2017, the said application shall be deemed valid and the importer/manufacturer can continue to import/manufacture the said device(s) up to 6 months from the issue of this order or till the time, the CLA or the SLA, as the case may take a decision on the said application, whichever is earlier.

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