Last Updated on February 21, 2024 by The Health Master
The Drugs Controller General of India (DCGI) has further extended deadline by 4 months or till normalization of C-19 scenario to submit notarized or apostilled regulatory documents for import and registration of cosmetics such as power of attorney, QMS certificate, free sale certificate (FSC) and manufacturing license with legal signatures due to C-19 pandemic.
The DCGI’s action in this regard comes in the background of the fact that his office had received representation from the industry about difficulties in submission of notarized or apostilled regulatory documents for cosmetics due to C-19 pandemic.
According to DCGI Dr V G Somani, “The matter has been examined carefully in view of the situation due to C-19 and in continuation of the notice dated April 20, 2020 and August 19, 2020.
It has been decided that the applicant may submit applications for import registration as per the provisions of Drugs and Cosmetics (D&C) Act, 1940 and Rules made thereunder along with such documents which are self-attested and an undertaking.
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The undertaking stipulates that the applicant will submit the notarized or apostilled documents with legal signatures after obtaining the same from the concerned authority after normalization of the situation in the light of C-19 or within four months whichever is earlier.”
Earlier the DCGI had also issued notice to submit applications for import license as per the provisions of Medical Device Rules (MDR) 2017 along with such documents which are self-attested and an undertaking that they will submit the notarized/apostilled documents after obtaining the same from the concerned authority after normalization of the situation in light of C-19 or within four months whichever is earlier.
The DCGI has further extended the deadline up till 4 months or till normalization of C-19 scenario to submit notarized documents through online Sugam portal for import of medical devices and in-vitro diagnostics (IVDs) from the earlier deadline of April 24, 2020. In its April 24, 2020 notice, it had directed all the concerned to do the needful.
DCGI office had received representation about difficulties in submission of notarized or apostilled regulatory documents such as power of attorney, QMS certificate, free sale certificate etc for applications for import of medical devices and in-vitro diagnostic kits under MDR- 2017 due to C-19 pandemic.
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