New portal for medical
devices registration in India (NSWS)
On January 01, 2024, India’s medical device regulator,
Central Drugs Standard Control Organization (CDSCO) issued
a notice that applications for certain medical device
related regulatory approvals will not be accepted on the
current medical devices CDSCO portal (CDSCO MD-Online
portal) after January 15, 2024. Instead, they will be
accepted through the National Single Window System (NSWS)
portal only. This transition is being implemented in
stages. In the first phase, medical device related
regulatory applications which are described below in this
article will be accepted through NSWS portal. In future
all medical device related regulatory applications will be
accepted and filed through the NSWS portal only.
What is NSWS portal?
The NSWS portal is a digital platform established by the
Indian Government with the aim to act as a single window
for all the approvals. The portal enables the investors
(manufacturers, importers, traders etc.) to obtain
registrations and approvals according to their business
requirements.
Which medical devices approvals could have been
obtained through NSWS portal prior to January 01, 2024?
Importers and manufacturers of medical devices were
previously able to use NSWS portal to make application for
legal metrology registration, wireless planning and
coordination wing’s (WPC) equipment type approval (ETA),
import export code (IEC), etc.
Going forward, which medical devices related regulatory
applications will be accepted through NSWS portal only?
From January 15, 2024, the list of medical device
applications which will be accepted through NSWS portal
are as follows:
• Application for license to import medical devices for
the purposes of clinical investigations or test or
evaluation or demonstration or training (Form MD-16).
• Application for license to manufacture medical device
for purpose of clinical investigations, test, evaluation,
examination, demonstration, or training (Form MD-12).
• Application for grant of certificate of registration of
a Notified Body (Form MD-01).
Is there any guidance for the filing of applications
for approvals on NSWS?
There is a user manual for the submission of the
applications through the NSWS portal which has been made
available by the Indian Government.
What happens to the applications that have been filed
before January 01, 2024?
The medical device regulatory applications which were
filed before January 01, 2024, through CDSCO MD-Online
portal will be processed on the same portal. The medical
device regulatory applications that are identified above
should not have been filed after January 01, 2024, on
CDSCO MD-Online portal. Importers and manufacturers of
medical devices will not be able to use CDSCO MD-Online
portal for filing regulatory application identified above
after January 15, 2024.
Which medical device regulatory applications will be
accepted through CDSCO MD- Online portal?
All applications excepting those described above,
including applications for import and manufacture of
medical devices will be accepted through CDSCO MD-Online
portal until further notice.
Conclusion
The transition of certain medical device regulatory
applications from CDSCO MD-Online portal to NSWS portal is
a welcome development for the importers and manufacturers
of medical devices because they will now be able to
determine licences/approvals applicable to their business,
apply for those approvals and track the status of their
applications under one roof i.e. NSWS portal.
(Ref: https://www.lexology.com/library/detail.aspx?g=af79a9a4-ef50-4763-9951-6de3cd0f60a3
Dated January 15 2024)
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