Ø Comments to be submitted by stakeholders
on or before 15 July 2026
·
The
Department of Pharmaceuticals has invited comments from stakeholders on
proposed amendments to the Global
Tender Enquiry (GTE) Exemption List for Medical Devices.
·
The
Department had earlier issued a Public
Notice on 11 February 2026 seeking feedback on the existing GTE
Exemption List.
·
Following
the notice, the Department received several representations from stakeholders
regarding changes to the list.
Stakeholders
have requested:
·
Addition of new medical devices to the exemption
list.
·
Deletion of certain existing entries.
·
Modification of specifications or descriptions of
devices already included in the list.
·
The
GTE Exemption List identifies medical devices that may be procured through Global Tender Enquiry
despite restrictions favoring domestic procurement.
·
Such
exemptions are generally considered when:
o Domestic manufacturing capacity is
insufficient.
o Required technology is not adequately
available in India.
o Specialized healthcare needs require
access to imported products.
The
Department has invited comments from:
·
Domestic
medical device manufacturers.
·
Importers.
·
Industry
associations.
·
Government
procurement agencies.
·
Hospitals
and healthcare institutions.
·
Other
interested stakeholders.
·
Stakeholders
are requested to provide:
o Comments on the proposed additions,
deletions, or modifications.
o Supporting information and evidence to
justify their views.
·
Comments
must be submitted on or
before 15 July 2026.
Comments
may be sent via email to:
·
usmedicaldevices@pharma-dept.gov.in
·
Copy
to: so-medicaldevices@pharma-dept.gov.in
·
The
consultation forms part of the government's ongoing effort to balance:
o Promotion of domestic medical device
manufacturing under the Make
in India initiative.
o Ensuring access to advanced and critical
medical technologies where domestic supply may be inadequate.
·
The
outcome could influence future procurement opportunities for both domestic and
foreign medical device suppliers.
The Department of
Pharmaceuticals is reviewing the Medical Devices GTE Exemption List and has
invited stakeholder feedback on proposed additions, deletions, and
modifications. The consultation aims to ensure that public procurement policies
support domestic manufacturing while maintaining access to essential and
advanced medical technologies.
The
Department of Pharmaceuticals has invited comments from stakeholders on the proposals
received for amendments to the Global Tender Enquiry (GTE) Exemption List of Medical
Devices. Following a Public Notice issued on 11 February 2026 seeking feedback on
the existing GTE Exemption List, the Department received representations from various
stakeholders requesting addition, deletion and/or modification of entries under
the list.
All
concerned stakeholders, including domestic manufacturers, importers, industry associations,
procurement agencies and healthcare institutions, have been requested to submit
their comments along with supporting information on or before 15 July 2026 through
email at usmedicaldevices@pharma-dept.gov.in with a copy to so-medicaldevices@pharma-dept.gov.in.