Ø Proposed amendments seek to
simplify regulatory requirements, standardize testing fees and facilitate
faster market access for eligible medical devices
Ø Loan Licensing requirements
removed for outsourced sterilization activities
·
Regulatory
reforms:
The Government has amended the Medical
Devices Rules, 2017 to simplify regulatory procedures, improve
transparency and accelerate access to advanced medical technologies.
·
Outsourced
sterilization:
Rule 44
has been amended to simplify licensing requirements for manufacturers
outsourcing medical-device sterilization.
·
No
separate loan licence: Manufacturers using a
sterilization facility that already holds a valid licence
under the Medical Devices Rules, 2017 will no longer need a separate loan licence
for the outsourced sterilization activity.
·
Reduced
compliance burden:
The change eliminates duplication, lowers administrative and compliance costs
and reduces approval timelines, particularly for manufacturers without in-house
sterilization facilities.
·
Six-month
transition:
A six-month transition
period has been provided for the new labelling requirement,
allowing manufacturers time to modify packaging, labels and related processes.
·
Traceability
retained:
The reform simplifies licensing while maintaining an essential traceability mechanism
for outsourced sterilization.
·
EU
added to recognized jurisdictions: Rule
63 has been amended to include the European Union (EU)
among stringent regulatory jurisdictions recognized for waiver of clinical
investigation requirements.
·
Existing
recognized jurisdictions: The list already includes the US, UK, Australia, Canada and Japan.
·
Clinical
investigation waiver:
Eligible medical devices without predicate devices that have already been
approved in the EU can now benefit from the clinical investigation waiver, potentially
speeding up their introduction in India.
·
Benefits
for industry:
The changes are expected to reduce regulatory burdens, costs and timelines for medical-device manufacturers and
importers.
·
Faster
technology access:
The reforms aim to facilitate quicker availability of advanced and innovative medical devices
to Indian patients.
·
Regulatory
convergence:
Recognition of the EU framework is expected to strengthen international regulatory convergence
in the medical-device sector.
·
Overall
objective:
The reforms seek to balance Ease
of Doing Business with quality, safety, performance and regulatory oversight,
while improving the competitiveness of India's medical-device industry.
<G.S.R. 743(E dated
14.08.2026>
[ABS News Service/24.08.2026]
The
Government has introduced key regulatory reforms in the medical device sector
with a view to promoting Ease of Doing Business (EoDB),
simplifying regulatory processes, enhancing transparency and facilitating
timely access to advanced medical technologies in the country.
Towards
this objective, the Medical Devices Rules, 2017 have recently been amended to
simplify the regulatory framework governing outsourced sterilization of medical
devices and to expand the list of recognized stringent regulatory jurisdictions
for waiver of clinical investigation requirements.
The
amendment to Rule 44 of the Medical Devices Rules, 2017 has been finalized
after extensive stakeholder consultations with the objective of simplifying
regulatory compliance for medical device manufacturers availing outsourced
sterilization facilities.
Under
the amended provisions, manufacturers outsourcing product sterilization to
another facility holding a valid licence under the
Medical Devices Rules, 2017 will no longer be required to obtain a separate
loan licence for the outsourced sterilization
activity.
The
amendment eliminates the requirement for a separate loan licensing process in
such cases, thereby reducing duplication, administrative burden, compliance
costs and associated timelines, particularly for manufacturers that do not have
in-house sterilization facilities.
The
amended provision also provides a six-month transition period for
implementation of the new labelling requirement. This will allow manufacturers
adequate time to make necessary changes to their labelling, packaging and
related processes before the provision comes into effect.
The
reform seeks to strike a balance between regulatory oversight and ease of doing
business by simplifying the licensing framework while retaining an essential
traceability mechanism for outsourced sterilization.
The
measure is expected to provide greater operational flexibility to
manufacturers, facilitate faster and more efficient manufacturing processes,
and support the growth and competitiveness of India’s medical device industry.
Additionally,
Rule 63 of the Medical Devices Rules, 2017 has been amended to include the
European Union (EU) among the recognized stringent regulatory jurisdictions for
waiver of clinical investigation requirements for medical devices without
predicate devices.
The
provision currently recognizes the United States of America, United Kingdom,
Australia, Canada and Japan. With the inclusion of the European Union, eligible
medical devices that have already been approved in the EU will be able to
benefit from the waiver provisions, facilitating faster patient access to
advanced medical technologies in India.
The
amendment is also expected to reduce the regulatory burden and associated
timelines for importers and manufacturers while strengthening international
regulatory convergence in the medical device sector.
These
reforms are expected to simplify regulatory processes, reduce costs, enhance
transparency and predictability, and facilitate the timely availability of
advanced and innovative medical devices in India.
The
measures represent an important step towards strengthening the medical device
regulatory ecosystem and promoting greater Ease of Doing Business, while
continuing to maintain robust standards of quality, safety and performance of
medical devices.