Medical Devices Industry To Align With Global Norms
Mr. Anil Jauhri
Ex CEO – NABCB,
The National Accreditation Board for Certification Bodies
|(As Published on “Trade
Council of India” Website, June 25, 2023)
The Indian medical device market is relatively smaller
than other overseas markets but holds significant growth
potential. But to fully capitalize on this potential, it
is crucial to assess the country’s compliance with global
standards and explore avenues for improvement.
The Indian medical device market is
relatively smaller than other overseas markets but holds
significant growth potential. Currently estimated at US$
11 billion, it is expected to reach US$ 50 billion by
2030, under the New Medical Devices Policy.
India’s medical device industry has
experienced significant growth and the country is poised
to become a key player in the global market. However, to
fully capitalize on this potential, it is crucial to
assess the country’s compliance in line with global
standards and explore avenues for improvement. We need to
ensure the adoption of international standards as national
standards by BIS wherever available. This facilitates
access to foreign markets, toys being the recent example.
Similarly, in the medical device
industry, referencing international standards should be
prioritized over national standards such as the Bureau of
Indian Standards (BIS), until BIS adopts all international
Compliance to regulations is not
solely about standards but also about effectively
demonstrating adherence in internationally acceptable ways.
The example of gold purity illustrates that the product
standard remains the same globally, but with the demonstration
of compliance not being internationally acceptable, India’s
hallmarking scheme is unacceptable overseas.
To ensure the acceptance of
regulated Indian medical devices worldwide, it is imperative
to harmonize not only the standards but also the manner in
which compliance is demonstrated. This calls for a
comprehensive approach that encompasses both the standards
themselves and the processes for assessing compliance.
Fortunately, Medical Devices Rules, 2017 do rely on
accreditation for notified bodies as well as laboratories
which needs to be further leveraged.
Mutual Recognition Arrangements
Establishing mutual recognition
arrangements (MRAs) with other countries is a viable option
for facilitating exports, even when national standards are not
at par with international standards. However, before pursuing
MRAs, India needs to establish a robust system for certifying
medical devices to global standards, if domestic standards are
Examples of successful
initiatives like APEDA’s organic system and the Export
Inspection Council’s seafood certification showcase that the
effectiveness of such systems in gaining international
acceptance. The promotion of a certification program like
ICMED 13485 Plus, which certifies compliance with global
standards, can further enhance India’s export capabilities by
being presented as a viable system to overseas regulators.
The availability of accredited
laboratories is crucial to ensure proper testing and
compliance verification of medical devices. While the
requirement for accreditation exists, the shortage of labs
poses a significant challenge.
In general, the private sector
responds when there is demand for testing, for which the N95
masks are a good example. But there would be medical devices,
especially complex ones, where there would be limited
manufacturing in India and demand for testing would be low.
This would not attract the private sector. To overcome this
hurdle, the government should identify areas where private
sector investment is unlikely and establish labs in
collaboration with institutions like IITs and NIPERs without
regard for returns like a commercial lab but as a national
service. These labs should adhere to international standards,
regardless of whether they are government-owned or
By ensuring the presence of
reliable labs, both for domestic manufacturing and import
surveillance, India can bolster its position as a globally
competitive player. To sum up, to create a progressive medical
device industry in India, a roadmap should focus on the
following important areas:
Standards, which prioritize compliance with global standards
over national standards, positioning Indian medical devices as
aligned with international expectations.
certification, which helps to recognize and reward
manufacturers who voluntarily obtain certifications such as
ISO 13485 or BIS certification or ICMED certification as per
market need. These certifications, when partially or fully
aligned with regulatory requirements, can reduce risk for
regulators and help allocate resources more efficiently. This
would be in line with global trend of taking cognizance of
voluntary efforts of industry. Establish regulatory
provisions, which will Integrate provisions into CDSCO
regulations that acknowledge voluntary certifications and
consider them as evidence of compliance. This approach reduces
the burden on regulators, while encouraging industry
participation in exceeding regulatory expectations.
Infrastructure, which will help to identify areas with a
shortage of labs and limited private sector investment
potential. Support institutions like IITs and NIPERs to
establish labs in these regions. Funding should be provided,
and commercial returns should not be the primary focus to
ensure the availability of reliable testing facilities.
Whiile India’s medical device
industry has immense growth potential, realizing this
potential requires prioritizing international standards,
strengthening laboratory infrastructure, implementing clear
action plans, and incentivizing voluntary certifications. By
aligning with global norms and adopting best practices, India
can position itself as a reliable and innovative hub for
medical devices, fueling economic growth and improving
healthcare outcomes both domestically and internationally.