The Personal Connected Health Alliance (PCHAlliance) submitted a memorandum to the Department-Related Parliamentary Standing Committee on Health & Family Welfare regarding regulating medical devices in India. The PCHAlliance recommends establishing regulatory standards for both clinical and information and communication technology aspects of medical devices. It also recommends developing test specifications, certification bodies and labs to ensure devices meet standards. Further, the PCHAlliance proposes policy changes like exempting startups from experience criteria in government tenders and reserving some government procurement for local manufacturers to boost the medical devices sector in India. The PCHAlliance requests to present these views in person to the committee.

1. 10 102, Siddhivinayak, Plot 3, Sec 14, Khanda , New Panvel , Mumbai 410206. MH. India. | www.pchalliance.org
Date: Jan 05, 2018
To,
Prof. (Dr.) Ram Gopal Yadav,
M.P. (Rajya Sabha)
Chairman
Department-Related Parliamentary Standing Committee on Health & Family Welfare
Rajya Sabha Secretariat, New Delhi 110001
Subject: Submission on Medical Devices: Regulation and Control
Respected Sir and Hon’ble Members of the Committee.
This note is in response to the advertisement inviting memoranda on the above-mentioned
subject. We are writing this on behalf of the Personal Connected Health Alliance (PCHAlliance) –
India.
About PCHAlliance: PCHAlliance aims to make health and wellness an effortless part of daily
life. The PCHAlliance, a non-profit organization formed by HIMSS, believes that health is
personal and extends beyond healthcare. The PCHAlliance mobilizes a coalition of stakeholders
to realize the full potential of personal connected health. PCHAlliance members are a vibrant
ecosystem of technology and life sciences industry icons, and innovative early stage companies,
along with government, academic institutions, and associations from around the world.
Medical devices will increasingly play a crucial role in the healthcare system, and the interface
between software and medical devices will become as regular and important as the interaction
between the doctors and the patients. Hence, there is a need to look at the regulation for
medical devices from an ecosystem perspective, which ensures that the medical devices are of
a world class standard and act as an enabler for the growth of the Med-Tech Industry.
We wish to submit the following to the committee for their perusal and kind consideration:
A. Regulatory standards for devices - both for clinical as well as for ICT aspects on how the
data is transmitted and how the data is consumed / interpreted, paying specific attention to
framing guidelines and regulations for privacy, security and interoperability of data
transmitted
A comprehensive report on interoperability of medical devices in India is available online and
can be used as a reference. Link to download the report
https://www.slideshare.net/rajendrapgupta/edit_my_uploads?page=2
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2. 10 102, Siddhivinayak, Plot 3, Sec 14, Khanda , New Panvel , Mumbai 410206. MH. India. | www.pchalliance.org
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B. Test specifications for devices - specifications to test the devices that they meet the
standards. Of course, there is a need for test labs for this purpose as well.
C. Certification body and labs - All devices (or appropriate samples of a batch) have to be
tested by approved laboratories, and need to carry stamp of a certification body (which has
originally set the regulatory standards).
D.DIPP registration benefits: Startup registration from DIPP should give exemption from
previous experience (3 years), turnover criteria and EMD/security deposit in government
procurement, provided quality and price is matched. This will boost participation of startups in
the government tender process, making the system more competitive and boosting the early
stage Medtech companies
E. Buy from India policy: Some amount of government procurement for low and medium risk
devices should be reserved for local manufacturers. This will boost the sector immensely.
Streamlining the buying process with alignment of individual state governments is also crucial
If the medical devices are not interoperable (they don’t connect seamlessly to each other and
to the software), there is a risk of the patient’s vital signs data being lost or distorted. Since this
is a serious issue, we would like to come and present before the committee our views and
reports developed on this topic.
We need to have a strong and enforceable regulatory framework for medical devices and
software. Globally, there has been a move to recognize medical software as a drug (US FDA),
and we are not far, when such medical software’s will be classified as ‘Med-Tech Devices’. India
should take a lead in addressing this issue since India would become the startup capital for
med-tech in the years to come.
The following members would form a part of the PCHAlliance delegation which would like to
come and meet with the Hon’ble Members of the committee to discuss various aspects;
1. Medical devices start-up CEOs (2 CEOs)
2. Global medical device company’s standards head (2)
3. Software driven med-tech Indian start-up (2)
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3. 10 102, Siddhivinayak, Plot 3, Sec 14, Khanda , New Panvel , Mumbai 410206. MH. India. | www.pchalliance.org
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4. National Coordinator for PCHA – India
5. Chairman, PCHA India
6. Representative from NHSRC – Ministry of Health & Family Welfare’s organization
working in standards for medical devices (1 representative)
7. ‘Bureau of Indian standards’ representative (1 Representative)
We would like to come and present our views on the need for standards and interoperability
for medical devices and software and also, various aspects that could make India the ‘Med-
Tech’ destination for the world.
Should the committee need any further details or clarification, we would be happy to address
the same. We look forward to presenting our views to the Hon’ble members of the committee
‘in person’, and await your response.
With best regards
Rajendra Pratap Gupta
Chairman
For and on behalf of the Personal Connected Health Alliance
Cell: +91 9 22 33 44 303
Ms. Mevish P. Vaishnav, National Coordinator: 8123618929
E: office.rajendra@gmail.com / Mevish@dmai.org.in