Minutes of the First meeting of the reconstituted National Medical Devices Promotion

Council (NMDPC) held on 14.9.2022 under the chair of Secretary, DoP at Dr BR

Ambedhkar International Centre, Janpath, New Delhi.

The first meeting of the reconstituted National Medical Devices Promotion Council
(NMDPC) under the Chairpersonship of Secretary, Department of Pharmaceuticals was held
on 14.09.2022 at Dr Ambedkar International Centre, New Delhi. Besides representatives from
Government Organizations/ Departments, representatives of various Medical Device
Associations have attended the meeting and the list of participants is at Annexure.
02. JS, DoP welcomed all the participants. Secretary, DoP, in the opening remarks,
highlighted about the multi-disciplinary nature of the sunrise sector which necessitates the
Council. Secretary briefed that initially, the NMDPC was set up under the aegis of DPIIT and
recently, NMDPC has been reconstituted under the aegis of DoP in view of its mandate for
promotion of medical devices industry . She proposed that instead of taking general issues for
deliberations, council should strive to identify the core and important issues and attempt to
resolve them with the support of concerned stakeholders. A detailed presentation on various
initiatives of the Department of Pharmaceuticals for the Medical Devices sector was presented
by JS Policy (copy enclosed) and then, the agenda items were taken up for discussion.
03. The following agenda items were discussed in the meeting :-
a. Status update by DoHFW on the preparedness of licensing for Class-A and Class-B
Medical Devices
DCGI made a detailed presentation on the preparedness of the Regulator/SLAs for licensing of
Class-A and Class-B Medical Devices w.e.f 01.10.2022 (copy attached). It was informed that

 2492 applicants (manufacturers and importers) have applied for license for Class-A and
Class-B devices as on 13.09.2022 on CDSCO's SUGAM portal. 523 applications have
been processed and licenses have been granted which will be effective from 01.10.2022
and 615 applications are under process. Most of the applications are from Maharashtra,
Haryana, Tamil Nadu etc.
 At present there are 12 Notified Bodies which are registered with CDSCO. Also, 05
Central Medical Device Testing Laboratories (CMDTL) are notified for testing of legal
samples and 26 Medical Devices Testing laboratories (MDTL) are registered to carry
out testing or evaluation on behalf of a manufacturer. CDSCO has also published an
updated list of laboratories for conducting performance evaluation of IVD
Reagents/Kits and a list of laboratories for conducting performance evaluation for IVD
analyzers, instruments and software on its website.
 Various guidance documents are also available on CDSCO's website. Regarding human
resource, 236 posts of Medical Device Officers (MDO) have been notified by CDSCO.
States have also notified Medical Device Officers as per MDR, 2017. At present, 23 DI
(MD), 03 ADC (MD) are working in Medical Device division of CDSCO. Further, 219
new posts have been created at various levels.

During deliberations, related issues raised by the participants are as below;

i. Representative of ASSOCHAM highlighted the issue of Customs clearance not being

granted for spares/accessories when imported stand-alone and requested them to be
incorporated in the license itself. In response to this, DCGI informed that accessories
will normally be covered in the approval with the parent medical device.
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 ii. Associations expressed apprehension about discontinuity in business post 01.10.2022
if the license is not granted by SLAs within the time, even if the applicants have
complied with all the documentation on the portal. On this, DCGI assured that CDSCO
is cognizant of this and assured that business continuity will remain for applicants who
have applied for the license.
iii. Representative of AiMED highlighted the need to have recruitment rules for MDOs
framed, taking into consideration, the technical expertise required for the tasks from
these MDs and accordingly, the educational qualifications to be arrived and suggested
that mechanical engineering background instead of pharmacist background should be
preferred for MDOs.

After detailed deliberations, Secretary, DoP suggested to JS, DoHFW to ensure to take into
account the concerns regarding qualifications and proper cadre management for medical
device officers in the medical device vertical in CDSCO .
Further, as a measure of capacity building by CDSCO, Secretary requested industry
associations to collaborate with CDSCO and SLAs to hold seminars to educate the industry on
the licensing process as well as the filing of documentation for the same. Associations can help
in giving a list of technical speakers to CDSCO who can design the programs along with SLAs
for quick dissemination of information related to the licensing regime.

(Action: DoHFW, Medical Device associations)

b. Exemption of licensed Medical Devices from the labelling requirements of Legal
Metrology (LM) (Packaged Commodities) Rules, 2011:
JS DoP briefed on the progress of the proposal of DoP to remove the duplicity of regulatory
requirements for the labelling of licensed Medical Devices of Legal Metrology (Packaged
Commodities) Rules, 2011 as labelling requirements are followed by licensed medical devices
under Medical Device Rules, 2017.
All associations except AiMED requested for exemption of licensed medical devices from
labelling requirements under LM (Packaged Commodities) Rules, 2011 and harmonising the
additional requirements, if any, duly covering the same under the MDR, 2017. AiMED
represented that both may continue to better protect the consumers.
DoCA representative mentioned that India, along with other countries, is a member of the
Metric Convention and the signatory of the International Organization of Legal Metrology
(OIML) and the member countries have to follow the unanimously accepted provisions. He
further clarified that the LM (Packaged Commodities) Rules, 2011 are not required for B-2-B
transactions but are required to be complied only for B-2-C transactions.
JS (DoH&FW) emphasized that Drugs are exempted from LM (Packaged Commodities) Rules,
2011 and Medical Devices are defined as Drugs under the Drugs and Cosmetics Act. Further,
he clarified that earlier, very few medical devices were under Regulations and now all medical
devices are covered under MDR-2017 and there is no need for double regulations. On the
additional requirement of consumer helpline number on the label, required under LM
(Packaged Commodities) Rules, 2011, he clarified that DoHFW’s Materiovigilance
Programme handles the reporting of adverse events associated with the use of medical devices
and take corrective action.

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Secretary DoP, advised to DoH&FW and DoCA to remove the duplicity of regulatory
requirements for the labelling of licensed Medical Devices of Legal Metrology (Packaged
Commodities) Rules, 2011 for the licensed medical devices (as labelling requirements are
followed by licensed medical devices under Medical Device Rules, 2017) and harmonise the
regulations duly ensuring that the additional requirements, if any, are covered under MDR,
2017 to avoid over-regulation.

(Action: DoH&FW and DoCA)

Regulatory framework of Medical Devices involves not only CDSCO but other allied
regulators of medical devices. Hence, the work related to single window system for licensing
of medical devices may be explored and carried forward by the CDSCO.
(Action: CDSCO / DoHFW)
c. Simplification of registration on GeM Portal- on self-certification basis (with uploading
of licenses or applications for licenses) in place of cumbersome video assessment process:
The issue is deferred as the senior representative from GeM could not attend the meeting.

d. NABL certification for in-house laboratories of manufacturing of Medical Devices –

Request for revoking the same for manufacturers having ISO 13485 certification:
JS DoP gave a background to the issue about the mandate given by AERB to manufacturers of
X-Ray emitting medical devices to have their in-house labs accredited by NABL.
Representative of AERB explained that ISO-13485 is a medical device quality Management
System while ISO-17025 is a conformity assessment standard and checks competence of the
testing facility. Both the systems have a different mandate.
Representatives of the associations impressed on the issue that manufacturers who are getting
clearance of the manufacturing facility from AERB will have the extra cost burden to have
their in-house labs accredited to NABL and the process will also not add any value on safety
of product, as entire premises are already cleared by AERB.
To assess the additional cost burden, Secretary, DoP enquired with AERB about the frequency
of accreditation required and AEB informed that NABL certification is required only once for
each model of medical device. To the question, whether the AERB's mandate of NABL
accreditation of in-house labs is applicable only for Medical Devices related X-ray machines
or also to radiation machines from other sectors, AERB informed that this mandate is
applicable only for medical devices.
Council decided that AERB shall submit a note on the frequency of testing of medical devices
as mentioned above and the reason why only medical devices are covered under NABL
mandate

(Action: AERB / NABL)

e. Devices manufactured in EoU / SEZ to be covered under RoDTEP scheme:
Representative from DGFT informed that the Committee on RoDTEP has sought the data on
embedded non-reimbursed taxes for units operating in SEZ/EOUs and DGFT has already
issued a notification for the same. Medical Device Industry Associations were requested to
provide details/data of medical devices manufactured in EoU / SEZ.

(Action: Medical device Associations)

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5. After detailed deliberations of the agenda items, the Council decided the following to better
facilitate the medical device sector:

i. Issue related to CRO Order of MeitY will be taken up in the next meeting and the
representative from MeitY will be invited. All related papers have to be sent in advance
to MeitY.
ii. Associations may sensitize their members to collaborate with the State Govts. that
setting up Medical device parks in case they are looking for manufacturing ecosystem
for medical devices.
iii. The PLI guidelines for medical devices have been revised. Accordingly, Associations
are requested to come forward and disseminate the information among manufacturers.
iv. The Department is also expecting an order by DoC for creation of a separate Export
Promotion Council for Medical Devices.
v. The NMDPC may also explore a system of membership based participation of
individual industry members in the NMDPC going forward.

The meeting ended with vote of thanks to the chair.

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 Annexure
1. Ms. S. Aparna, Secretary, Department of Pharmaceuticals
2. Sh. Kamlesh Kumar Pant, Chairman, National Pharmaceutical Pricing Authority
3. Dr. N. Yuvaraj, Joint Secretary, Department of Pharmaceuticals
4. Sh. Rajneesh Tingal, Joint Secretary, Department of Pharmaceuticals
5. Dr. Mandeep Kumar Bhandari, Joint Secretary, Department of Health & Family
Welfare
6. Dr. V. G. Somani, Drugs Controller General of India, Central Drugs Standard Control
Organization
7. Ms. Shruti Singh, Joint Secretary, Department for Promotion of Industry and Internal
Trade
8. Dr. Sumit Garg, Deputy Secretary, Department of Pharmaceuticals
9. Sh. Rajib Kumar Sen, Senior Adviser, NITI Aayog
10. Ms. Padma Ganesh, Director, Department of Commerce
11. Dr. Praveen Kumar, Deputy DGFT, Directorate General of Foreign Trade (DGFT)
12. Ms Pallavi Saha, Joint Director, Engineering Export Promotion Council
13. Dr. Rajeev Singh Raghuvanshi, Secretary-cum-Scientific Director, Indian
Pharmacopoeia Commission
14. Dr. Pankaj Tandon, Head, TSS, Radiological Safety Division & Central Public
Information Officer, Atomic Energy Regulatory Board
15. Dr. Pankaj Johri, Director, National Accreditation Board for Testing and Calibration
Laboratories
16. Sh. Karan Rawat, Manager TP Creation Analyst, Government e-Marketplace
17. Sh. Ashutosh Aggarwal, In-charge Director, Legal Metrology, Department of
Consumer Affairs,
18. Sh. Arvind Kumar, Under Secretary, Department of Pharmaceuticals
19. Ms. Khushboo Paliwal, Technical consultant, DoP
20. Sh. Prashant Gupta, Technical consultant, DoP
21. Ms. Nishi Sharma, YP, DoP
22. Representative of FICCI
23. Representative of ADMI
24. Representative of AIMED
25. Representative of KIHT
26. Representative of APACMED
27. Representative of APMEI

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28. Representative of ASSOCHAM
29. Representative of CII
30. Representative of MTAI
31. Representative of USIBC
32. Representative of USISPF
33. Representative of AdvaMed
34. Representative of AMCHAM
35. Representative of PHDCCI

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