Medical Devices Webinar

Shaping India’s Medical Devices Regulatory Framework: Global Best Practices and Priorities

India’s medical devices industry is poised for significant growth in the next five years, with the market size expected to reach $50 billion by 2025. It includes both large multinationals and small to medium enterprises (SMEs), and it is growing at an unprecedented scale: its current market size is estimated to be nearly $10 billion. 

TIC Council fully supports the crafting of a robust medical devices rules regulatory and policy framework which lays a strong foundation towards ensuring a robust quality and conformity ecosystem for medical devices in India. 

In the healthcare sector, patient and operator safety are of paramount importance, which makes it imperative for medical devices to be of high quality and safe for their intended use, therefore a rapidly evolving medical device industry needs hand holding from all stakeholders, in order to be able to realize the government’s vision of quality and affordable healthcare for all. 

Embarking on the mission of patient safety in India, TIC council is organizing a two-day webinar on Shaping India’s Medical Devices Regulatory Framework: Global Best Practices & Priorities. The webinar will witness the presence of senior policy makers from Ministries & regulatory bodies of India, E.U & U.S along with senior industry leaders from the medical devices and TIC industry, sharing their experience, global trends and best practices towards ensuing quality and safety of medical devices. This webinar is a must-attend for industry leaders, decision makers, quality, regulatory and public affairs personnel from the healthcare sector.

Details 

The webinar will be held in two days: Thursday 28 October 2021, 14:30-17:00 IST (11:00-13:30 CET), and Friday 29 October 2021, 14:30-17:00 IST (11:00-13:30 CET)

Registrations will be open to all TIC Council Members and relevant stakeholders, as well as a larger external audience. 

Speakers: 

Day 1:  

  • Suresh Sugavanam, Chairman, TIC Council India
  • Hanane Taidi, Director General, TIC Council
  • Niranjan Nadkarni, CEO, TÜV SÜD South Asia, South East Asia, Middle East & Africa Region
  • Karthik Venkataraman, Business Manager, UL India
  • Claire Dyson, Global Vice President, Dekra
  • Kimberly Trautman, Medical Device, IVD and Combination Product Regulatory & Quality Expert
  • Latika Vats, Director, Regulatory Affairs & Quality Assurance for India Medtronic and APAC Med Committee
  • Reinaldo Figueredo, ISO-CASCO Chair
  • Sudhir Zutshi, Chair, Public Affairs, Sub Committee, TIC Council India

Day 2: 

  • Dr. R P Singh, Secretary General, QCI
  • Dr. Shailendra Singh, TUV SUD Pvt Ltd.
  • Jitendra Sharma, Managing Director and CEO, AMTZ
  • Ravi Kant, DDC, CDSCO (TBC)
  • Rajesh Maheshwari, CEO, NABCB
  • Ravi Singh, Member, TIC Council, Med Device WG
  • Dr. Girdhar Gyani, Director General, AHPI
  • Harshit Thakkar, Sr. Project Manager, DEKRA
  • Sudhakar Mairpadi, Head Quality, Regulatory and Govt Affairs, Philips India Pvt Ltd
  • Rajiv Nath, Forum Coordinator, AiMED
  • Vibhav Garg, Director-Health Economics & Govt Affairs, Boston Scientific
  • R Asok Kumar, Chairman, Regulatory Sub Committee, Adva Med
  • Dr. Aparna Dhawan, Executive Director, TIC Council India

REGISTRATION

Further Details:

The microphone function will be disabled for participants during the webinar but all questions for the presenter can be submitted through Webex via the chat function during the Q&A session at the end.

For further questions, please do not hesitate to contact – secretariat@tic-council.org

We look forward to welcoming you and/or your colleagues. 

For more information – https://tic-council.idloom.events/shaping-india-s-medical-devices

Medical Labs Trainings

MELAP – ONLINE PROGRAMS

Date: 17-18 November 2021
Program : Molecular Diagnostics in COVID 19

Time for both days: 09:30am-01:30pm
Fee – Rs 4000/- all inclusive

Registration link for Molecular Diagnostic in COVID 19 :
https://bit.ly/2Zp2rV5

For detailed information, please contact :

Ms Tripti-9958697309
Dr Jain -9810492621

Telegram group:
https://t.me/joinchat/TU5KxI1INydP7Ghr

WhatsApp group: https://chat.whatsapp.com/JRsns9vptTNJqfynaSIUsO

Facebook page
https://www.facebook.com/profile.php?id=100071765581442

Linked In page
https://www.linkedin.com/in/dr-neeraj-jain-96386446

website: www.melap.in

Webinar for Med Tech Startups

Webinar with Medical Technology Start-ups on 26 Oct 2021 – Invitation 

Program Announcement from BIS for Med Tech Startups
Webinar with Medical Technology Start-ups on 26 Oct 2021 – Invitation 

Bureau of Indian Standards (BIS), the National Standards body of India, is formulating Indian Standards in various fields. In the field of medical devices and related aspects, BIS has formulated around 1450 standards under its Medical Equipment and Hospital Planning Division Council(MHDC).

With an objective to impart awareness regarding existing Indian Standards on medical devices among the Medtech Start-ups community as well as to explore the feasibility of formulating standards on the novel medical devices developed/being developed by them, the Medical Equipment and Hospital Planning Department (MHD) of BIS is organizing a Webinar with Medical Technology Start-ups on 26 October 2021 from 1400-1700 hrs.

The details of the link for joining the webinar are as follows:

Date26 Oct 2021 (Tuesday)
Time1400 h to 1700 h
Link to joinhttps://bisindia.webex.com/bisindia/j.php?MTID=mec53359b4f7429c481f7ef5c5ec97ebd
Meeting No.2513 899 2572
PasswordBIS@2021

You are cordially invited to participate in the webinar. There is no registration/participation fee. 

Please click on the link below to register :

Contact :
Medical Equipment & Hospital Planning Department
Bureau of Indian Standards
Manak Bhavan
9, Bahadur Shah Zafar Marg
New Delhi – 110 002
Ph : 011-23230910

Indian Clinical Trial & Education Network (INTENT)

EoI Announcement from ICMR

Expression of Interest (EOI) for Participation in “Indian Clinical Trial & Education Network (INTENT)”.

The Indian Council of Medical Research (ICMR) under the Department of Health Research
(DHR), Ministry of Health & Family Welfare,
Government of India, is the apex biomedical
research body in the country for formulation, co-ordination, and promotion of medical research.
The overall goal of ICMR-DHR is to generate evidence to inform policy, program and practices
pertaining to health care in India.

Clinical Studies, Trials and Projection Unit (CSTPU), Indian Council of Medical Research (ICMR),
Department of Health Research (DHR) proposes to launch the Indian Clinical Trial & Education
Network (INTENT), which will serve as a pan-India network of institutes with proven excellence
in clinical research. The network, thus established, will conduct large scale, multi-centric clinical
trials in a timely and well-regulated manner.

Why clinical trial network ?
INTENT envisages to provide evidence-based, cost effective, scientifically sound, and culturally appropriate solutions to diseases and health issues of national and/or regional importance. It will provide a single platform to conduct a range of randomized clinical trials (RCT), that will enable harmonization of trial methods, pooling of results and timely completion of the projects, along with an inclusive representation of the diverse Indian communities. Additionally, this network will be at the forefront for capacity building of a pool of health researchers across the country. The trainees will acquire requisite skills to plan and conduct RCTs and to analyse and disseminate the results that could inform policy and practice.

Structure of INTENT
INTENT will work on a hub and spoke model with a co-ordinating centre located at ICMR-DHR. Hubs will be distributed over the six regions of the country (North, South, East, West, Central and North-east) and will function as nodal point for RCTs in that region. These Advanced Centres for Clinical Trials (ACCT) will include Institutes/Medical Colleges/Hospitals of repute with rich experience and expertise related to RCTs. They will have functional linkages with Multidisciplinary Research Unit (MRU) and/or Model Rural Health Research Unit (MRHRU) under the aegis of ICMR-DHR in the region.

Each regional hub, thus identified, will act as the mentoring body for a region, with the responsibilities of supportive supervision and troubleshooting as required. They will have an inclusive expansion plan so that the newly identified potential partnering agency/institutes/organizations are inducted in the regional network. The identified MRU/MRHRU will act as a Regional Clinical Trial Unit (RCTU), responsible for daily functioning and monitoring of the trials. Each regional hub will select their study sites (spokes) as per the research question to be answered. Funding for human resource, as well as for the mentoring activities at each of these hubs will be provided by ICMR-DHR (Figure 1). The number of regional hubs will be scaled up in a phased manner. Disease-oriented domain specific networks within INTENT will be recognised according to the
domain expertise and subject specific clinical requirements.

Who can apply for Advanced Centre for Clinical Trial?
Govt. Medical Colleges/Institutes
Private Medical Colleges/Institutes
Hospitals with experience of conducting RCTs
ICMR Institutes .

Investigators motivated to lead the regional hubs can apply with institutional approval.

Criteria for selection
Investigator
a. Endorsed by the Head of the Institute/College
b. Experience of initiating/participating in multi-centric RCT
c. Good quality publications on RCTs
d. Subject specialization
e. Preferably a multi-disciplinary team of investigators to be involved, with at least 2 of the team members being mid-level faculty (associate or additional professor, or equivalent experience)

Institute
a. Community outreach programme
b. Access to potential trial participants, both in-patient and outpatients
c. History of collaboration with other institutes/medical colleges/community-based organizations
d. Catchment area catering to various geographical and population groups
e. Presence of requisite infrastructure and space

Trials to be conducted via INTENT
Research priorities of INTENT will reflect the national and/or health priorities of urgent and important nature. Among others, the areas which will be covered by INTENT are reproductive, maternal, neonatal, child and adolescent health (RMNCHA), communicable and noncommunicable diseases, nutrition, mental health, environmental health, health system research, healthcare financing, digital health, occupational health, vulnerable people’s health and oral health.

The clinical trials to be conducted by INTENT partners can be grouped as short, intermediate, and long-term projects. To begin with, the focus of the network will be on short-term projects, where questions relevant to national health needs can be answered within 1-2 years. The projects will be primarily funded by ICMR.

Interested parties should fill the Google form at the following link:
https://docs.google.com/forms/d/e/1FAIpQLSf6yt0HbP0vfJswup8q8nHRt5b1omYX8iQNWt
GEN8aSd3VjaA/viewform?usp=sf_link

The last date of receiving application: 25th October 2021

For further information, please contact:

Dr. Aparna Mukherjee
Scientist E
Clinical Studies Trials & Projection Unit
Epidemiology and Communicable Diseases Division
Indian Council of Medical Research
Email: intent.icmr@gmail.com
Mob: +919968408999

Source : https://main.icmr.nic.in/sites/default/files/upload_documents/EoI_INTENT_v1.pdf

BA BE Centres Regn Process

CDSCO Announcement – BA BE Centres to apply online for Registration Process

CDSCO to move application process for registration of centers for BA/BE studies online from Oct 15 2021

CDSCO has released a notification recently on registration process for BA/ BE Centers.

The National Drug Regulator has switched the applications for registration of bioavailability/bioequivalence (BA/BE) studies from the industry, from physical to digital from the middle of this month – 15th Oct 2021. This is in line with the Central Drugs Standard Control Organisation’s (CDSCO) efforts to implement an e-governance mechanism in the organisation.

The Drugs Controller General (India) Dr V G Somani, in a notice, said that the CDSCO, in collaboration with Centre for Development of Advanced Computing (CDAC), has developed a module for online processing of applications for registration of BA/BE study centres in accordance with New Drugs and Clinical Trial Rules, 2019.

The module is finalised and has been made functional, which can be accessed through the dedicated website of CDSCO. The drug regulatory also requested all concerned stakeholders to avail the facility and welcomed any comments or suggestions to help improve the module.

“Thereafter, the BA/BE centre registration applications processing will be online and physical applications may not be accepted after October 15, 2021, in this regard,” said the notice.

The move comes as CDSCO’s efforts to implement the e-governance mechanism with various online services launched through the Sugam portal on November 14, 2015.

On September 30, the CDSCO has said that the submission of applications on Post Approval Changes in bioavailability (BA)/bioequivalence (BE) study permission and import license for export purpose is functional on online system of Sugam portal, in order to streamline the regulatory submission procedure.

“The facility of offline submission of applications in hard copy or through e-mail may not be available after October 8, 2021, for processing,” said a notice, issued to all stakeholders, State and Union Territory Licensing Authorities and others.

The Sugam e-governance portal has been designed as a single window system for all the stakeholders to access the services provided by the portal, by implementing role based access control and actions. It has consolidated the entire drug regulatory framework at centre and provides a centralised dashboard for monitoring various regulatory clearances all over the country.

The portal is well integrated with the e-Nivesh that is the National portal to provide the project proponent/entrepreneur with all requisite information under one umbrella, which will reduce delays in various regulatory processes. SUGAM enables ease of business by providing the integrated workflow right from making an application for grant of permission/ license, online payment, online review process, query management and grant of permission/license online. Sugam portal internally builds the database of drugs & manufacturers and their current regulatory status (approved/ banned) in India, according to C-DAC, which created the portal.

Source : http://www.pharmabiz.com/NewsDetails.aspx?aid=143001&sid=1

CDSCO Notification

Download the Notification from CDSCO here

Medical Device QMS

NABCB Program on MDQMS – Medical Device Quality Management Systems

Program Announcement from NABCB !

NABCB is organising series of webinars on “Medical Devices Quality Management Systems (MDQMS) and Indian Certification for Medical Devices (ICMED) Scheme”

There is no fee for the said Webinar. The Webinar is scheduled on 20 October 2021 at 11:00AM – 01:00 PM (IST)

This webinar would provide an interface wherein you may directly interact with NABCB Officials about NABCB Accreditation system and other requirements, so your participation would make the webinar interesting and fruitful.

Registration link is https://forms.gle/Qg2Z55iYc6oNWKnv7

The flyer is available on link  http://nabcb.qci.org.in/Meeting%20%20flyer%20-%20MDQMS%20%20ICMED-%2020%20October%202021.pdf

Meeting Link shall be provided to all the registered participants a day before the scheduled date.

Contact NABCB Secretariat :
National Accreditation Board for Certification Bodies
Quality Council of India | www.qcin.org
Institution of Engineers Building, 2nd Floor,
2, Bahadur Shah Zafar Marg, New Delhi – 110002, India
Work: +91-11-2337-9321 | Fax: +91-11-2337-8678
Facebook | Linked In Twitter

Notification from CDSCO

Fresh Notification – Voluntary Registration & Labelling Norms from CDSCO for Medical Device Industry

CDSCO has released a fresh notification dated 12th October, 2021 clarifying its stand on Voluntary Registration and Labelling norms to be followed by the Medical Device Industry. CDSCO has called for feedback , suggestion from the industry to the proposed amendments.

Industry and stakeholders are requested to share feedback to CDSCO office, the details are listed in the notification below.

NOTIFICATION – New Delhi, the 12th October, 2021

G.S.R. 729(E).—The following draft of certain rules further to amend the Medical Device Rules, 2017, which the Central Government proposes to make, in exercise of the powers conferred by sub-section (1) of section 12 and sub-section (1) of section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940) and in consultation with the Drugs Technical Advisory Board is hereby published for information of all persons likely to be affected thereby and notice is hereby given that the said draft rules shall be taken into consideration on or after the expiry of a period of seven days from the date on which copies of the Gazette of India containing these draft rules are made available to public;

Objections and suggestions which may be received from any person within the period specified above will be considered by the Central Government;
Objections and suggestions, if any, may be addressed to

The Under Secretary (Drugs Regulation),
Ministry of Health and Family Welfare, Government of India, Room No. 434, C Wing, Nirman Bhavan,
New Delhi – 110011
or
emailed at – drugsdiv-mohfw@gov.in.

DRAFT RULES

(1) (i) These rules may be called the Medical Devices (……Amendment) Rules, 2021.
(ii) These rules shall, unless specified otherwise, come into force on the date of their final publication in the Official Gazette.

(2) In the Medical Devices Rules, 2017(hereinafter to be referred as said rules), in rule 19B, in subrule(2), in item (iii), at the end, the following Proviso and Explanation thereto shall be inserted, namely:—

“Provided that in case the applicant submits, on or before the 30th November, 2021, an undertaking that applicant shall obtain the ISO 13485 certificate on or before the 31st May, 2022 in lieu of certificate of compliance as referred in clause (iii) of sub-rule (2) of rule 19B, a provisional registration number shall be generated which will remain valid up to the 31st May, 2022 or the date on which the applicant obtained such ISO certificate whichever is earlier. The said generated provisional registration number shall be valid for all purposes.

Explanation.— For the removal of doubt, it is hereby declared that in case of such ISO 13485 certificate not obtained before the 31st May, 2022 as per undertaking referred in the Proviso by the applicant the provisional registration shall be deemed to have been cancelled for all purposes
without any notice.”

(3) In the said rules, in rule 19C, for the words “shall mention the registration number” the following words, letters and figures shall be substituted, namely:—

“may, if so desired, mention the registration number or provisional registration number, as the case may be, for a period up to the 31st May, 2022, thereafter it shall be mandatory for all registration holders”.

(4) In the said rules, in rule 19D, in sub-rule(2), in item (iii), at the end, the following Proviso and Explanation thereto shall be inserted, namely:—

“Provided that in case the applicant submits, on or before the 30th November, 2021, an undertaking that applicant shall obtain the ISO 13485 certificate on or before the 31st May, 2022 in lieu of certificate of compliance as referred in clause (iii) of sub-rule (2) of rule 19D, a provisional registration number shall be generated which will remain valid up to the 31st May, 2022 or the date on which the applicant obtained such ISO certificate whichever is earlier. The said generated provisional registration number shall be valid for all purposes.

Explanation.— For the removal of doubt , it is hereby declared that in case of such ISO 13485 certificate not obtained before the 31st May, 2022 as per undertaking referred in the Proviso by the applicant the provisional registration shall be deemed to have been cancelled for all purposes
without any notice.”

(5) In the said rules, in rule 19E, for the words “shall mention the registration number” the following words, letters and figures shall be substituted, namely:—

“may, if so desired, mention the registration number or provisional registration number, as the case may be, for a period up to the 31st May, 2022, thereafter it shall be mandatory for all registration holders”.

Download the Notification from CDSCO

Source : CDSCO

Voluntary Registration

Voluntary Registration of Medical Devices & Labelling Norms – Medical Device Sector – Fresh Announcement from CDSCO

Medical Device Industry has recently sent a representation to the Regulator – CDSCO, to consider timeline extensions to the Voluntary Registration Program announced by the Regulator in April 2020. Though the 18 months timeline offered by the Regulator came to an end on Sep 30th 2021, many MSME businesses couldn’t complete the process . Regulator has forwarded the request to Ministry . A Session with Regulator organized by industry was attended by more than 1000 members and industry and various other key stakeholders raised many pertinent issues requesting the regulator’s office to look into. One of the key issues raised during industry meet was ISO 13485 Certification process and challenges in completing the exercise to obtain “Authentic ISO 13485 Certificates” .

Industry is waiting for further instructions from Regulator’s office on the timelines extension to the Voluntary Registration Process.

Fresh Notification from #CDSCO

CDSCO has released a fresh notification dated 12th October, 2021 clarifying its stand on Voluntary Registration and Labelling norms to be followed by the Medical Device Industry. The announcement is more specific to ISO 13485 Certificates and the Self declaration to be given by Industry to Regulators about the roadmap to complete the certification process.

CDSCO has called for feedback , suggestion from the industry to the proposed amendments. Industry and stakeholders are requested to share feedback to CDSCO office, the details are listed in the notification.

Download the notification from here

Request the industry, stakeholder to share feedback with Regulators, Industry Associations etc to the proposed amendments.

FAQs Session With CDSCO

Medical Device Regulations – Non Notified Devices – Voluntary Registration ProcessSeptember 19th 2021, Sunday – 4 PM – 5 PM

Let Our REGULATOR Speak to You !

Do Join Us to get answers to your FAQs on Voluntary Registration Process !

Voluntary Registration Process rolled out by CDSCO for Non Notified Devices is coming to an end by Sep 30th 2021. Industry Forums are receiving so many FAQs from various stakeholders over the last 2 months asking many questions on Voluntary Registration Process and raising wide range of questions on WHAT HAPPENS FROM OCTOBER 1ST 2021.

Hence AIMED (Association of Indian Medical Device Industry) is organising a session to enable the industry, stakeholders to get their FAQs addressed from the Regulator.

Some of the FAQs raised by stakeholders are captured below and we invite industry, stakeholders to register and join the session to discuss pertinent issues , challenges faced, if any.

This program is the initiative of AIMED , a leading Industry Platform for Make in India Manufacturers representing the Voice of the Industry.

Program Information :

Some FAQs from Industry which need information from CDSCO :

Registration Details :

Who Should Attend ?

Program is Open for all Industry Members, Stakeholders like Manufacturers, Traders, Distributors, Startups, Med Tech Businesses etc.

There is NO REGISTRATION FEE but Prior Registration is a MUST.

Registered Participants shall get Email Confirmation 2 days before the session from Consultants Consortium of Chennai .

Registration Link

Download the program collaterals from here

Contact Co-ordinates :

Ms Rama Venugopal
Email – contact@ccc-consultants.org
WhatsApp – +91 9840870532

Mr D Srikanthan
Email – secretariat@ccc-consultants.org
WhatsApp – +91 9003056539

Clarification on the Role of NABL in Enforcing Regulations

Announcement from NABL – National Accreditation Board for Testing and Calibration Laboratories

Clarification on the Role of NABL in Enforcing Regulations

Accreditation is the independent evaluation of Conformity Assessment bodies against recognised normative documents like Standards, Regulations etc. to carry out specific activities to ensure their impartiality, consistency of operation and competence. Through the application of national and international Standards, Government, Procurers and Consumers can have confidence in the results of accredited Conformity Assessment Bodies.

Laboratories are accredited to the applicable international standards, ISO/IEC 17025 in case of testing and calibration laboratories, and ISO 15189 applicable to Medical Laboratories.

Laboratory Customers, Regulatory Authorities, Organizations and Schemes using peer assessment, Accreditation bodies, and others use these documents in confirming or recognizing the competence of laboratories.

The results from Accredited Laboratories are used extensively by regulators for the public benefit in the provision of services that promote an unpolluted environment, safe food, clean water, energy, health and social care services.

Many Government Agencies have recognised the importance of credible accreditation schemes that are developed against internationally recognised standards.

NABL Accreditation is increasingly being used by Regulators and Government to ascertain the Quality of Products. Accredited CABs can objectively state conformance of product or service to specified requirements.

NABL is a Voluntary Accreditation body and has no Regulatory powers. Checking of compliance to the regulatory requirements falls under the purview of respective/applicable Regulator.

In all cases, it is the responsibility of Laboratory to abide by the National & State Statutory requirements, Acts, Ordnance, Rules, Regulations, Legal orders, Court Decisions/ Orders issued by the Government, Statutory Bodies, Courts as applicable and in force from time to time.

Download the announceement from here

Source : https://nabl-india.org/

The above announcement from NABL clarifies its role as Accreditation body to various stakeholders at market place. Regulators , Governments normally rely on Accreditation Bodies for Conformity Assessment procedures. Accreditation bodies are not Regulators and can’t step into shoes of Regulators. This confusion is often seen at market place where Accreditation bodies and Regulators Roles are understood wrongly , get mixed up often. Frequent communication from Apex bodies , Accreditation bodies clarifying the role of ABs, CBs etc throws so much clarity to the industry, stakeholders too. Markets still mix up Accreditations and Certifications. Lot of confusion prevails between Voluntary Recognition Programs and Mandatory Recognition Programs. FAQs list is very long and apex bodies can release communication often on all the FAQs.

Improving Global Competitiveness of Indian businesses is the key focus of Govt of India and businesses need to show compliance to various Conformity Assessment Procedures of Importing Countries. Understanding all these matter as most of these protocols are International Protocols too.

Country is witnessing lot of FDI and many new global businesses are setting up shop in India. International businesses need clarity and clear communication on conformity assessment too as Technical Regulations are linked to International Accounting Standards as well.