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

QCI NBQP Programs

Upcoming Training Programs from QCI TCB , NBQP

Update from QCI TCB :

Training and Capacity Building (TCB) Cell, QCI has announced new batches of virtual training for the months of November & December 2021. Please check program calendar as listed below :

Requirements of ISO/IEC 17065:2012 for Product Certification Bodies 29-30 Nov 2021 Registration   Open INR 5000 +GST 
Laboratory System and Internal Audit program as per ISO/IEC 17025:2017$$ 19-20 Oct 2021  25-26 Nov 2021 Registration Closed INR 5000/-   + GST (18%)  
06-07 Dec 2021Registration   Open 
ISO/IEC 17025:2017 – Risk Management requirements & implementation in Laboratories 15 Nov 2021 Registration Closed INR 2000/-   + GST (18%) 
22 Dec 2021 Registration   Open 
Uncertainty of Measurement and Decision Rule as per ISO/IEC 17025:2017 26-27 Oct 2021 16-17 Nov 2021 Registration Closed  INR 3500/-   +GST (18%)  
22-23 Nov 2021 Registration   Open  
Medical Laboratory System and Internal Audit program as per ISO 15189:2012$$  11-12 Nov 2021 Registration   Open INR 5000/-   +GST (18%)  
Lean Six Sigma Green Belt Certification 28-30 Oct 2021 Registration   Open INR 9500/-   +GST (18%)  

$  eLearning modules for these courses are also available at www.equest.co.in . Once you complete both the courses, you will get an additional ‘Competence Certificate’

The courses are designed for professionals like quality & senior management professionals from Inspection Bodies, Laboratories, Certification Bodies, Regulators, Government Bodies, Industry, PSUs, Consulting Organizations, Consultants, Training Organizations, Trainers etc. 

To deliver quality engagement, only limited number of participants are allowed for the training courses , to give sufficient opportunities for participants to participate in discussions and to clarify their doubts. 

After the completion of the course, all the participants will be issued a certificate of participation. 
Utilise this opportunity to register yourself.
We have launched various other trainings in the general domain as well as listed below :

Cost of Quality – A tool for developing Business Case for Quality Improvement Initiatives 9 November’21 
Fundamentals of Digital Marketing  18 November’21 
Organizational Values, Ethics & Office/Work Place Etiquettes 4 December’21 

Register yourself at the earliest by clicking on the link- http://bit.ly/virtualequest 

On eQuest (www.equest.co.in ), an array of courses on domains such as Environment, Laboratories, Quality, Agriculture, Healthcare, and Technology-related fields etc are listed.

A new course developed by NABL on ‘Program for Potential / Accredited / Applicant Proficiency Testing Providers on ISO/IEC 17043:2010” was launched recently . This program is designed for PT Providers to know about standard ISO/IEC 17043:2010 “Conformity Assessment – General requirements for the proficiency testing”.  

For registration and payment related queries, please contact,  
Rohit Varshney, Associate, TCB, QCI, rohit.varshney@qcin.org, Ph- 9773500376 

For any other queries, please write to  
Alok Jain, Director TCB, QCI, ajain@nabl.qcin.org, Ph. 9811352698  
Ranvijay Bihari, Dy Director, TCB, QCI, ranvijay.nabet@qcin.org, Ph. 8800424788 

Laboratory Excellence Award

Prof. S.K. Joshi Laboratory Excellence Award from QCI NBQP

Prof. S.K. Joshi – Laboratory Excellence Award has been instituted to promote Laboratory Quality and performance improvement in the country. The award has been incepted to ensure the laboratory’s commitment to achieve excellence in providing high precision testing and calibration services in line with the prevalent national/international quality systems legislations including Health, Safety, Environment (HSE).

The Award is to recognize Laboratories (Testing, Medical and Calibration) those have established outstanding achievements in the field of Quality in services and benchmarked in their domain for their best practices

Eligibility:

1.This award is open to all currently operational Laboratories pertaining to Testing, Calibration & Medical including their Proficiency Testing Providers & Reference Material Producers located in India.
2.Participating labs are required to operate the applicable Quality System according to the requirements as stipulated in ISO 17025/ISO 15189/ISO 17043/ISO 17034, regarding its implementation and monitoring.
3. The award require labs to operate with proper HSE measures.
4.The Laboratory should not have been convicted by any Court.
5.A Laboratory once awarded can be considered only after a period of 3 Years

The 5 stages of assessment by Technical Expert Committee (TEC) are as follows:-

Stage 1: Application Document Evaluation
Stage 2: Physical/Virtual Presentation
Stage 3: Site Assessment / verification
Stage 4: Evaluation through Reference check of customer in special case
Stage 5: Inputs to Jury for final evaluation

Assessment Criteria

The assessment of the application submitted by the laboratory is made on the basis of various parameters which have been identified by a team of experts from NBQP/QCI.

Primary Parameters:

  1. Management Commitment – Qualification, Experience, Training & Innovation, Quality Improvement and skill upgradation.
  2. Strategy – Accreditation for entire Laboratory activities (to ensure Sustainability).
  3. Processes – Standard Method (National/International), Validation/Verification, Equipment/Techniques used and Measurement Traceability to SI units.
  4. Infrastructure & Quality Control Resources – Facilities and Environmental Conditions (Innovation for enhancing Good Laboratories Practices) owned by Lab. Use of Certified Reference material, Proficiency Testing Program participation and Inter-Laboratory Comparison and other QC checks.
  5. Customer Complaints, Feedback and Improvement – Diagnosis of the problem (Root Cause Analysis & Quality tools deployed)
  6. Key Results/Satisfaction – Reports, Customer Results, Society Results and Employee Satisfaction. Tangible benefits, intangible benefits or socio economic and environmental benefits

Terms & Conditions Of The Award:

1. Non – disclosure and confidentiality
I. The names of the applicants, evaluation and scoring system developed for the assessment process will be regarded as proprietary and kept confidential. Such information shall be made available only to those individuals who will be directly involved in the assessment and administrative process and shall not be disclosed.
II. QCI will not disclose the details about the shortlisted/non-shortlisted laboratories at any stage of the assessment. The qualified laboratories will be notified via e-mail/call by the QCI office directly.
2. Any misinterpretation of facts will disqualify the laboratories from Awards.
3. Applications received with incomplete data will not qualify.
4. Any Award applicant and Awardee cannot use the NBQP and QCI logo in anyway that suggests that QCI is affiliated with, sponsors, approves or endorses you, your organization, your websites, your products or your services etc.

Application Fees

There is no Application Fees

Award Presenatation

The awards will be presented during a special Award Ceremony

Where to Apply ?

Award Details

check here to know more about various awards and details

When is the Last date for applying ?

Last date for submitting the application form is 16th November 2021

For any queries, contact :

Source – https://labexcellenceaward.qcin.org/Home.aspx

Fee Update from NABL

Revised Fee Structure effective for all applications received on/after 01.10.2021 Posted on 01.10.2021

NABL has released revised Fee Structure for all applications received on or after 1/10/2021 . This is applicable for all Testing and Calibration Labs.

All applicant labs and Accredited, Certified Labs have to make a note of the same.

Download the notification from 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

Good Clinical Practices Training

Awareness Programme For Training Institutions on Good
Clinical Practice Professional Certification Scheme (GCPPCS)

About CDSA

Department of Biotechnology (DBT), Ministry of Science & Technology, Government of India launched CDSA on 28 September 2009 as an extramural unit of Translational Health Science & Technology Institute (THSTI). It was created to facilitate development of affordable healthcare products for public health diseases. Registered as a not-for profit research organization, it aims to develop an eco-system for training and learning and work with public sector institutions, and small and medium enterprises (SME) to translate innovative technologies into medical products for public good.

About GCPPCS

There is an ever-growing demand for trained and certified Good Clinical Practice (GCP) professionals in the clinical research arena both in academia and in industry. Setting up an uniform system to achieve the desired competence standard using internationally accepted best practice for ‘Assessment’ and ‘Certification’ is the key to addressing this unmet need.

To this end, a Certification Scheme for GCP professionals based on the International ‘Personnel Certification’ standard (ISO 17024:2012) has been developed by CDSA-THSTI.

The GCP professional certification scheme has  two aspects – a system of accreditation of Training Institutions to ensure standardised, high-quality GCP training and  GCP Professionals Certification (by Third-Party Certification) to promote certification of professionals both within the country and across the globe.

GCPPCS is owned by the Clinical Development Services Agency (CDSA)-Translational Health Science & Technology Institute (THSTI). THSTI is an autonomous institution under the Department of Biotechnology, Ministry of Science & Technology, Government of India. CDSA-THSTI as Scheme Owner,  has the Steering Committee, Technical Committee and Assessment Committee to draft, review and approve the relevant documents and  effective implementation of the Scheme.  These committees are comprised of multiple stakeholders for example subject and process experts with representatives from ministries, regulator, government agencies, industry, academia, accreditation body, certification body, training institutions and civil society organisations.

Upcoming Program on GCPPCS :

CDSA has successfully completed two webinars for creating awareness and generating interest amongst the Personnel Certification Bodies, Training Institutions and individual GCP professionals for the Good Clinical Practice Professional Certification Scheme (GCPPCS) on September 22 and October 6, 2021.

The next webinar, specifically designed for the Training Institutions, is scheduled for October 20, 2021 from 1400 hrs. Prof Y K Gupta would be delivering the Opening Remarks.

S.NO.DATESPEAKERTOPICRELATED MATERIALREGISTRATION LINK
1October 20,2021Prof. Debjani Roy
Dr. Harish Nadkarni Maheshwari
Dr. Sanish Davis
Dr. Sucheta Banerjee Kurundkar
Mr. S Krishnamurthy
Prof. Y.K Gupta
Awareness Programme For Training Institutions on GCPPCSProgram FlyerRegistration deadline: October 18, 2021

Registration Form

CDSA invites participation from Healthcare Services Sector to explore opportunities to be the Training Partners for this program. Attending this webinar will throw more light about the GCPPCS Program.

For further information, please contact us at gcppcs.cdsa@thsti.res.in 

प्रो. देबजानी रॉय/Prof. Debjani Roy
सदस्य सचिव और कार्यक्रम प्रबंधक, जीसीपीपीसीएस /Member Secretary & Program Manager, GCPPCS – Clinical Development Services Agency Translational Health Science & Technology Institute, 
Department of Biotechnology, Ministry of Science & Technology, Government of India
NCR Biotech Science Cluster, 3rd Milestone, Gurgaon- Faridabad Expressway, Faridabad 121001
क्लिनिकल डेवलोपमेंट सर्विसेस एजेंसी, ट्रांसलेशनल हेल्थ साइंस एंड टेक्नोलॉजी इंस्टिट्यूट,
विज्ञान और प्रौद्योगिकी मंत्रालय, भारत सरकार
Tel: +91-41052296,
Email: debjaniroy.cdsa@thsti.res.ingcppcs.cdsa@thsti.res.in

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

OKRs Focus in Businesses

Webinar on OKRs – Growth Strategy for your Business Sep 17th 2021 – Friday – 3PM – 4PM

“Ideas are Easy. Execution is Everything” – John Doerr

How OKRs help 1000s of companies accelerate growth

O – Objectives
K – Key
R – Results

What is OKR ?

Objectives and Key Results (OKR) are a goal-setting framework that helps organizations define goals — or objectives — and then track the outcome.

OKR is a concept widely accepted in the digital landscape as well as offline market to inspire and motivate their employees. It answers the major questions like:

  • Where do I want to go?
  • How do I pace myself to see if I am getting there?

OKRs provide organizational focus to teams and help in drastically improving productivity.

Download a brief note on OKR to understand a little about the same :

Session Focus

How to introduce OKRs for your Organization?
– A Case Study Presentation

Target Audience

CXOs / Founders / Chief of Staff / Strategy Leaders

Program Agenda

Speaker Session – 40 minutes
Q & A – 20 minutes

Webinar Outcome

  • What are OKRs ?
  • Why are OKRs being adopted by CXOs globally?
  • A case study presentation – An OKRs implementation story

Registration

No Registration Fee but prior registration is a must.

Registered Participants shall get confirmation mail 2 days before the program.

Registration Link :

Contact Co-ordinate

D C Sriram
RVK Business Advisory Services P Ltd
Email – contact@virtualadvisor.in
WA – +91 9150061418

Download Program Brochure

Virtual Advisor on Social Media

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