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.

Scheme for promotion of ‘Medical Device Parks’

Centre Notifies Scheme for Promotion of ‘Medical Device Parks’

Scheme for “Promotion of Medical Device Parks”, a key initiative to support the medical devices, notified.

With Financial Outlay of Rs. 400 crore, the Scheme aims to significantly reduce manufacturing cost, optimize resources, build on economies of scale and provide easy access to standard testing and infrastructure facilities

Himachal Pradesh, Tamil Nadu, Madhya Pradesh and Uttar Pradesh given “in-principle” approval to set-up Medical Device Parks under the scheme
.

In a bold move that would make India ‘Aatmanirbhar’, the Government of India has taken a key initiative to support the medical devices industry to reach its potential in the coming years identifying the industry is as a sunrise sector with great potential for diversification and employment generation. Recognizing the need for higher levels of investments for the creation of proper infrastructure in the sector, the Department of Pharmaceuticals has notified the Scheme for “Promotion of Medical Device Parks” with the following objectives :

  • Easy access to standard testing and infrastructure facilities through creation of world class common infrastructure facilities for increased competitiveness will result into significant reduction of the cost of production of medical devices leading to better availability and affordability of medical devices in the domestic market.
  • Reaping the benefits arising due to optimization of resources and economies of scale.

The Medical Devices Parks to be developed under the scheme will provide common infrastructure facilities at one place thereby creating a robust ecosystem for the medical device manufacturing in the country and also reducing the manufacturing cost significantly. The total financial outlay of the scheme is Rs. 400 crore and the tenure of the scheme is from FY 2020-2021 to FY 2024-2025. The financial assistance to a selected Medical Device Park would be 70% of the project cost of common infrastructure facilities. In case of North Eastern States and Hilly States, financial assistance would be 90% of the project cost. Maximum assistance under the scheme for one Medical Device Park would be limited to Rs. 100 crores.

In total, proposal from 16 States/UTs were received under the scheme. The selection of the States/UTs is based on the challenge method, which is reflected in the evaluation criteria of the scheme. The ranking methodology for States/UTs is based on the parameters prescribed in the scheme guidelines such as utility charges, State policy incentives, total area of the park, land lease rate, connectivity of the park, ease of doing business ranking, availability of technical manpower etc. Based on the evaluation, the proposals of State Government of Himachal Pradesh, Tamil Nadu, Madhya Pradesh and Uttar Pradesh have been given “in-principle” approval under the scheme. Further qualitative assessment of the said States in terms of their fiscal capability, ecosystem attractiveness and industrial presence also validated the selection of these States.

The scheme reflects the spirit of co-operative federalism where the Central Government and State Governments will partner to develop the Medial Device parks for better performance of the sector. 

Source – https://pib.gov.in/PressReleseDetail.aspx?PRID=1757662

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

https://www.youtube.com/channel/UC5_HedmdImYZ-9hxgv27LYg/featured

https://www.facebook.com/glocaladvisor

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.

TiE Mumbai’s Healthcare Summit

IIMPACT 2021 – 16th & 17th September 2021

TiE Mumbai’s Healthcare Summit IIMPACT 2021

GLOBALLY, HEALTHCARE & HEALTHTECH has been amongst the top 5 sectors to scale successfully to unicorn status 

Healthcare companies globally have cumulatively raised over USD 10 Bn over the last decade. They represent a vast variety of companies – from regenerative medicine, drug development, online physician service, appointment booking, health insurance, wellness apps, amongst others. Healthcare superstars have emerged from pretty much across the globe such as US, China, UK, Germany, Israel, France and South Korea. 

Simultaneously, the start-up landscape in India has matured significantly as well. Several Indian start-ups across sectors have managed to scale successfully, with more start-ups joining the vaulted Unicorn club in 2020 alone. 

Indian healthcare start-ups, have now started to see the scale of success, it, has been a great year for Indian healthtech, with Pharmeasy -becoming India’s first healthtech unicorn, and Krsnaa Diagnostics – a teleradiology player, getting a successful IPO 

What does it take to build scalable healthcare innovation in India ?

 IIMPACT Health 2021 looks at this question closely by curating the best minds in global healthcare. 

We look at the core issue healthtech start-ups face – scaling successfully – and bring together Thought Leaders, VCs, successful Indian and global healthcare & healthtech entrepreneurs, to decode what it takes to build a large, successful, healthcare company in India 

To understand opportunities in Healthcare, IIMPACT 2021 is an event you cannot afford to miss!

Event Details:

Date: 16th – 17th Sept 2021

Time: 5:30 PM – 8:30 PM IST

Mode: Online (zoom)

Source –

https://hub.tie.org/e/global-shift-disruptions–age-of-unicorns–scaling-healthcare-innovation-in-india

CAHOTECH2021

6th Annual Health Technology Conference from CAHO ! Connecting Healthcare & Technology

About CAHOTECH

CAHOTECH offers a unique platform for healthcare providers to learn about disruptive technological advancements and futuristic trends. The event focuses on scalable technology solutions to make modern healthcare accessible, available, efficient and affordable to all. 

Over the years, CAHOTECH has connected hundreds of technology companies to thousands of healthcare organizations, introduced our healthcare partners to newer methods and technology to improve their quality and efficiency of care, and highlighted the best practices in making such purchases – ensuring that there is information sharing among consumers of healthcare technology in a fast-evolving market that is hard to keep track of.

Since 2020, the pandemic has transformed the event into a virtual event. We believe that such a transformation, though with its own flaws, also allows more people to attend the sessions with convenience and comfort. We are also able to get a larger base of speakers and ideas and this transformation into a virtual event is turning out to be a blessing in disguise.

2021 Edition

CAHOTECH 2021 is a 5 days virtual event, starting with the PitchFest and Hospital Innovations Showcase on 13th and 14th August respectively. The 3 days main conference sessions (brochure enclosed) will be from 3 pm to 7 pm on the following themes:

19th August: Scaling Technology Adoption

20th August: Digital Transformation in Healthcare

21st August: Interconnected Healthcare Ecosystem

Event Update at a glance :

Program Agenda

Download the full program agenda from here

Registration Details :

For delegate registration, here is the link to register –

https://www.caho.in/cahotech2021/

Already Registered Delegates Access to Conference :

CAHOTECH Conference Platform :
Delegate Access Link –
https://CAHOTECH-2021.hubilo.com/community
Please login with your registered email id.

For any login related queries, you may contact
Ms. Anitha Sudhakar @ +91 – 7904146046
Ms. Preetha Thangarajan @ +91- 7010549358

CAHOTECH Conference Platform :

Sponsors/ Exhibitors/ Partners Access Link –
https://CAHOTECH-2021.hubilo.com/community
Have to login with email ids registered with us.

For any virtual booth related queries, contact –

Mr. Prakash Sati @ 8130770805
Ms. Revathi @ 7428892074

For all latest updates about daily programs, speaker profiles, sessions etc, visit –

https://cahotech.com/day-1-scaling-technology-adoption/

https://cahotech.com/day-2-digital-transformation-in-healthcare/

https://cahotech.com/day-3-interconnected-healthcare-ecosystem/

DO REGISTER TODAY & JOIN US !

CAHOTECH2021 Conference

Connecting Healthcare and Technology – 19th – 21st Aug 2021

DELEGATE REGISTRATION CALL

Delegate Registration Link

About CAHOTECH

CAHOTECH offers a unique platform for healthcare providers to learn about disruptive technological advancements and futuristic trends. The event focuses on scalable technology solutions to make modern healthcare accessible, available, efficient and affordable to all. 

Over the years, CAHOTECH has connected hundreds of technology companies to thousands of healthcare organizations, introduced our healthcare partners to newer methods and technology to improve their quality and efficiency of care, and highlighted the best practices in making such purchases – ensuring that there is information sharing among consumers of healthcare technology in a fast-evolving market that is hard to keep track of.

Since 2020, the pandemic has transformed the event into a virtual event. CAHO believes that such a transformation, though with its own flaws, also allows more people to attend the sessions with convenience and comfort. CAHO is also able to get a larger base of speakers and ideas and this transformation into a virtual event is turning out to be a blessing in disguise.

2021 Edition

CAHOTECH 2021 is a 5 days virtual event, starting with the PitchFest and Hospital Innovations Showcase on 13th and 14th August respectively. The 3 days main conference sessions (brochure enclosed) will be from 3 pm to 7 pm on the following themes:

19th August: Scaling Technology Adoption

20th August: Digital Transformation in Healthcare

21st August: Interconnected Healthcare Ecosystem

For more information about CAHOTECH, visit

https://cahotech.com/

Contact Help Desk :

CAHO Secretariat
G-100, Sector-44, Noida
Uttar Pradesh – 201301Helpdesk:+91 9870318781

Hours:
Monday to Saturday, 09:00 to 20:00

CAHOTECH 2021

CAHOTECH STARTUPS PITCHFEST Session is rolled out !

Pitchfest for HealthTech / MedTech / Digitech Startups

Last date for Application – 10th August 2021
Pitch Date : 13th August 2021

Startups to register pitches here
https://www.caho.in/cahotech2021/registration/pitchfest.php

About the Event :

CAHOTECH is the annual healthcare technology conference, engaging with stakeholders to share the concepts & ideas leading the way for early and better adoption of technology in healthcare sector

CAHOTECH is giving an opportunity to startups to showcase their Innovations to leaders in the healthcare ecosystem (comprising CxOs, Angel Investors, Incubators and other stakeholders), who will co-create the future of healthcare with Startups.

PITCHFEST Brochure

Call for Sponsorships !

CAHO is inviting Industry and Industry Stakeholders from Healthcare Sector to support and encourage the Pitchfest by Sponsoring the Pitch Fest / Booking Virtual Stalls for Pitchfest Session. This is the Call of Action given to encourage Startups in healthtech, medtech, digitaltech space in healthcare products and services sectors.

Sponsorship Brochure

More details on Sponsorship and Partner benefits are listed in the portal

https://cahotech.com/partners-sponsors/

For more details, information, contact team here :

https://www.caho.in/contact-us

Medical Device – Product Recall

Ventilator Recall by Philips – Recall Announcement / Alert from CDSCO

Medical Device Alert on Ventilator of Philips Announcement from CDSCO

Following message is shared by National Coordination Center (NCC) –Materio vigilance program of India(MvPI)Indian Pharmacopoeia Commission(IPC), Ghaziabad, Autonomous body of Ministry of Health and Family Welfare, Govt of India:

Dear Healthcare Professionals,

As CDSCO has issued Medical Device Alert on Philips Ventilator, kindly go through the link shared below to know more about the alert :

https://cdsco.gov.in/opencms/opencms/system/modules/CDSCO.WEB/elements/download_file_division.jsp?num_id=NzM3MQ==

Kindly update NCC MVPI team whether the said ventilator make is available/used in your hospital premises.

If yes, kindly send the feedback to the following email ids, by submitting duly filled “Field Safety Correction Action Form” shared below :

https://www.ipc.gov.in/images/FIELD_SAFETY_CORRECTIVE_ACTION_NOTIFICATION_FSCA_FORM.pdf

Please email your feedback along with duly filled field safety form to :

Kindly request your hospital team to take immediate necessary action as mentioned in alert notice.

Downloads :

About CDSCO – https://cdsco.gov.in/opencms/opencms/en/Home/

About IPC – https://www.ipc.gov.in/

About MVPI Program Launched by IPC :

Ministry of health and family welfare, Government of India has approved the commencement of Materiovigilance Programme of India (MvPI) at Indian pharmacopoeia commission on July 6, 2015 to monitor the safety of medical devices in the country. Indian Pharmacopeia Commission is functioning as National coordination center for MvPI and various steps and strategies have been made by NCC including launching of reporting tools to report MDAE, enrollment of new Medical Device Adverse Events Monitoring Centers and many others are in pipeline.

Training and workshops are organized in different regions of the country to improve the adverse event reporting practice and the attitude of healthcare professionals. NCC in collaboration with Central Drug Standard Control Organization, National Health System Resource Centre and Sree Chitra Tirunal Institute for Medical Sciences and Technology provides training and technical support to the stakeholders and this guidance document will be an important tool for conducting Materiovigilance activities. We are hopeful that this document will support to ensure
the safety and efficacy of medical devices in the country by illuminating various components of MvPI.

For more information about MVPI, download the document below :

Role of Hospitals and other Healthcare Organisations in reporting Adverse Events to IPC :

Hospitals and other Healthcare organisations have to report adverse events caused by drugs or devices to IPC under PVPI or MVPI program.

Since many of the Hospitals and Healthcare organisations are Certified , Accredited for many Quality and Patient Safety Programs in the country , Certification or Accreditation Programs calls for mandatory reporting of Adverse Events caused by Drugs or Devices to Patients, Employees etc.

Since the Ventilator is Recalled by the manufacturer on “Health and Safety Grounds”, Healthcare organisations which have been using the cited make of the Ventilator have to share the feedback to MVPI Cell of IPC in the format shared above. These are the Globally defined Regulatory Protocols and all healthcare organisations have to follow the same.