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.

Women Entrepreneurship Seminar – Hybrid Event

Best practices among SAARC Countries – Seminar from Andhra Chamber of Commerce along with FRIEDRICH NAUMANN FOUNDATION For Freedom, South Asia

Andhra Chamber of Commerce, in partnership with Friedrich Naumann Foundation for Freedom, South Asia, is organising a Programme on “Women Entrepreneurship – Best Practices from SAARC Countries”

on the 15th September 2021 from 10 a.m. to 2 p.m.

at Hotel Taj Coromandel, Chennai.

Its a Hybrid Event !

This is an exclusive programme for Women Entrepreneurs who want to scale up their businesses.

Chamber is creating a connected ecosystem for Women Entrepreneurs across SAARC Countries.

It is a hybrid event and no fee for participation but prior registration is mandatory.

Please register now through mail . WRITE TO – andhrachamber1@gmail.com

Download the Program Brochure Here

Hospital Management Information System (HMIS)

Indian Railways rolls out Hospital Management Information System (HMIS)

Indian Railways rolls out Hospital Management Information System (HMIS) over 156 Health facilities across Indian Railways !

Reading this PIB announcement today.

This announcement has triggered the interest of many and has seen conversations floating around the same .Seen “Appreciations” and also “WATCH OUT Govt Healthcare Initiatives” kind of statements.

Govts, when decide to take control of Healthcare delivery & make right investments, will throw real stiff competition to Pvt Healthcare. Country requires this balancing act in managing communities health.

Govts have not invested into creating Quality Healthcare Infra for decades and pandemic has shown the gaps to communities about the flaws in both Govt and Pvt Hcare Infra in the country.

All 3 As – pillars of Healthcare Delivery, came down crashing or crumbled.

Its hightime Govt Hcare institutions embrace digital healthcare by making right investments to improve Patient experience.

HIS or HIMS has been there in pvt healthcare for more than 2 decades and has not really taken off in a big way.Industry has seen very average utilization rates of around 30% or even less. Reasons for low utilization rates are too many but the key factor is lack of #Upskilling of Health Workers which is critical to make technology usage becomes a culture in any organisation.

Healthcare businesses have to focus in bringing alignment between People & Technologies to streamline their Processes, through massive people upskilling initiatives.

Railways investing into HMIS is a good move. What is needed is strengthening basic IT infra in all hospitals, providing hardware to people (which often doesn’t happen) and massive on the job training for the next 3-4 years to make this initiative very successful. Identifying Change Agents to lead and drive this Change internally is also very important.

User acceptance for digital health was also not there all these years and now users will accept hybrid forms of delivery in many businesses, healthcare being no exception.

With NDHM rollout on the cards, seamless integration of all these tech initiatives into NDHM’S platform become critical.

Railways have created their own HMIS platform.

Read the announcement below from PIB for more information.

Clinical Establishments Act

National Council for Clinical Establishments – Updated News

National Council for Clinical Establishments met recently and held discussions related to implementation of CEA and Minimum Standards.

Meeting was held to review the work done by the National Council so far, status of implementation of the
Act by the States/UTs and defining further Roadmap and consideration/decisions of specific agenda points.

Some of the key highlights of the meeting are captured below :

Hospitals

Inclusion of provision of mini oxygen plant/PSA plant and norms of oxygen availability as part of the minimum standards for hospitals for implementation under CE Act.

a. It was agreed that the primary focus should be to ensure availability of Oxygen as per requirement for all the services envisaged to be provided by the hospital. At least one third of total number of beds should be oxygen beds. Atleast 48 hours (preferably 72 hours) of oxygen of the total calculated oxygen requirement of the hospital should be available at any given time, as backup.

b. Oxygen requirement may be calculated as per the ME Division norms of oxygen cylinders based on Oxygen/ICU beds – NRBM/NIV/HFNC/Ventilator Bed capacity in the hospital for management of COVID-19, as mentioned in DO letter dated 21-6-2021 as at Annexure 1 c. Regarding the “establishment of Mini Oxygen Plants in hospitals and Clinical Establishments having more than 50 beds”, following action points were recommended:

i. Every new clinical establishment/hospital having more than 50 beds may be mandated to install Mini-Oxygen/PSA plants of appropriate capacity and specifications for their registration under Clinical Establishments Act, 2010.

ii. For the existing hospitals having more than 50 beds, a time period of 6 months (desirable) and 1 year (mandatory) may be given for compliance to the condition of installation of MiniOxygen/PSA plant.

iii. Accordingly it is recommended that this requirement may be included in the minimum standards for Hospitals and a notification in this regard may be considered to be issued by the MoHFW, as amendment to the Clinical Establishments (Central Govt ) Rules under the Clinical Establishments Act, 2010.

iv. The same advice as at points 3C (i), (ii) and (iii) above may be disseminated to the States/UT not covered by Clinical Establishments Act 2010 for enforcement under the respective State Clinical establishments Act or Disaster Management Act.

v. All small hospitals i.e 50 beds or less should also build infrastructure and add capacities to meet their oxygen requirements for the services envisaged to be provided by them, as per the type of the hospital.

vi. National Health Systems Resource Centre (NHSRC) is carrying out the revision of Indian Public Health Standards (IPHS) under NHM, accordingly they may clearly define oxygen requirements for various categories of hospitals ranging from 50 to 500 bedded in the revised IPHS guidelines.

Further NHSRC may define the capacity/specifications of equipment/ MiniOxygen/PSA plants to meet the oxygen requirement along with ensuring sustained Oxygen supply in Government Health facilities under NHM as a part of IPHS. They may consider defining the standards separately for difficult/remote/ inaccessible areas, if deemed necessary

Medical Testing Laboratories

Issues related to minimum standards for Medical Diagnostic Laboratories under the Clinical Establishments Act, 2010 (w.r.t suggestions received in respect of inclusion of PhD genetics and PhD scientists in minimum standards for Medical Diagnostic Laboratories)

The Council members were informed that the amended Gazette Notification in respect of Human resource requirements for Medical Diagnostic Laboratories has already been issued on 14-2-2020, which includes provision of MSc and MSc Phd with specified qualification and experience. They are permitted to conduct the tests, generate and sign test reports as authorized signatory for the specified types of tests of their domain area in the specified category of Laboratory, without recording any opinion or interpretation of the test results.

All such test reports generated must necessarily bear a disclaimer to the effect that the reports are strictly for the use of medical practitioners and are not medical diagnosis as such. The Gazette notification is available in public domain on the website of the Act. The participants endorsed the same.

The National Council approved the draft of Minimum Standards for Collection Centres, as finalized by the subcommittee and circulated with the agenda.

Online Health Portals :

The National Council considered the issue of regulation of online health services aggregator and related service providers under Clinical Establishments Act and their standards etc. It was noted that there is no specific provision for their regulation under the Act

a. The National Council endorsed the following recommendations of the “subcommittee for drafting standards for collection centre”

o Public to be made aware of such illegal online health aggregators

o Need to frame IT / Digital laws/rules to regulate them by the Ministry of Electronics and IT. Ministry of Health and Family may take it up with them and also consult Ministry of Law and Justice in this regard.

o The online Lab service aggregators and service providers should have a registration number and provide information regarding the lab where the samples are being sent for testing.

It was noted that a letter has been written by MoHFW to all States and UTs in this regard; however the respective States/UTs are required to take the necessary steps to regulate them.

It was recommended that all online service providers should have a linkage with the registered clinical establishments. Thus only a registered clinical establishment may be permitted to provide online services. MoHFW may issue necessary instructions to States /UTs in this regard. This may be enforced by the District Registering Authority at the district level and the State Council for clinical establishments at State level.

It was approved that a subcommittee under JS (Padmaja Singh), the Secretary of National Council may further examine the issue of regulation of online health aggregators in detail in consultation with stake holders and Law ministry, for taking appropriate action in the matter.

Patient Rights :

Inclusion of Additional Charter of patients’ rights in minimum standards.

The National Council for Clinical Establishments approved for inclusion of the following additional patient rights, as per NHRC Advisory, in the already approved list of patient rights.

Statutory Compliances

It was recommended to include AERB license as part of statutory requirements in the minimum standards as a pre-requisite for issuance of registration under CE Act, wherever applicable. Further it was approved to include AERB license in list of documents to be uploaded for grant of permanent registration to the clinical establishments, wherever applicable.

Full details of minutes covering list of Patient Rights and various other points discussed during the council meet, can be downloaded from here :

Stressed Hospital Asset

Stressed Hospital Asset available for Takeover

About Credimore :

Credimore is an organisation that facilitates monitoring, review of debt and in the event it is under stress, finds a resolution and worst case scenario recovery. Essentially addresses the complete lifecycle of debt.

Credimore is backed by professionals and domain experts with rich experience in identifying business stress and addressing them at an early stage, the proverbial “Golden Hour”, to ensure that it is dealt at an early stage.

As part of IBC processes, Credimore comes across multiple investment opportunities in potential businesses and assets that are in the stressed space and are available for takeover.

About the Stressed Asset :

One such opportunity is available in respect of a stressed hospital asset in Bengaluru.

As per the information shared in the public domain, the hospital is located at Marathahalli, Bengaluru with 217 beds facility in 1.70 lakh Sq. Ft. Land and Building.

The investors normally get benefited by reasonable and attractive prices for stressed assets which can be acquired after a thorough due diligence.

Any healthcare businesses looking for expansions and scale up, can reach out to Credimore, if interested for further details and information.

Businesses with growth plans, planning expansions through acquisition route also, can reach out to Credimore for any specific investment opportunities too in healthcare and other sectors as well.

Credimore will identify the business assets accordingly.

For further queries , please reach out to :

Contact :

Announcement from NABH

For Small Healthcare Organisations

NABH has issued a notification recently for Small Healthcare Organisations (SHCOs) which are Accredited, under Quality Management Systems Program.

Notification calls for Self Declaration cum Undertaking from already Accredited organisations / organisations under accreditation process, on the Bed Capacity declared to NABH for Accreditation purposes.

Content of the notification in a nutshell is shared here :

It has been brought to notice of NABH that many hospitals and nursing homes that have enrolled under the SHCO accreditation program of NABH, despite having sanctioned bed strength of more than 50. Notification has clarified that the bed strength of the organization will be considered only on the basis of the sanctioned beds mentioned in the statutory licenses obtained by the organization from the competent authorities. All the hospitals and nursing homes which are accredited by NABH or are in the process of getting accreditation are hereby informed to declare the bed strength and submit an undertaking signed by head of the organization to this effect to NABH secretariat within 45 days of issue of this notice.

The format for submission of the declaration is enclosed herewith and the same needs to be printed on the stamp paper of value of Rs 100/-.Further the signed declaration has to be uploaded on the ‘HCO document’ section on the respective portal account of SHCO. In case, the hospital fails to submit the declaration as mentioned above, NABH may be constrained to initiate adverse decision against the non-conforming
hospitals as per the policy of NABH.

Download the Notification from here :

NABH Certifies, Accredits organisations which fall under the category of Healthcare Organisations and Small Healthcare Organisations which are defined as below :

Healthcare Organisation :

Healthcare organization (HCO) that should be above 50 beds to fall under the definition of Healthcare Organisation as per NABH

Small Healthcare Organisations :
Hospitals and Nursing homes or day care centres with bed strength less or equal to 50 Sanctioned beds.

Exclusions to the above definition :
a) Polyclinic Diagnostic Centres
b) Super Speciality Centres

Certification / Accreditation Framework :

The Certification / Accreditation Framework for each segment differs as the criteria set by NABH varies accordingly.

Essence of the Recent Notification :

NABH’s definition of Beds in the case of SHCO is “Sanctioned Beds” meaning number of beds approved, sanctioned by the Regulator, State / Central Licensing Authorities.

Infact Hospitals apply for various empanelments with State Govts, Central Govt agencies, PSUs, Pvt Health Insurers, Corporates etc for business purposes. Sanctioned beds is the statutory norm and should be quoted with all agencies .

However , it was repeatedly discussed in various industry forums , market place conversations that beds shown for empanelment purposes & for accreditation purposes is most often different and not same as the sanctioned beds approved by the licensing authorities.

Hospitals were declaring less number of beds to NABH while applying for Accreditation which is technically not correct. Infact this was pointed out by various other healthcare organisations at the market place frequently.

Way forward :

NABH has announced a roadmap for such hospitals which are covered under Accreditation Program for implementation by SHCOs , as follows :

The hospitals which are not eligible to be covered under SHCO accreditation program due to sanctioned bed strength more than 50 should switch over and apply under hospital accreditation program. Considering the fact that there could be a break in accreditation while switching over to hospital program, NABH has decided to give a transition period of 18
months from the issue date of this notification.

The hospitals are encouraged to implement NABH 5th edition of hospital standards with in
the given transition period and apply for accreditation under hospital program.

Further, during the transition period hospitals shall also be required to pay the shortfall of the
applicable annual accreditation fee based on the sanctioned bed strength of the hospital.

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