Post Graduate Certificate Programme in Digital Health

Certified Digital Health Professional (CDHP) course

The CDHP™ is jointly offered by the leading institutions across Digital Health and Management – Digital Health Academy and Indian Institute of Management (IIM) Raipur

Certified Digital Health Professional’ (CDHP) course blending the fields of Health, Technology and Management, will equip clinicians, paramedics, healthcare professionals, and managers to understand the Digital Health domain and the deployment of digital health tools.

Ideated in 2020 by Digital Health Academy, CDHP is the result of two years of research, brainstorming, and extensive consultation with around 60 global leaders across the healthcare domain working in hospitals, the pharmaceutical industry. research & development, med-tech, information technology, regulators, and policy makers across the countries. The course is a unique blend of the world’s best faculty and use cases in digital health. This Course jointly offered by Digital Health Academy and Indian Institute of Management, Raipur.

The year-long course will be completely online specifically designed for healthcare and management professionals. The CDHP course has three levels; Basic, Advanced and Professional. This course aims to provide knowledge on theoretical, technological, management and application aspects of digital health acorss the continuum of care.


The course certificate will be awarded by IIM Raipur and Digital Health Academy

Source: https://health.economictimes.indiatimes.com/news/health-it/treating-a-patient-with-pills-alone-is-over-it-is-time-for-digital-health/96474796

Admission Open – ISO 13485:2016 – Lead Auditor Training

ISO 13485:2016 – Lead Auditor Training Program (Medical Device Quality Management Systems )

Indian Biomedical Skill Consortium (IBSC) is conducting Lead Auditor Training Program on ISO 13485:2016 standard.

Program Details are given below:

Program: ISO 13485:2016 – Lead Auditor Training (Medical Device Quality Management Systems )

Certificate: CQI & IRCA Certified Course

Duration: 5 Days (23rd – 27th January 2023)

Last date for Registration : 12th January 2023

Location: Kalam Convention Center, AMTZ Campus, Vizag

Program Details: https://ibsc-amtz.in/coursedetails/23

For quotation send email to n.nareshkumar@ibsc_amtz.in
➖➖➖➖➖➖➖➖➖➖
For more information, please contact
Mr. Nitturi Naresh Kumar
Mobile: 8897330990
WhatsApp Link: https://wa.me/918897330990
n.nareshkumar@ibsc-amtz.in

Source: https://ibsc-amtz.in/

CDSCO Notification on Resellers

Registration by Medical Device Distributors, Stockists, Exhibitors or Resellers made a must under Medical Device Regulations

Ministry of Health and Family Welfare (MoHFW) has asked Distributors, traders and resellers of medical devices to register in an attempt to expand the ambit of regulating the medical devices industry in the country.

In a notification dated September 30 2022, the Union Ministry of Health and Family Welfare said anyone wanting to sell, stock, exhibit or offer for sale or distribute a medical device, including in-vitro diagnostic medical device, will need to obtain a Certificate of Registration. These rules may be called the Medical Devices (Fifth Amendment) Rules, 2022.

These rules shall come into force on the date of their publication in the Official Gazette.

Key points from the Notification released :

In the said rules, after rule 87, the following rules shall be inserted, namely:—

“87A. Registration certificate to sell, stock, exhibit or offer for sale or distribute a medical device including in vitro diagnostic medical device.—

(1) The State Licencing Authority shall appoint Licensing Authorities for the purpose of issuing registration certificate under this Part for such areas as may be specified.

(2) Any person who intends to sell, stock, exhibit or offer for sale or distribute a  medical device including in vitro diagnostic medical device, shall make an application in Form MD-41 to the State Licensing Authority for grant of registration certificate to sell, stock, exhibit or offer for sale or distribution.

(3) The application made under sub-rule (2) shall be accompanied with

  • a fees specified in Second Schedule;
  • self certificate of compliance with respect to Good Distribution Compliance;
  • details of the applicant or firm including its constitution, along with identification proof, such as, Aadhar card or PAN card;
  • documentary evidence in respect of ownership or occupancy on rental of the premises;
  • details of competent technical staff, under whose direction and supervision the sales activity of medical device shall be undertaken, who shall possess the following educational qualification and experience, namely:—
    • hold a degree from a recognized University/Institution; or
    • is a registered pharmacist; or
    • has passed intermediate examination or its equivalent examination from a recognised Board with one-year experience in dealing with sale of medical devices;
  • brief description on other activities carried out by applicant, namely, storage of drugs, medical items, food products, stationeries, etc., or any other activities carried out by the applicant in the said premises; and
  • an undertaking to the effect that the storage requirements to sell, stock, exhibit or offer for sale or distribute a medical device will be complied with.

(4) The State Licensing Authority shall, after scrutiny of documents and on being satisfied that the requirements of these rules have been complied with, grant a registration certificate in Form MD42, or if not satisfied, reject the application for reasons to be recorded in writing, within ten days from the date the application is made under sub-rule (2).

(5) If the application for grant of registration certificate to sell, stock, exhibit or offer for sale or distribute a medical device is rejected under sub-rule (4), the aggrieved person may prefer an appeal before the State Government within forty-five days from the date of receipt of such rejection, which may, after such enquiry and after giving an opportunity of being heard to the appellant, dispose it within a period of sixty days from the date of receipt of such appeal.

87B. Conditions of registration certificate to sell, stock, exhibit or offer for sale or distribute a medical device including in vitro diagnostic medical device.—

(1)The registration certificate granted under rule 87A shall be displayed at a prominent place in the premises visible to the public.

(2) The registration certificate holder shall provide adequate space and proper storage condition for storage of the medical devices.

(3) The registration certificate holder shall maintain requisite temperature and lighting as per requirements of such medical devices.

(4) The medical devices shall be purchased only from importer or licensed manufacturer or registered or licensed entity.

(5) Separate records, in the form of invoice or register or electronic details including software of purchases and sales of medical devices showing the names and quantities of such medical devices, names and addresses of the manufacturers or importers, batch number or lot number and expiry date (if applicable) shall be maintained. 

(6) The records referred to in sub-rule (5) shall be open to inspection by a Medical Device Officer appointed under the sub-rule (2) of rule 18, who may, if necessary, make enquiries about purchases and sale of the medical devices and may also take samples for testing.

(7) All registers and records mentioned under these rules, shall be preserved for a period of not less than two years from the last entry, therein.

(8) The registration certificate holder shall maintain an inspection book in Form MD-43 to enable the Medical Devices Officer to record his observations and defects noticed.

87C. Validity of registration certificate.— (1)A registration certificate issued in Form MD-42, shall remain valid in perpetuity, subject to payment of registration certificate retention fee as specified in the Second Schedule, before completion of the period of five years from the date of its issue, unless, it is suspended or cancelled by State Licensing Authority:

Provided that, if the registration certificate holder fails to pay the required registration certificate retention fee on or before due date, the registration certificate holder shall, in addition to the registration certificate retention fee, be liable to pay a late fee calculated at the rate of two per cent. of the registration certificate retention fee for every month or part thereof within six months:

Provided further that in the event of non-payment of such fee within the period referred to in the first proviso, the registration certificate shall be deemed to have been cancelled.

87D. Suspension and cancellation of Registration Certificate.— (1) Where the registration certificate holder contravenes any provision of the Act or these rules, the State Licensing Authority, shall, after giving the registration certificate holder an opportunity to show cause as to why such an order should not be passed, by an order and for reasons to be recorded in writing, suspend it for such period as it considers necessary either wholly or in respect of any of the medical device or, as the case may be, cancel the registration certificate.

(2) A registration certificate holder whose registration certificate has been suspended or cancelled by the State Licensing Authority under sub-rule (1), may within forty-five days of the receipt of a copy of the order by such authority, prefer an appeal to the State Government and the State Government, shall after giving the registration holder an opportunity of being heard, confirm, reverse or modify such order, with reasons to be recorded in writing.”.

Notification also contains other information like application format (MD 41), MD 42, fee details etc .

Download the notification here

WAD 2022 Event Update from CCC

World Accreditation Day Conference – Post Event Update

World Accreditation Day Conference 2022 – Post Event Update

WAD 2022 Conference jointly organised by International Accreditation Services (IAS), USA; Bureau of Indian Standards and Consultants Consortium of Chennai ended on June 10th 2022 with a positive a note.

Two days conference held on June 9th and 10th had eminent speakers from India and abroad , from various sectors , sharing rich insights about Standards, Certifications, Accreditations, Inspections & Regulations related to Sustainability and Environment across the globe.

Two days of intense learning sessions came to an end on June 10th.

Conference had 324 delegates registering for multiple sessions across two days and the feedback received from them is very encouraging.

The conference is supported by many Trade and Industry Platforms as listed below :

Sharing few pictures of the event for reference :

Session Videos are shared here for industry and stakeholders benefit. Please check the links below

INAUGURAL SESSION :
Theme – Sustainability in Economic Growth and the Environment

TECHNICAL SESSION 1:
Theme – Sustainable Standards for a Safer World

TECHNICAL SESSION 2 :
Theme – ESG Rating for Sustainability Initiatives

TECHNICAL SESSION 3 :
Theme – Sustainability Initiatives in Food Sector

TECHNICAL SESSION 4 :
Theme – Sustainable Healthcare Initiatives

TECHNICAL SESSION 5 :
Theme – Incorporating Sustainability in Educational Institutions

PHDCCI Conference

Interactive Video Conference on Preparing for Licensing Norms for Class A and Class B Medical Devices (w.r.t 1st October 2022)

Chandigarh Chapter, PHDCCI is organizing 4th in the MDR-17 Series, Interactive Video Conference on Preparing for Licensing Norms for Class A and Class B Medical Devices (w.r.t 1st October 2022) as per the following schedule:

Day & Date: Friday, 24 June 2022
Time: 2:30 pm to 5:00 pm
Platform: Zoom

Session Highlights
• Regulation of medical devices and recent amendments
• Steps to Licensing for Class A & Class B Devices/Products
• QMS requirements for Medical Devices
• Demonstrating Product Compliance as per MDR-17
• Challenges faced by Medical Devices Manufacturers

Key Speakers
• Dr. Ravi Kant Sharma, Deputy Drugs Controller, Ministry of Health & Family Welfare Government of India, New Delhi
• Mr. M G Sathyendra, Consultant & Trainer – Global Certifications
• Mr. Hemant Bhardwaj, Founder & President, Global Medical Devices Experts Foundation
• Mr. P.K.Minocha, Director, Meril Life Sciences Pvt. Ltd., Chala Gujarat
• Dr. Sanjiiiv Rehlan, Chief Executive Officer, Shalex Overseas & Member, Association of Indian Medical Device Industry (AIMED), New Delhi
• Ms. Rama Venugopal, President, Consultants Consortium of Chennai & Executive Director, Value Added Corporate Services (P) Ltd., Chennai

Please register in advance by clicking the link:
https://us02web.zoom.us/meeting/register/tZIpcuGhqT0oE9MghceheO3F_QWzn45B7CTc

You tube link of the session is also appended.
https://youtu.be/1AHq92C_F2A

You may send your questions to rimneet.kaur@phdcci.in prior to the session.
The relevant questions will be answered during the programme.

For any query, you may contact:
Ms. Rimneet Kaur, Resident Director, PHD Chamber
Mob:+91 81460 02297 | Email: rimneet.kaur@phdcci.in

Mr. Avneet Singh, Sr. Resident Officer, PHD Chamber
Mob:+91 8283848012 | Email: avneet.singh@phdcci.in

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

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.

World Accreditation Day 2021 Celebrations

Word Accreditation Day Celebrations 2021 – Organised by Consultants Consortium of Chennai

World Accreditation Day 2021

Theme – Accreditation: Supporting the Implementation of the Sustainable Development Goals (SDGs)

09 June 2021 marks World Accreditation Day (#WAD2021), a global initiative established by IAF and ILAC to promote the value of accreditation. This year’s theme is Accreditation: Supporting the Implementation of the Sustainable Development Goals (SDGs). 

The SDGs are at the core of the United Nations’ 2030 Agenda for Sustainable Development, a broad and ambitious plan of action with the overarching objective of leaving no one behind. Accreditation, in collaboration with other quality infrastructure institutions, provides the technical foundations that are critical to the functioning of developed and developing societies. It enables industrial development, trade competitiveness in global markets, efficient use of natural and human resources, food safety, and health and environmental protection.

IAF and ILAC have published a joint WAD 2021 statement by the IAF and ILAC Chairs, a brochure and a poster:

In addition, three videos with the themes of People, Planet and Prosperity will be released on the IAF-ILAC Youtube channel in mid-May. These three pillars group the SDGs according to common goals and are reflective of publications from UNIDOOECD and UNDP.

The Public Sector Assurance and Business Benefits websites, which contain case studies, research and supporting materials demonstrating the benefits and value of accreditation, also now feature an option for searching by SDG. 

While the COVID-19 pandemic may again disrupt physical WAD events, we encourage everyone to celebrate with us online using the hashtag #WAD2021 and to contact your local accreditation body for further details on local media and online seminars and programs they may be organising.

Source : https://www.iaf.nu/articles/World_Accreditation_Day_2021/685

About Consultants Consortium of Chennai – CCC :

Consultants Consortium of Chennai (CCC) is an Association of Management Systems Consultants, registered under the Tamil nadu Societies Registration Act, 1975.

The Key Objective of CCC is to work in alignment with the National Quality Mission launched by the Government of India by educating the industry about the role and importance of Standards, Certifications and Regulations in the country as well as in the global markets.

CCC strives to encourage Responsible Consulting through Members of its Association and focus is to Standardize Consulting Practices in alignment with changing market and industry needs in a dynamic manner.

The focus is also to identify areas and industries in which the consultants in the profession of Management Systems Consulting can contribute to the betterment of the society and the country and to promote Management Systems Consulting in such areas or industries.

One of the core objectives is to collaborate with various Industry platforms, Trade Associations, Chambers of Commerce, Management Associations, Apex Bodies of Government or Quasi Government Organization to contribute to the betterment of the industry initiatives, which will in turn contribute to the betterment of the society.

Webinar Series organised by CCC :

CCC has organised #WAD2020 successfully. Same initiative is planned by CCC for 2021 as well.
CCC has tentatively scheduled a week long sessions with following topics :

Registrations :

Entry is free for all Management Systems Consultants, Technical Experts, Industry Experts, Professionals, Industry Members, Academia , Students, Members of Trade & Industry Associations

Program Dates are listed above.

Registration Link :

Prior Regn is a MUST for Participation. All regd participants will get email confirmations 2 days before the commencement of the sessions.

For queries on Regns, email can be sent to :

Ms Rama Venugopal – contact@ccc-consultants.org – +919840870532
Mr D Srikanthan – secretariat@ccc-consultants.org – +919003056539

Do visit CCC Website for regular updates – http://ccc-consultants.org/wad-2021-celebrations/

Medical Testing Labs

Regulations or Accreditations ??? – beginning of a new conundrum

Medical Labs are undoubtedly an important part of the health ecosystem in any country but in India, like many other sectors related to health and safety, they have remained largely unregulated and therefore lacking assurance of quality and reliability.

The Clinical Establishments Act, 2010 intended to fill this gap but unfortunately only 11 states and almost all union territories have adopted the Act till now and from all accounts none has enforced the minimum standards prescribed under it. Therefore, there is not even data on how many medical labs are operating in the country much less any measure of their quality. The role of medical labs came into sharper focus as covid pandemic set in and India scrambled to develop covid testing facilities.The question begs an answer not only in relation to covid testing but for the larger issue of assuring quality of medical labs in general in the country.

Read the informative post by Mr Anil Jauhri, International Conformity Assessment Expert about Medical Labs and whether they need Regulations or Accreditations in the country .

Source : Healthcare Quality News Letter from QAI – http://www.qai.org.in/