One Day National Conference on Standards, Certifications & Regulations – Andhra Chamber of Commerce
Andhra Chamber of Commerce, a 95 year old Chamber of commerce with headquarters in Chennai, is organising a One day National Conference on Standards , Certifications and Regulations covering following sectors :
– Agri and Food Products – Gems and Jewellery – Leather and Footwear
Program covers sessions on Global Market Opportunities for Businesses and various applicable Domestic and International Standards, Certifications and Regulations the businesses have to comply with, while exporting products.
Program Details are given below : Date : February 23, 2024 – Friday Time : 10 am to 5 30 pm Location : Hotel Ramada Plaza, Guindy, Chennai
Who Should Attend ?
Food & Agri Product Companies, Producer Groups : This is an opportunity for Farmers, FPOs, Producer groups, such as cooperatives, consortiums, and producer organizations, Manufacturers, Exports, Traders, Distributors, Retailers, Resellers, Startups, Innovators, Ecommerce companies, Testing labs, other key stakeholders etc from Food and Agri Products space to understand more about Export Opportunities and related Regulations, Standards , Certifications, Product Testing norms that businesses have to meet to Go Global.
Registration :
There is NO FEE. Program is open for industry members, other stakeholders from respective sectors, but prior registration is a must.
It’s an initiative from Chamber to sensitise industry on an ongoing basis about International Trade Opportunities and market access norms that businesses have to comply with
For more details, please contact :
Mr Barnabas Immanuel Program Co-ordinator Phone : 24315277/78 Mob:7305063885 Email : andhrachamber1@gmail.com acc@andhrachamber.com
HOSPEX Healthcare Expo cum Conferences 2023 – SEP 15-17,2023 at Zamra International Convention Centre, Kochi, Kerala
The “First, Best, and Only Hospital Expo in Kerala” for all your Medical Equipments and Hospital needs.
Experience the Next Generation of Healthcare at HOSPEX Healthcare Expo in Kerala! Join us as we bring together leading manufacturers and suppliers from the medical industry to showcase cutting-edge medical equipment and innovations. From state-of-the-art imaging technology to advanced surgical instruments, explore the latest advancements that are shaping the future of healthcare.
2nd Edition of HOSPEX Healthcare Expo cum Conferences will be held at Kochi, Kerala from Sep 15th – 17th 2023. This is Kerala’s first B2B Medical Expo which will take place at Zamra International Convention and Exhibition Center, Kochi, Kerala.
HOSPEX 2023 Expo is the platform to showcase Technology, Products & Innovations to the healthcare fraternity.
Expo cum Conference Theme this year is on :
Future of Healthcare – Device | Digital | Diagnostics
Don’t miss this exclusive opportunity to witness the forefront of medical technology under one roof at the HOSPEX Healthcare Expo.
HOSPEX Expo has a projected walk-in of 10000+ professionals and entrepreneurs from all over South India including doctors, hospital owners, managers, supply & purchase staff, distributors that are all from the medical industry.
HOSPEX is the Convergence platform where Makers (Medical Device Manufacturers) , Users (Healthcare Establishments) and Innovators (MedTech, HealthTech, Digital Health Innovators, FinTech, Insuretech, CyberTech etc) and Governments , Policy Makers join the connected conversations to strengthen and improve the Healthcare Ecosystem in the country.
The core focus of HOSPEX Healthcare Expo 2023 is medical knowledge dissemination thereby hosts multitude of conferences focused on the futuristic trends in the medical industry. These conferences provide attendees with the opportunity to learn about new products and technologies, network with other professionals in the field, and stay up-to-date on the recent and futuristic developments in the industry.
SMART Hospitals Conference
Date : Sep 16, 2023
Time : 10 00 am to 6 00 pm
Fee : Rs 500 per delegate
SMART Hospitals Conference focus is to enable Micro and Small Hospitals to Go Digital, use various HealthTech and MedTech Solutions – be it for Clinical Decision Support Solutions, Tech Solutions to help Hospitals to streamline their day to day practices, Tech solutions to improve productivity of healthcare workforce, Technologies that facilitate Quality and Safe Patient Care.
Conference will connect SMART Technologies, Solutions that are needed in healthcare settings as Future of Healthcare will be driven by Practitioners , Healthcare Settings using SMART Devices, Diagnostics and Digital Solutions.
Conference Outline :
SMART Medical Technologies help Practitioners to improve service standards
SMART Medical Device for Safe Patient care in Clinical Settings , Home Healthcare Setting
Testing and Certification of SMART Medical Devices – Global Regulations and Certification Requirements
Empowering Practitioners : Virtual Cardiac Care Diagnostic Solutions
Telehealth and Telemedicine – NMC Regulations & Clinical Establishments
SMART Prescription for Prescribers – EHR Solution
SMART Technologies to enable Small Hospitals – Technology Session
SMART HealthTech Ecosystem
Digital Health Apps for Enhancing Patient Satisfaction, Loyalty and Referrals
Digital Ecosystems: Future of Healthcare – The Value for All: Patients, Healthcare organisations and Innovators, Startups
Smart Healthy Aging Tech Solutions
Target Audience :
Medical Professionals, Healthcare Professionals from Hospitals and other Healthcare organisations, HealthTech, MedTech Professionals , Startups, Innovators, Incubation Hubs, Medical Device Industry Representatives, Digital Health Teams, Quality Professionals, Regulatory Affairs Professionals and other stakeholders like Insurers, Governments, Regulators, Corporate Health & Wellness Teams, Corporate Medical Centers, Home Healthcare Service Providers etc
HOSPEX PURCHASE MANAGERS WORKSHOP – FOR BIOMEDICAL TEAMS, PROCUREMENTS TEAMS IN HOSPITALS AND OTHER HEALTHCARE SETTINGS
Venue: Zamra Convention Centre, Kochi, Kerala
Date : September 15, 2023
Time : 2 30 pm – 5 30 pm
Fee – Rs 250 + GST
Target Audience :
Healthcare Professionals Who are incharge of Procurement Practices in Hospitals and other Healthcare Settings
Medical Professionals, Promoters, Management Teams, Administrators, Purchase Teams, Biomedical Engineers, Finance Teams, Quality Teams , other functional heads who are interested in understanding more about Quality and Safety related Regulations of Hospital Supply Chain and Vendors .
Workshop shall cover following items that Hospitals Procure with special reference to:
– Biomedical Equipments
– Consumables and Disposables
– Standalone MedTech or Healthtech Software that is used for clinical decision support purpose
Program Objective :
Since Medical Devices, Health Technologies are part of the Value Chain of Hospital Supplies, its imperative for Procurement Teams, Purchase Managers, Finance Teams, Promoters , Quality Teams to learn more about Regulations and Compliances related to their Supply Chain , Value Chain of Hospitals (Suppliers and Vendors)
Hence HOSPEX has designed an Awareness Session covering the following topics for Hospital Teams who are incharge of Procurement :
Understanding Medical Device Regulations- Laws of the Land
Medical Device Regulations – Role of Bureau of Indian Standards
Foreign Regulations , Quality Specification – How its listed in other Key Global Regulations
Claims of Voluntary Certifications – How Authentic these claims are ?
Materiovigilance Program of India – Regulatory Requirement
Interactive Video Conference on Understanding ISO 13485 Certification for Medical Devices
Chandigarh Chapter, PHDCCI is organizing 5th in the MDR-17 Series| Interactive Video Conference on Understanding ISO 13485 Certification for Medical Devices as per the following schedule:
Day & Date: Friday, 15 July 2022 Time: 2:30 pm to 5:00 pm Platform: Zoom
Session Highlights
• 7 Basic Quality Management Principles • Overview of the Certification process and • Importance of 13485 Certification from Compliance perspective
Key Speakers
• Mr. Mahadevan. J, VP & Business Segment Head – Medical, DQS India- Deutsch Quality Systems (India) Private Limited, Kodihalli, Bengaluru • Mr. M G Sathyendra, Consultant & Trainer – Global Certifications, Qmart Global, Yeshwantpur, Bengaluru • Mr. P.K.Minocha, Director, Meril Life Sciences Pvt. Ltd., Chala Gujarat • Mr. Rajiv Nath, Forum Coordinator, Association of Indian Medical Device Industry (AIMED), New Delhi • Col. Rajiv Bhargava(Retd.), Associate Director, Indian School of Business, Mohali
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 :
Inaugural
Speakers introduction
Speakers introduction
Dr R Velraj & CCC’s VP Mr Ramkumar Sivaraman
Inaugural Session
Inaugural SessionDr R Velraj’s Keynote AddressBIS TeamDR R Velraj, VC, Anna University & Shri USP Yadav , DDG – BIS , Southern RegionDr Deepak Samuel V, CMR – NCSCM, SpeakerMr Nambi , GC Member – CCCDr M Sasikala NHHID – Anna UniversityMr Ashish Dev Lead Auditor & Tutor- COTECNA IndiaMe U S P Yadav, Scientist F and Deputy Director General , ( Southern Region) – BISOffsite DelegatesMr Premkumar Jayvin Md/ Principal Consultant , Jayvin Management Systems and SolutionsMr K Vijayaveeran Scientist D & Joint Director Bureau of Indian StandardsDr Ghadevaru Sarathchandra, Professor and Head TANUVAS & Representative of NABLDr R Velraj & Dr Ghadevaru SarathchandraDr K Sankaran , Dr M Sasikala – NHHID HubMr Anil Jauhri, Ex CEO – NABCB & SpeakerMr Ramanathan Ganesan DQS India , SpeakerDr Jagannath Patil Advisor, NAAC India & SpeakerMs Nisha Rani Legal & EIA Expert , SpeakerMs B Sandhya, Scientist G – Head – Certification, KIHT, SpeakerMr Vivek Kulkarni, Laundry Expert , SpeakerMr R Deswal, President , AOIL & SpeakerDr Harinder Singh Oberoi Advisor ( Quality Assurance ) – FSSAIMr Karthik S Easwar, Head, Quality and Regulatory Affairs, IAS, USAMr VIshnu P. Sudarsan Partner, J Sagar AssociatesDr Nisha Kohli, Founder & CEO CorpStage – Sustainability Platform, SpeakerDr Aparna Dhawan Executive Director, TIC Council IndiaMr Amit Thusu, Sr. Director – Climate Actions, Global Carbon Council, SpeakerMs Jyotsna Belliappa, Founder and Director – Bluesky Sustainable Business, SpeakerMr Prosenjit Mitra, Dy. General Manager, TUV SUD South Asia, SpeakerMr Sandeep Bhargava CEO – Onecert International Nominee – ACBI, SpeakerMr Karthi Thiyagarajan, GC Member – CCCMr Thiruvengadam, GC Member – CCCMr D Srikanthan, Secretary – CCCGC Members – CCCCCC TeamDelegates – OffsiteCCC TeamCCC TeamConference Venue – National Centre for Sustainability and Coastal Management
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
Announcements from NABH – Fee Remittance Norms & Communication Matrix to be followed by all Applicant / Certified / Accredited Healthcare Organizations
Announcement 1 – Fee Remittance Notification
Kind Attention : All applicant / Accredited / Certified Health Care Organisations under all programs of NABH
In continuation to the previous notice of NABH related to fee payments issued on February 16, 2021, many Healthcare Organisations associated with NABH, are still making direct payment to Quality Council of India – NABH. NABH is facing d i f f i cu l t y in reconciling the amounts received directly as the details of payment are also not updated by the respective HCOs in their online portal.
To avoid unnecessary wastage of time and manpower in tracking the payments, NABH advises its stakeholders to make payments only through the online portal using the Payment Gateway so that the payments are appropriately tracked for convenience of all the parties.
In order to facilitate the Healthcare Organisations to reconcile the fee payment status, NABH is requesting all the HCOs to follow the below steps with immediate effect:
The HCOs a r e advised to login into their HCO account on the NABH portal for making payments through payment gateway via credit card/debit card/net banking.
HCOs are advised to refrain from depositing cash/cheque/DD directly into any account of Quality Council of India.
In case the HCO has no other option but Bank Transfer (NEFT/RTGS), it shall be responsibility of the HCO to update the transaction details like Unique Transaction Reference (UTR) Number, Date of Transaction, Transaction Amount, etc on the NABH Portal under the Make Payment category and inform NABH that the Payment was done and get the receipts generated for the payments made.
The HCOs are also requested to ensure that the payment details with respect to fee payments of current and previous accreditation cycles have been updated on the NABH portal account of the HCO, if not done earlier.
QCI-NABH plans to stop direct payments into its accounts done through DD/Cheque/Cash Deposit/Offline Bank Transfer (NEFT/RTGS) by March 31, 2022 and is seeking the cooperation from HCOs in this regards.
Announcement 2 – Communication Matrix Released for the benefit of all Applicant / Certified / Accredited HCOs
NABH has earlier issued NABH communication matrix – NABH/Notification/Communication/2020/2049 dated 25th September 2020
All the applicant and accredited/ certified HCOs that are listed in the NABH portal have the provisions for making communications with the officials of NABH through “REMARKS COLUMN”. All HCOs are requested to utilise “REMARKS” for communicating/ raising queries regarding status of their applications for accreditation/ certification to ensure transparency as well as for records.
HCOs are also requested to refrain themselves from communicating through emails or telephonically. It is practically not possible to reply to each mail or phone call individually. Moreover, neither your communication nor reply from NABH is captured for the case record purpose.
In case, the queries of the HCOs submitted through remarks on the portal are not replied within three working days, emails to Program Heads may be sent, along with contents of email copied at on-line portal remark column. The list of all programs of NABH and the responsible Program Head with contact details are listed in the notification released by NABH.
Fresh Notification – Voluntary Registration&Labelling Normsfrom 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”.
Medical Laboratories & the need to create a dedicated Laboratory Director Post / Designation to satisfy QMS requirement
Isn’t this becoming a HR issue
A Laboratory Professional from a client organization reached out to us seeking clarification on Lab Director’s role in Accreditation process. She was asked by the Management to redesignate Lab Director as Lab head in Accreditation documents and she wanted to know if its ok to do so as Accreditation norm is asking for Lab Director designation.
This has triggered an internal discussion at office and we were debating about the need to create / insist on Lab Director’s designation / role in labs seeking accreditation.
Medical Labs were obtaining National / International Certifications, Accreditations all these years and each program has its own spec. However, the global trend in the last few years has shifted towards introducing Minimum Standards for Medical Labs and many countries have rolled out the program. India too has rolled out the Minimum Stds for Labs as Regulatory spec under Clinical Establishments (Registration and Regulation) Act, 2010.
Let’s take the case of a Lab appointing a Lab Director as an accreditation norm and see what is listed out by various National , International Stds for this requirement.
We have the following popular programs for Medical Labs running in our country :
Minimum Standards mandated under CEA. Both NABL, QAI offer Certification programs under this scheme in the country.
ISO 9001:2015 – Quality Management Systems Certification Program
Med Labs Accreditation Programs offered by NABL, CAP and QAI
Minimum Standards has mandated the Minimum qualification of Technical Head of Laboratory or Specialist or Authorized Signatories. Clearly defined spec on who should act as Technical head is mentioned. So any Certification program offered by NABL, QAI or any other body has to have the same spec in their Certification, Accreditation criteria as compliance to Minimum Standards is a Regulatory requirement.
ISO 9001:2015 Standard Clause 7 Support talks in general about Personnel competency, training needs etc. No other specification is listed as it’s a generic QMS Standard applicable for all businesses.
NABH Essential Standards for Medical Laboratories program talks about Personnel and its clearly mentioned about the Responsibility of Quality Manager & Technical Manager. But with respect to overall responsibility of the Laboratory Head, NABH Essential Standard for Medical Laboratories hasn’t mentioned anything much. So overall responsibility of Lab Head s not clear enough under this program.
QAI’s Recognition for Medical Laboratory Program, in Human Resources section – MBBS Doctor or MSc Pathology/Medical Microbiology/Medical Biochemistry are recognized qualification for Authorized Signatory. But there is no evidence of defining the overall responsibility of the laboratory head and the same isn’t clear in the QAI Recognition of Medical Laboratory Program either.
NABL’s Med Lab Accreditation Program mentions that Laboratory Director/ Head of Laboratory/ Technical Head (howsoever named), shall have the overall responsibility of Operations of the laboratory. Hence Lab Director’s Designation / Role is not mandatory. This is thee specific criteria document on NABL which is NABL 112. But the Standard for this program is ISO 15189:2012 which talks about the need to designate Laboratory Director.
CAP’s Laboratory Accreditation Program has a mandatory specification for Lab Director’s Designation and Role.
When 80-90% of the Labs in the country belong to Small labs category, can all qualify for Certifications, Accreditations. An ideal case is for Small labs to opt for Minimum Standards as 1st step towards the Quality journey before migrating to Certifications, Accreditations Programs. Compliance to Min Stds is also mandatory as it’s a Regulatory requirement.
My Thoughts as a Lab QMS Consultant :
I’m going back to the question asked by the Lab Professional whether its mandatory to have Lab Director Role and Designation in the Accredited Lab.
As a Consultant in healthcare industry, I would say it’s a debatable topic. The requirement depends on the National, International Standards followed by the Med Labs.
I have listed out the personnel spec given by each Standard for Med Labs. Lab Director’s Designation is a hierarchy in the organogram and can’t be maintained by all Labs. Labs can specify their own designations as listed in the NABL 112 Criteria OR criteria.
