Category: Calibration Centers

HOSPEX Healthcare Expo 2023

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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.

For more information about Expo, visit – https://hospex.in/

All Conference details are available at – https://hospex.in/hospex-2023-conference/

Contact :

T S Soumya, Hospex
+91 9080078447
Email – reach@hospex.in

Hospex Conferences

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

Program Brochure
Registration

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
  • Post Market Surveillance of Medical Devices
  • Biomedical Engineers Skill Certification Program, Scheme Details, Benefits 
Program Brochure
Registration

Contact Details :

For more information about Conference, visit – https://hospex.in/hospex-2023-conference/

For more information about Expo, visit – https://hospex.in/

For support in registration, reach out to :

Ms Soumya – 9080078447 

Email – reach@hospex.in

News Letter

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Materiovigilance Program of India (MvPI) News Letter

Indian Pharmacopoeia Commission has released its News Letter – Materiovigilance Program of India Volume 5 – Issue 1 recently.

Sharing the same for information

Click here to read the News Letter

Cybersecurity in Medical Devices

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FDA requires medical devices be secured against cyberattacks

Medical devices are increasingly connected to the Internet, hospital networks, and other medical devices to provide features that improve health care and increase the ability of health care providers to treat patients. These same features also increase potential cybersecurity risks. Medical devices, like other computer systems, can be vulnerable to security breaches, potentially impacting the safety and effectiveness of the device.

Under FDA guidance issued this week, all new medical device applicants must now submit a plan on how to “monitor, identify, and address” cybersecurity issues, as well as create a process that provides “reasonable assurance” that the device in question is protected.

Applicants will also need to make security updates and patches available on a regular schedule and in critical situations, and provide the FDA with “a software bill of materials,” including any open-source or other software their devices use.

As part of the new law, the FDA must also update its medical device cybersecurity guidance at least every two years.

Click here to read more

Source: https://www.fda.gov/medical-devices/digital-health-center-excellence/cybersecurity

One Person Company (OPC)

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NABL accepts the “One Person Company (OPC)” as a legal entity of CAB

NABL accepts the “One Person Company (OPC)” as a legal entity of CAB under the Companies Act 2013.

An OPC has features of a Company along with the benefits of a Sole Proprietorship.

An OPC can have just one single member and one Director. The Director and member can also be the same person. OPC of sole-proprietor and company form of business has been provided with concessional /relaxed requirements under the Companies Act, 2013.

The accredited CABS which are under Proprietorship are given a transition period till 31.12.2023 to align with any one of the legal entities specified in the Notification

click here to read the Notification

Source: https://nabl-india.org/

WORKSHOP ON INDIAN MEDICAL DEVICE REGULATIONS

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Workshop on Indian Medical Device Rules 2017

Indian Medical Device Regulations workshop ensures the safety and effectiveness of medical devices and gives overview of the efficient and safe manufacture of medical devices.

LEARNING OBJECTIVE

  • Candidate will get the knowledge on new legal requirements of the Indian Medical Device Regulations (IMDR).
  • Overview of the safe and efficient manufacture of medical devices in accordance with the Indian Medical Device Regulations (MDR).
  • To understand the responsibilities and obligations as a manufacturer, importers, and distributers of medical devices

COURSE AGENDA

  • Contents and Fundamentals of the Indian Medical Device Regulation (IMDR)
  • Classification of Medical Devices
  • Basic Requirements
  • Content Requirements for Technical Documentation
  • Validity of Conformity Assessment and Certification, Transition Periods
  • Requirements for Manufacturers, Importers, Distributors and Service Partners

TARGET AUDIENCE

  • Medical device manufacturers
  • Consultants 
  • Regulatory Affairs Specialists
  • Expert advisors in medical devices regulatory affairs
  • Working biomedical engineers / medical device professionals
  • Pursuing Students are also eligible

Duration: 2 Days (31st March & 1st April)

Location: Kalam Convention Center, AMTZ Campus, Vizag

Fee: INR 3,540 (Including GST)

Registration link: https://ibsc-amtz.in/coursedetails/25

Last Date For Registration: 25th March 2023
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For more information, please contact
Mr. Nitturi Naresh Kumar
Mobile: +91-8897330990
WhatsApp Link: https://wa.me/918897330990
trainings@amtz.in

Source: https://ibsc-amtz.in/coursedetails/25

Indian Business Delegation for Buyer Seller Meet (BSM) in ASEAN Region

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Indian Business Delegation for Buyer Seller Meet (BSM) in ASEAN Region from 27th Mar– 07th April, 2023

SEPC with the support of Department of Commerce, Ministry of Commerce & Industry, Government of India and recommendation by EP Services Division, is organizing India’s services sector trade delegation Buyer Seller Meet (BSM) to ASEAN region covering Indonesia, Philippines, Vietnam & Thailand from 27th March to 07th April, 2023 covering following sectors which have demand in ASEAN region:

➢ Accounting and Auditing Services

➢ Educational Services

➢ Healthcare Services

➢ Architectural, Construction & Related Engineering, Environmental Services

➢ KPO/ ITO Services

➢ Logistics Services

➢ Tourism Services

➢ Entertainment Services

➢ Other Professional services

Benefits you may get while participating at BSM to ASEAN region.

• Focused pre scheduled B2B meetings in each country

• Understand the market potential from experts in ASEAN region.

• Networking Opportunities with potential buyers in ASEAN region.

• Generate business leads and sign MOUs for collaborations.

• Meetings with relevant government and related stakeholders.

SEPC registered Members whose export turnover during the previous financial year is less than/up to Rs.50 crores (should not be zero) and who have completed one year of membership with SEPC will be eligible for assistance under new MAI scheme up to a maximum of Rs. 75,000/- towards economy class air fare, subject to terms and conditions of new MAI scheme and approval by the Ministry of Commerce & Industry

Click here to read more
Click here for Itinerary Details
click here for Registration

Health Ministry to rope in State Governments to establish Medical Devices Testing Laboratories

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Health Ministry to rope in State Governments to establish Medical Devices Testing Laboratories

The Ministry of Health and Family Welfare (MoHFW) is planning to rope in state governments also to establish or designate their existing laboratories as state medical devices testing laboratories and bring in enabling rules to support setting up of more testing laboratories for medical devices across the country as the sector is experiencing major regulatory paradigm shift including the introduction of a licensing regime.

A draft rule has been notified by the Ministry, under which it has proposed to insert a new sub-rule to the Rule 19, that the state government may, by notification, establish state medical devices testing laboratory for the purpose of testing and evaluation of medical devices or to carry out any other functions as may be specifically assigned to it.

The State Government may also designate any laboratory having facility for carrying out and evaluation of medical devices as state medical devices testing laboratory for the purpose, with a condition that the laboratory should be accredited by the National Accreditation Body for Testing and Calibration Laboratories (NABL).

It has also added a definition to the state medical devices testing laboratory, stating that it means a laboratory established or designated by the state government under the Rule 19(3), which is the freshly proposed sub-rule. While the Rule 19 was specifically for Central medical devices testing laboratory, it has been proposed for amendment by omitting the word ‘Centre’, this emphasising that the laboratories could be established either by the Central or the state government. The draft amendment is expected to be taken into consideration in seven days from the date of making the draft available to the public.

Click here to read more
Click here to read Notification

Source: http://www.pharmabiz.com/NewsDetails.aspx?aid=156725&sid=1

THE MEDICAL DEVICES RULES, 2017

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THE MEDICAL DEVICES RULES, 2017

The draft of the Medical Devices Rules, 2016 was published, as required under sub-section (1) of Section 12 and sub-section (1) of Section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), in the Gazette of India, Extraordinary, Part II, section 3, sub-section (i), vide notification number G.S.R. 983(E), dated the 17th October, 2016, by the Central Government.

All objections and suggestions received in response to the said draft notification have been duly considered by the Central Government; Now, therefore, in exercise of the powers conferred by Section 12 and Section 33 of the Drugs and Cosmetics Act, 1940 (23 of 1940), the Central Government, after consultation with the Drugs Technical Advisory Board, hereby makes the Medical Devices Rules, 2017

These rules shall, unless specified otherwise, come into force with effect from 1st day of January, 2018

These rules shall be applicable in respect of,—
(i) substances used for in vitro diagnosis and surgical dressings, surgical bandages, surgical staples, surgical sutures, ligatures, blood Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 2 of 248 and blood component collection bag with or without anticoagulant covered under sub-clause (i);
(ii) substances including mechanical contraceptives (condoms, intrauterine devices, tubal rings), disinfectants and insecticides notified under sub-clause (ii); and
(iii) devices notified from time to time under sub-clause (iv), of clause (b) of section 3 of the Drugs and Cosmetics Act, 1940 (23 of 1940).

Click here to read the Rules

Source:https://www.drugscontrol.org/pdf/Medical%20Devices%20Rules,%202017.pdf

Andhra Chamber – Business Delegation Tour

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Andhra Chamber – Business Delegation to Vietnam Expo April 2023

Andhra Chamber of Commerce has been organising Business Delegations to various countries for the members to explore export / business opportunities. Due to Covid 19 Pandemic, we could not organise the delegation in the last three years.

Vietnam is one of the fast-growing countries in Asia, even worldwide and now since the travel industry has also opened up, the Chamber is planning for a Business Delegation to Vietnam.

The Vietnam Expo happens every year and this year it is happening in the first week of April 2023. The Expo targets many sectors like Agricultural products, Food & Beverage, Machinery & Supporting industries, Digital technology & E-commerce; Electric & Electronics; Home Living, Trade promotion; Logistics & services etc.,

The details of the delegation along with the Registration form are enclosed and we invite you to be part of this Delegation to expand your business.

Last date of Registration is extended to 04th March 2023. Please fill up and send the registration form to enable us to enroll you for the Business Delegation to Vietnam.

For any further clarifications, please feel free to contact:

Ms.R.Vijayalakshmi
Secretary General,
Andhra Chamber of Commerce,
“Velagapudi Ramakrishna Bldg.”
No. 23, Third Cross Street,
West CIT Nagar, Nandanam,
Chennai-600035.
Phone: 24315278/79
Email: andhrachamber1@gmail.com
Web: http://www.andhrachamber.com

For Registration, Click here
To view Brochure, click here

Admission Open – Online Learning

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Call for Admissions – Online Skill Training Program on “Certificate in Biomedical Quality Assurance”

Call for Admissions – Online Skill Training Program on “Certificate in Biomedical Quality Assurance” 8th Batch starts from 18th March 2023. (NSDA Approved Course; Job Role No: 2019/HLT/AMTZ/3578)

Duration: 3 Months / 50 Hours (Online Lectures by Industry Experts – Saturday)

Sessions on Every Saturday 06:00 PM – 09:00 PM

Training Modules:
1) Global MDR
2) Indian MDR – 2017
3) USFDA
4) CE Certification
5) ISO 14971:2019
6) ISO 13485:2016
7) MDSAP

For Registrations, eligibility, application process & discounts please visit:

https://ibsc-amtz.in/coursedetails/10

Last Date for Registration 11th March
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For more information please contact
Mr. Nitturi Naresh Kumar
Mobile: 8897330990
WhatsApp Link: https://wa.me/918897330990
n.nareshkumar@ibsc-amtz.in

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