Cybersecurity in Medical Devices

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.

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

One Person Company (OPC)

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

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

WORKSHOP ON INDIAN MEDICAL DEVICE REGULATIONS

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
➖➖➖➖➖➖➖➖
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

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

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

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.

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

THE MEDICAL DEVICES RULES, 2017

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).

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

Andhra Chamber – Business Delegation Tour

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

Admission Open – Online Learning

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

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

InformationUpdate

Industry Information Updates – Healthcare Sector