Global Regulatory Press

28/08/2024

*Regulatory News from Thailand: Have you heard about the simplified registration process for medical devices?
⭐️
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22/08/2024

*Regulatory News from Israel:

🚀Fast-track registration process launched for class II devices and medium risk IVDs

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20/08/2024

*Regulatory News from China:

📒Are you aware of the new IVD reagent “Classification Catalogue” that will become effective in January 2025?

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16/08/2024

🌻OUT NOW in the JMDR Bookstore:

🌻Medical device regulation in a changing world of sustainability awareness

Are you aware of the changing regulations regarding medical device environmental sustainability? Then you should read this new article from GlobalRegulatoryPress.com on:

🌻the evolving landscape of medical device regulation

🌻the increasing awareness of environmental sustainability

🌻how companies are adapting

🌻and what the future holds.

https://globalregulatorypress.com/product/medical-device-regulation-in-a-changing-world-of-sustainability-awareness/

£35

15/08/2024

🔎 OUT NOW in the JMDR Bookstore:

🔎 Implementation of Unique Device Identification (UDI) for medical devices around the world

🔎 A tabulated summary of the UDI requirements for Australia, Brazil, China, Egypt, the European Union, India, Korea (Republic of), Malaysia, Saudi Arabia, Singapore, Taiwan, Turkey and the USA.

Includes hyperlinks to the legislation.

Buy now: https://globalregulatorypress.com/product/implementation-of-unique-device-identification-udi-for-medical-devices-around-the-world/
£35

14/08/2024

💥OUT NOW in the JMDR Bookstore:

💥Best practices for medical device cybersecurity planning from a US perspective

Are you responsible for your company's cybersecurity planning? Then you should read this article on cybersecurity planning under US law from GlobalRegulatoryPress.com.

The article considers:
💥best practice solutions for manufacturers to consider in their cybersecurity plans
💥how a company should plan for cybersecurity documentation in an FDA submission
💥required cybersecurity documents
💥guidance on how device manufacturers should prepare for the path forward.

13/08/2024

💥Out Now in the JMDR Bookstore:
💥PMDA overview of the review systems for innovative medical devices in Japan
💥Are you responsible for medical device approval in Japan?

Then you should read this overview of the newly enforced systems for innovative device review from GlobalRegulatoryPress.com, which are particularly relevant to SaMD and AI-based systems.

Buy now from the JMDR Bookstore:
https://globalregulatorypress.com/product/pmda-overview-of-the-review-systems-for-innovative-medical-devices-in-japan/

£35

08/08/2024

"Regulatory News from UK":

Are you aware of the intention to continue using dental amalgam in Northern Ireland for patients residing in the UK?

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05/08/2024

*Regulatory News from Switzerland*:

Did you see that the Swissdamed actors’ module will become live tomorrow 6 August 2024?

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22/07/2024

*Sneak Preview JMDR August 2024 issue*
🔒Best practices for medical device cybersecurity planning from a US perspective
🔒The medical device cybersecurity landscape continues to evolve rapidly with increasing medical device connectivity and an increased frequency and severity of cybersecurity threats to the healthcare sector. Cybersecurity threats that target medical devices can render medical devices and hospital networks inoperable, shut down healthcare operations, delay critical patient care, reveal sensitive patient data, and necessitate costly recovery efforts. Given this, the need for robust cybersecurity controls to ensure medical device safety and effectiveness has become increasingly important for the entire medical device community and all stakeholders.

In this article, Shilpa Rapaka looks at what the new Food and Drug Administration (FDA) pre-market cybersecurity guidance means for device manufacturers, and offers some best practice solutions for manufacturers to consider in their cybersecurity plans.

The article also clarifies how a company should plan for cybersecurity documentation in an FDA submission, and details the required cybersecurity documents. It also discusses how device manufacturers should prepare for the path forward.

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https://globalregulatorypress.com/our-shop/buy-a-subscription-to-the-jmdr/

18/07/2024

🎙️ Discover Expert Insights on the Journal of Medical Device Regulation's Podcasts!
Have you explored our free podcast series? Leading experts in the medical device regulatory field share their valuable insights and in-depth knowledge on the trending topics and best practices. Whether you're a seasoned professional or just starting out, these podcasts offer a wealth of information to keep you informed and ahead in the industry.
Don't miss out – tune in today!
https://globalregulatorypress.com/services/medical-device-podcasts/

12/07/2024

*Sneak Preview JMDR August 2024 issue*

🔎Chart: Implementation of Unique Device Identification (UDI) for medical devices around the world

A tabulated summary of the UDI requirements, with hyperlinks to the legislation, for Australia, Brazil, China, Egypt, the European Union, India, Korea (Republic of), Saudi Arabia, Singapore, Taiwan, Turkey and the USA.

🔎https://globalregulatorypress.com/our-shop/buy-a-subscription-to-the-jmdr/

10/07/2024

🌿Sneak preview JMDR August 2024 issue:

*Medical device regulation in a changing world of sustainability awareness*

🌿The global medical device market has grown increasingly over the years and is projected to hit a staggering US$800 billion by the year 2030. This massive growth in the industry, which is undoubtedly due to its strategic importance in healthcare, comes at a substantial cost to the environment.

With environmental sustainability becoming an increasingly important topic in the world today, the environmental impact of the device industry has come under more scrutiny, prompting slight changes in regulations which factor in these concerns.🌿

This shift towards the environmental regulation of medical devices presents the unique challenge of satisfying sustainability requirements without compromising patient safety.

Akor Agada’s article looks at the evolving landscape of medical device regulation, the increasing awareness of environmental sustainability, how companies are adapting, and what the future holds.

Subscribe now to read the full story:
🌿https://globalregulatorypress.com/our-shop/buy-a-subscription-to-the-jmdr/

24/06/2024

*Cybersecurity Insights - Special Offer*
Buy
"Medical device cybersecurity requirements in the USA" and receive a copy of
"Software documentation: requirements of IEC 62304 versus US FDA guidance"
*absolutely FREE*!
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https://globalregulatorypress.com/product/medical-device-cybersecurity-requirements-in-the-usa/

11/06/2024

*Regulatory News from

📌Korea (Republic of): Did you see that the new “Digital Medical Products Act“ was published?

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19/02/2024

⚡️Regulatory News from USA: Make sure to examine the Final guidance for industry entitled "Digital Health Technologies for Remote Data Acquisition in Clinical Investigations".

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16/02/2024

*Out now available from Global Regulatory press*

⚡️Defining the right regulatory framework for conducting research in France

Does your company conduct research in France? Then you should read this new article on:
⚡️Health data protection
⚡️Different types of research in France: Research Not Involving a Human Person, Research Involving a Human Person and Clinical investigation
⚡️Authorisation stages and associated timeframes

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https://globalregulatorypress.com/product/defining-the-right-regulatory-framework-for-conducting-research-in-france/

15/02/2024

Out now available from Global Regulatory Press:

⚡️*EUDAMED: Important considerations for ensuring preparedness and compliance*

Are you in charge of implementing the EUDAMED requirements in your company? Find valuable information on how to prepare your company in this new article, which will help you understand:

⚡️Timelines and deadlines
⚡️Data management
⚡️Actor Registration (ACT) module
⚡️Notified Bodies and Certificates (CRF) module
⚡️UDI and Device Registration (UDID) module
⚡️Clinical Investigation/Performance Studies (CI/PS) module
⚡️Vigilance/Post-Market Surveillance (VGL) module
⚡️Sources of EUDAMED Information

Buy now to read the full story:
https://globalregulatorypress.com/product/eudamed-important-considerations-for-ensuring-preparedness-and-compliance/

14/02/2024

💥IVDR implementation – important lessons to learn and apply

Are you in charge of implementing the IVDR requirements for your company's products? Learn essential lessons from this new article from GlobalRegulatoryPress.com, which will help you understand:

⚡️Benefits of early submission
⚡️Transitional arrangements
⚡️Clinical evidence
⚡️PMS and PMPF
⚡️Challenges posed by the transition periods
⚡️New features of the IVDR

https://globalregulatorypress.com/product/ivdr-implementation-important-lessons-to-learn-and-apply/

13/02/2024

22/01/2024

*Sneak Preview February 2024 issue*:

⭐️EUDAMED: Important considerations for ensuring preparedness and compliance⭐️

The European database on medical devices (EUDAMED) is considered the digital backbone for the European Union’s (EU’s) regulatory framework for medical technologies – Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). EUDAMED is pivotal for the overall functioning of the framework and serves as a comprehensive repository for information relating to the entire lifecycle of medical devices that meet the provisions of the MDR or IVDR to be placed on the Union market. In this article, Olga van Grol-Lawlor and Frank Matzek summarise the objectives of EUDAMED’s six distinct but interconnected modules, clarify the current deployment timeframes, and explain what information will be publicly accessible. They also recommend points to consider when developing a EUDAMED strategy, including methods for communicating data to EUDAMED.

https://globalregulatorypress.com/our-shop/buy-a-subscription-to-the-jmdr/

15/01/2024

⭐️Sneak Preview JMDR February 2024 issue:⭐️

*An overview of the medical device regulations in the Islamic Republic of Iran*

This article by Ilona Putz summarises the responsibilities of the regulatory authority, the legal framework for device regulation in Iran, and the definition of a medical device. It then sets out the rules for classification and product registration/importation, as well as related documentation requirements. The article also discusses approval timelines and fees, post-market variations and renewals, packaging and labelling requirements, vigilance, and post-market surveillance requirements.

Subscribe now to read the full story - available on 1 February 2024:

👉https://globalregulatorypress.com/our-shop/buy-a-subscription-to-the-jmdr/

05/12/2023

Regulatory News from
⚡️Argentina: Are you aware of the new requirements for Good Technovigilance Practices?

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30/11/2023

FREE ARTICLE:

💥*Planning, designing and implementing high-quality (Level 4) post-market clinical follow-up surveys*

Since the implementation of the European Medical Device Regulation (MDR), device manufacturers are required to be more proactive in assessing the safety and performance of their products, backing this up with clinical data and post-market monitoring. The data collected are then used to update risk management and the clinical evaluation of each device. Post-market clinical follow-up (PMCF) surveys have become a hot topic across the industry, as they offer a cost-effective solution for PMCF data collection, albeit implementing them effectively can be troublesome. This article by Marcus Torr, Martha Vakalopoulou-Paschalidou, Tonika Chester, Chris Webb and Tom Melvin focuses on high-quality, case/patient specific PMCF surveys, providing Level 4 data, and outlining how to plan, design and implement these for successful submission to the Notified Bodies and for MDR certification.

This article has been published in the November 2023 issue of the Journal of Medical Device Regulation and is made available free of charge by the authors.🙏

👉 https://globalregulatorypress.com/product/planning-designing-and-implementing-high-quality-level-4-post-market-clinical-follow-up-surveys/

21/11/2023

Regulatory News from
👀Sweden: Check out the new guidance and checklist on the use of AI in Swedish Healthcare

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👉 https://globalregulatorypress.com/our-shop/buy-a-subscription-to-the-jmdr/

16/11/2023

Get your copy of

*Requirements of IEC 62304 versus US FDA guidance ‘Content of Premarket Submissions for Device Software Functions’*

Are you dealing with documentation requirements for medical device software? If so, you should read the new reference chart from Global Regulatory Press, which will help you understand:

⚡️the differences and similarities between the documentation requirements of IEC 62304 and the latest FDA guidance on software

⚡️differences in terminology

⚡️how to create internal documentation deliverables that meet both the FDA and the IEC requirements

👉 https://globalregulatorypress.com/product/software-documentation-requirements-of-iec-62304-versus-us-fda-guidance-content-of-premarket-submissions-for-device-software-functions/

15/11/2023

Get your copy of: "An overview of the regulatory requirements for medical devices in Colombia"

Are you dealing with marketing authorisation in Latin America, especially in Colombia? This new article will help you understand:

⚡️Colombia's risk classification for medical devices
⚡️the process for obtaining a marketing authorisation
⚡️documents that must be submitted with an application
⚡️fees and timeframes
⚡️responsibilities of manufacturers and importers in Colombia’s national technovigilance programme

👉https://globalregulatorypress.com/product/an-overview-of-the-regulatory-requirements-for-medical-devices-in-colombia/