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Arazy Group Consultants Inc.

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Arazy Group Consultants Inc.

Our expertise is regulatory affairs and quality assurance for the medical device industry, culminatin Arazy Group Consultants Inc.

is a global, multifaceted regulatory affairs firm that provides all types of medical device manufacturers with innovative, client-specific solutions throughout the product life cycle – from early development to post-market activities. Arazy Group is constantly pursuing advanced solutions for the medical device industry and seeks to align its clients with the global economy and the ever-changing regulatory landscape. Please visit www.arazygroup.com or www.licensale.com for more information. Follow us on Twitter: https://twitter.com/arazygroup
Follow us on LinkedIn: http://www.linkedin.com/company/arazy-group

12/23/2025

Sending you warm Canadian hugs this Christmas 🎄
May your holidays be filled with warmth, joy, and moments that truly matter.
We wish you a season full of good cheer, peace, and a wonderful start to the year ahead.

Merry Christmas to you and your loved ones!

12/22/2025

China Accelerates Innovation with New High-End Medical Device Regulations

In July 2025, China’s NMPA issued Announcement No. 63, introducing measures to optimize lifecycle supervision and boost innovation for high-end devices such as medical robots, advanced imaging, AI-enabled devices, and novel biomaterials.

Key Highlights:

-Special approval pathways for breakthrough products enable faster market access.
-Updated classification, naming, and AI registration rules improve clarity and efficiency.
-Accelerated development of technical standards in robotics, imaging, and AI.
-Strengthened post-market oversight and lifecycle compliance for safety and quality.
-Promotion of regulatory science and real-world evidence to support global competitiveness.

Manufacturers should:

-Explore optimized approval pathways
-Align AI-enabled devices with updated registration requirements
-Prepare for enhanced lifecycle and post-market oversight

China’s updated regulations signal a more efficient, innovation-ready, and globally aligned environment for high-end medical technologies.

🔗 Subscribe for updates: https://hubs.ly/Q03YT0Rt0
Official details: https://hubs.ly/Q03YT4qD0

12/19/2025

2025 Was a Turning Point for Global MedTech Regulation

This year wasn’t about isolated updates; it was about modernization.

Across 12 RegTalk webinars, we saw the same trends shaping medical devices and IVDs worldwide:
• Fully digital regulatory systems
• Expanded UDI & traceability
• Stronger control of AI & digital health
• Modernized registration and renewal frameworks
• Greater reliance on global approvals

As we close 2025, one message is clear: regulatory strategy is no longer reactive; it’s strategic.

Watch the full global recap on YouTube: https://hubs.ly/Q03YN5410

Start 2026 informed, aligned, and ahead.

12/18/2025

Small RA teams don’t fail because of talent.
They struggle because of volume.

Too many markets.
Too many documents.
Too many deadlines.

Imagine this scenario:
A 3-person RA team, Class II diagnostic software, already FDA cleared and CE marked, planning expansion into 10 new markets in 2026:
Brazil, Japan, Korea, Saudi Arabia, China, Israel, Mexico, Canada, Australia.

That’s not a people problem.
That’s a structure problem.

A good AI roadmap shouldn’t add pressure or complexity.
It should remove it.

✔️ Clear priorities
✔️ A realistic pace
✔️ Momentum the team can actually sustain

We’ve outlined a practical 12-month AI roadmap designed specifically for small RA teams; no hype, no “AI experiments,” just a steady climb that delivers value early and compounds over time.

Read here the full article: https://hubs.ly/Q03YDNCt0

12/16/2025

South Korea Regulatory Update: Revision of Medical Device Standards

On August 27, 2025, South Korea’s Ministry of Food and Drug Safety (MFDS) issued Notice No. 2025-57, announcing a partial revision of the national Medical Device Standards. This update strengthens the safety and quality of medical devices distributed in Korea by aligning local technical requirements with international standards.

What’s new in this revision?

New standards introduced for 6 product categories, including:

-Dental silicone impression materials
-High-intensity focused ultrasound (HIFU) surgical devices
-These span medical supplies, dental materials, equipment, machinery, and Class I devices.

Updated testing and performance requirements for 17 device types, such as:

-Gas anesthesia machines
-Stationary incubators
-The revisions harmonize requirements with IEC and ISO methodologies.

Why this matters for manufacturers

✔️ More consistent device performance
✔️ Reduced potential health risks
✔️ Greater regulatory predictability
✔️ Stronger alignment with global compliance frameworks

The notice is issued under Article 19 of the Medical Devices Act and confirms that no additional budgetary measures are required.

Stay informed on the latest global regulatory changes; subscribe to our weekly newsletter:
🔗 https://hubs.ly/Q03YlWbB0

For the full MFDS guidance and official notice, visit:
🔗 https://hubs.ly/Q03YlQrg0

At Arazy Group, we help global manufacturers stay ahead of regulatory changes and achieve efficient, compliant market access across key markets worldwide.

12/11/2025

China Regulatory Update: Draft Expansion of UDI Requirements

On September 25, 2025, the NMPA released a draft proposing a significant expansion of the Unique Device Identification (UDI) system, moving China toward full lifecycle traceability for all medical devices.

The draft would extend UDI requirements to:

-All remaining Class II medical devices
-Class I medical devices
-Class I & II IVD reagents

Implementation Timeline
-Class II devices & all Class I–II IVDs: mandatory for products manufactured after June 1, 2027
-Class I devices: mandatory only for products manufactured after June 1, 2029

Devices made after these dates must upload UDI and packaging data to the NMPA database prior to market entry.

This expansion marks a major step toward comprehensive device traceability across China’s MedTech market.

At Arazy Group, we support global manufacturers in navigating evolving regulatory frameworks, ensuring efficient and compliant market access.

Watch the full update here: https://hubs.ly/Q03XX1tL0
Access more regulatory insights: https://hubs.ly/Q03XX4cG0

12/10/2025

Stay Ahead of 2025’s Most Important Regulatory Changes

Join our Regulatory Expert, Imane Jemal, on December 16, 2025, at 7:00 AM PST, for a special REGTalks session focused on the key regulatory updates expected across major global markets in 2025.

If you need a clear, concise, and high-value overview of what’s changing worldwide; and what it means for your market access strategy, this session will be especially relevant.

Register here to secure your spot: https://hubs.ly/Q03XMfwz0

12/09/2025

After outlining the five levels of AI adoption, the next question becomes inevitable: How do you measure real impact, and how do you know which level is right for your team?

In regulatory affairs, clarity matters. You need to understand what’s working, what’s truly moving the needle, and what’s simply noise.

In our full article, we share a practical, easy-to-apply framework that helps small RA teams evaluate their current AI maturity and plan their next steps with confidence:

-What should you measure?
-How can a small RA team identify the right AI level?
-What challenges appear when transitioning between levels?

Explore the full article here: The Path to AI-Ready Regulatory Affairs, https://hubs.ly/Q03X###Y0

12/08/2025

Singapore Releases Updated CSDT Guidance and Transitions to SHARE Platform

In October 2025, Singapore’s Health Sciences Authority (HSA) issued Revision 4 of GN-17 and GN-18, the updated guidance documents for preparing product registration submissions for general medical devices and IVD medical devices under the ASEAN CSDT format.

Highlights:

-Revision 4 formalizes the transition from the legacy MEDICS portal to the new SHARE platform, strengthening digital modernization with improved submission efficiency and document traceability.

-The update introduces a dedicated Machine Learning documentation section, establishing clear expectations for ML-enabled devices. Requirements include model architecture description, training and validation methods, performance evaluation, and risk management aligned with GL-04.

-Quality system provisions now mandate that ISO 13485 certificates be issued only by IAF-recognized accreditation bodies or EU MDR/IVDR-designated Notified Bodies.

-These enhancements align Singapore’s regulatory framework with global standards while reinforcing accountability for emerging digital health technologies.

Manufacturers submitting in Singapore should:

-Prepare for the full migration to SHARE for all regulatory applications
-Review new ML documentation expectations for AI/ML-enabled products
-Ensure ISO 13485 certificates meet updated acceptance criteria

As Singapore continues modernizing its regulatory ecosystem, these updates strengthen transparency, digital alignment, and readiness for next-generation medical technologies.

Stay informed on the latest global regulatory changes. Subscribe to our weekly newsletter:
🔗https://hubs.ly/Q03Xm7QN0

For the full guidance documents, visit the HSA Medical Device Regulation section: https://hubs.ly/Q03Xm7Sz0

12/04/2025

As we close another year of rapid change in global Regulatory Affairs, I want to take a moment to acknowledge the teams behind the work. To every RA professional navigating tighter timelines, new markets, and increasing regulatory complexity; your discipline and resilience are what keep innovation moving forward.

2026 is shaping up to be a pivotal year. AI has reached a maturity level where the degree of adoption directly translates into measurable time and budget impact; especially for small RA teams managing global workloads.

Take a common scenario: a 3-person RA team managing a Class II diagnostic software, already cleared in the U.S. and CE marked, preparing to expand into 10 new markets; Brazil, Japan, Korea, Saudi Arabia, China, Israel, Mexico, Canada, and Australia.

The question is no longer whether AI can help. It’s how far you want to go; and how much efficiency your team wants to unlock.

I’m inspired by the shift we’re seeing across the industry. RA teams are moving from manual, research-heavy workflows to AI-augmented systems that accelerate dossiers, streamline labeling, and reduce friction across global submissions. It’s not about replacing expertise, it’s about empowering it.

We’re entering a new chapter for Regulatory Affairs: one where smarter tools mean faster access to global markets, stronger compliance foundations, and more room for teams to focus on high-impact strategy.

Read the full article: The Five Levels of AI Adoption in Regulatory Affairs
https://hubs.ly/Q03WWKj60

12/02/2025

South Africa Releases Final Clinical Evaluation Guideline; What Manufacturers Need to Know

On September 8, 2025, SAHPRA issued Guideline SAHPGL-MD-16_v1, outlining updated requirements for the clinical evaluation of medical devices.

Key updates:

-Clear principles for planning clinical evaluations and selecting relevant data.
-Accepted evidence sources include literature, clinical investigations, post-market data, and comparable devices.
-Evaluator expectations aligned with ISO 14155 and ISO 14971.
-A structured Clinical Evaluation Report (CER) is now required to show conformity with Essential Principles.
-Ongoing updates to clinical evidence and enhanced benefit–risk and traceability requirements.

Why it matters:

This guideline strengthens South Africa’s clinical evidence framework and improves alignment with global regulatory standards.
Manufacturers should reassess their clinical evaluation procedures and documentation to maintain compliance.

Questions for the community:

Is your organization ready for SAHPRA’s updated clinical evidence expectations?
Does your CER process meet ISO-aligned rigor and traceability requirements?

Stay informed on global regulatory changes. Subscribe to our newsletter: https://hubs.ly/Q03WvT700
Official guideline: SAHPRA – Guidelines on Clinical Evaluation of Medical Devices
https://hubs.ly/Q03WvMZz0

12/01/2025

FDA QMSR Update: The Countdown to 2026 Has Begun

On February 2, 2026, the FDA’s new Quality Management System Regulation (QMSR) will officially take effect, marking one of the most significant U.S. regulatory transitions in decades.
This change brings FDA expectations into full alignment with ISO 13485:2016, and for manufacturers who haven’t begun preparing, the window of time is closing quickly.

What QMSR Means for Manufacturers

To support the industry through this transition, at Arazy Group we assist MedTech companies worldwide with:

-QMSR Gap Analysis
A structured review comparing your current QMS with QMSR requirements to identify missing elements and improvement needs.

-QMS Upgrade & Transition Planning
Hands-on support to develop and implement the updates needed across processes, documentation, and controls to achieve full compliance with QMSR and ISO 13485:2016.

-QMSR Audit Support
Independent validation to ensure your transition is complete and all gaps are closed.

If your organization hasn’t started the transition yet, now is the right time to begin to avoid compliance risks and operational delays.

At Arazy Group, we guide manufacturers through every step of this shift—ensuring a smooth, timely, and fully compliant transition.

Visit our website or contact our team to learn how we can support your QMSR transition with confidence: https://hubs.ly/Q03WmQYR0

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