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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 re

gulatory 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

05/01/2026

Regulatory Update in Russia: Alcohol-Containing Medical Devices

What happens when regulatory clarity meets operational reality?

On February 6, 2026, the Russian government issued Resolution No. 194-r, quietly refining how alcohol-containing medical devices are treated under national regulation.

Here’s what matters

-Refined Scope of Exemptions
The updated resolution revises the official list of alcohol-containing medical devices exempt from state control on ethyl alcohol; bringing greater precision to what qualifies.

-Expanded Coverage for IVDs & Lab Kits
New entries, primarily in vitro diagnostic reagents and laboratory kits, have been added, with detailed specifications including intended use, configurations, and registration references.

-Removal of Legacy Entries
Certain previously listed products have been excluded, signaling a move toward a more curated and accurate regulatory classification.

-No New Regulatory Burden
While the scope is clearer, the framework itself remains unchanged, maintaining exemption status without introducing additional compliance requirements.

Why it matters
This update reflects a broader regulatory trend: tightening definitions without increasing friction, especially for products involving controlled substances like alcohol.

For manufacturers and regulatory teams, clarity like this can directly impact classification, documentation, and market access strategy.

Need support navigating regulatory updates in Russia or globally?
Let’s connect. https://hubs.ly/Q04f8qnB0

Subscribe for updates: https://hubs.ly/Q04f8rDk0
Source: https://hubs.ly/Q04f8Fh_0

04/29/2026

Regulation is changing faster than most companies are able to keep up with, and the gap is widening.

During our latest RegTalk, three major shifts made this especially clear:

-Regulatory scope is expanding rapidly
Software, IVF devices, and IVDs are increasingly being pulled into stricter approval pathways and conformity assessment frameworks, reshaping what “regulated product” even means.

-Compliance doesn’t end at approval anymore
Post-market surveillance has become continuous and data-driven—UDI tracking, adverse event reporting, change control, and full lifecycle oversight are now core expectations, not add-ons.

-Flexibility is increasing, but so is complexity
We’re seeing faster and more adaptive pathways (RWE, product grouping, simplified approvals), while at the same time facing tighter controls on classification, cybersecurity, advertising, and technical documentation.

This is not just regulatory evolution; it’s a structural shift. More pathways to market, but significantly higher expectations across the entire product lifecycle.

Regulatory strategy is no longer about reacting to change.
It’s about anticipating it and turning it into a competitive advantage.

Missed the session? Watch it here: https://hubs.ly/Q04dWGx60

Let’s connect: https://hubs.ly/Q04dWJMl0

04/28/2026

What if your next market opportunity isn’t in one region… but happening globally at the same time?

This wave of regulatory updates across the UK, Canada, and the Philippines is reshaping how MedTech companies approach market access, compliance, and lifecycle strategy.

-The United Kingdom is moving toward long-term recognition of CE-marked devices, with the Medicines and Healthcare products Regulatory Agency considering indefinite CE acceptance to reduce duplication and improve continuity of supply.

-Canada is strengthening its medical device licensing system, as Health Canada introduces a more structured, transparent framework for MDL applications, lifecycle management, and digital submissions.

-The Philippines is refining its post-approval change system, with the Philippine Food and Drug Administration implementing a clearer risk-based classification for variations, especially for software and digital health updates.

Together, these shifts point in the same direction:
more clarity, more risk-based decision-making, and more efficient pathways for innovation to reach patients.

If global expansion is part of your strategy, staying ahead of these changes is no longer optional.

Watch the highlights in our latest reel.

Stay up to date with regulatory changes and market insights:
Subscribe to our newsletter: https://hubs.ly/Q04dLXWd0

04/27/2026

No one talks about this in regulatory teams:

The problem isn’t complexity. It’s being late.

-Late to interpret.
-Late to adapt.
-Late to submit.

And by the time you react…Someone else is already in the market.

That’s how opportunities disappear quietly.

Tomorrow, we’re going market by market and breaking down what’s changing BEFORE it hits you: South Korea, Australia, Philippines, South Africa, Russia, Brazil, India, Chile

No theory.
No recycled updates.
Just what actually impacts your timelines.

📅 April 28, 2026
⏰ 8:00 AM PST
⏱️ 45 min | Live

Register here: https://hubs.ly/Q04dB1xX0

Quick pulse check. Are you reacting to changes… or actually ahead of them?

04/22/2026

Most regulatory teams think they’re on top of everything. They’re not.

Updates get missed, interpretations come late, and submissions get delayed. That’s when market access quietly turns into a bottleneck.

On April 28, we’re breaking down the regulatory changes most teams only notice when it’s already too late across South Korea, Australia, Philippines, South Africa, Russia, Brazil, India, and Chile.

Join our next RegTalk and get ahead of what’s coming, not after it hits your pipeline.

Tuesday, April 28, 2026
8:00 AM PST | 45 minutes | Live session

Free registration: https://hubs.ly/Q04d5bM_0

If you’re managing multiple markets, this isn’t optional; it’s risk management.

Be honest, which country is slowing you down the most right now?

04/20/2026

Regulatory Update in the EAEU for Medical Devices

Regulatory simplification is gaining momentum in the Eurasian Economic Union, and it could directly impact your market access strategy.

In February 2026, EAEU member states signed a Protocol amending the Agreement on Unified Principles and Rules for the Circulation of Medical Devices within the Union.

What’s changing, and why it matters:

Expanded exemptions from registration
The updated framework broadens the list of devices that do not require mandatory registration, including:
-Custom-made devices for individual patients
-Devices imported for emergency or life-saving use
-Devices manufactured within the EAEU for export to third countries
-Certain kits and sets containing already registered products

Improved regulatory clarity
The amendments aim to reduce ambiguity and streamline compliance requirements across member states; a key step toward harmonization.

Implementation timeline
The Protocol has been provisionally applied since February 19, 2026, and will formally enter into force once all member states complete internal procedures.

Why this matters for MedTech companies
Fewer registration requirements in specific scenarios can translate into:
-Faster market access
-Reduced regulatory burden
-More flexibility in emergency and export-driven strategies

But navigating exemptions correctly is critical; misinterpretation can still lead to delays or compliance risks.

Are you leveraging EAEU exemptions effectively in your regulatory strategy?
Let’s talk: https://hubs.ly/Q04cNnBx0

Source: https://hubs.ly/Q04cNsVz0

04/16/2026

UK Regulatory Update: CE Mark recognition could be here to stay

The UK is rethinking its strategy, and it could change market access for MedTech.

The MHRA is considering indefinite recognition of CE-marked devices in Great Britain.

Why now:
~90% of devices are still CE marked
UKCA transition remains slow
Ending CE recognition could risk supply shortages

What’s being proposed:
-Extend legacy MDD devices until 2028
-Allow ongoing recognition under MDR/IVDR
-Introduce a streamlined pathway for higher-risk devices

What this signals:
A shift from regulatory independence → practical alignment.

Why it matters:
-Less duplication.
-Faster access.
-More predictable pathways into the UK market.

A key moment for MedTech companies operating globally.

At Arazy Group, we help companies stay ahead of regulatory change and accelerate market access.

Watch the full update: https://hubs.ly/Q04crPGJ0
More insights: https://hubs.ly/Q04crVNh0

04/14/2026

Philippines FDA Tightens Rules for Post-Approval Changes in Medical Devices (2025)

Post-approval changes just became clearer in the Philippines.

The FDA Philippines (CDRRHR) has issued a draft circular introducing a new framework for managing variations to medical devices, IVDs, and health-related devices.

This update aligns with Republic Act No. 9711 and aims to bring more structure, predictability, and a risk-based approach to regulatory decision-making.

The key change is a clearer classification of variations into major, minor, and notification-based updates, including specific rules for Medical Device Software.

It also formalizes a risk-based system where the regulatory pathway depends on the impact of the change on safety, performance, and quality. Low-risk updates can follow simplified processes, while higher-risk changes require full review.

The FDA further strengthens guidance on submission requirements, review timelines, fees, deficiency handling, and lifecycle management, including labeling, renewals, and post-market obligations.

Software updates receive special attention, reflecting the growing role of digital health in medical devices.

Overall, this update improves clarity, consistency, and efficiency in how post-approval changes are handled in the Philippines.

For manufacturers, this means faster pathways for low-risk changes and stronger expectations for compliance and documentation.

At Arazy Group, we help MedTech companies navigate global regulatory complexity and accelerate market access with confidence.

Need support with regulatory strategy or market access in the Philippines?
Let’s connect: https://hubs.ly/Q04b_DdQ0

Source: https://hubs.ly/Q04b_Cx20

04/08/2026

Regulatory Update in India for Medical Device Software (MDS)

In October 2025, India’s Central Drugs Standard Control Organization (CDSCO) released a draft guidance on Medical Device Software (MDS), providing much-needed clarity on how software is regulated under the Medical Device Rules, 2017.

This guidance reflects India’s continued alignment with global regulatory trends, particularly in the evolving digital health landscape.

– Regulatory Scope
The document defines how software is regulated as a medical device, covering both Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD), in line with international regulatory principles.

– Risk-Based Classification & Requirements
A structured framework is introduced based on risk classification (Classes A–D), including expectations for quality management systems, clinical evaluation, and software verification and validation.

– Emerging Technologies
Specific considerations are outlined for AI/ML-based software, cybersecurity, and cloud-based solutions—highlighting the growing importance of digital innovation in healthcare.

– Lifecycle & Post-Market Expectations
The guidance details requirements for post-market surveillance, software updates, and change management, ensuring ongoing safety and performance throughout the product lifecycle.

– Regulatory Pathways
Clear licensing pathways and documentation expectations are provided, without introducing new regulatory obligations beyond the existing framework.

These developments reinforce India’s commitment to a more structured, transparent, and globally aligned regulatory environment, supporting innovation while maintaining patient safety.

How do you see India’s approach to regulating digital health evolving in the coming years?

Need support with regulatory strategy or market access in India?
Let’s connect: https://hubs.ly/Q04b1-sN0

Source: https://hubs.ly/Q04b1wH-0

04/07/2026

Japan Regulatory Update: Material Change Procedures for Medical Devices

Japan has updated its framework for managing post-approval changes to medical devices, bringing more clarity, structure, and efficiency to how material changes are handled.

What’s new:

Clear classification: The updated guidance introduces well-defined criteria to distinguish between minor and major changes, helping manufacturers choose the correct regulatory pathway.

Focus on materials: Applies specifically to materials that interact with the human body; including both direct contact (e.g., implants) and indirect contact (e.g., fluid pathways).

Simplified pathway for minor changes: A new notification-based approach allows low-risk material changes to proceed without full approval; as long as safety, quality, and performance remain unaffected.

Defined limits: Changes are not considered minor if they introduce new risks, increase existing risks, impact clinical performance, or are linked to adverse events.

Manufacturer accountability: A self-declaration is now required for minor changes, confirming that proper evaluation and risk assessment have been completed.

Documentation still critical: Even without full submission, manufacturers must conduct testing and retain all supporting evidence, available for review during inspections.

Why it matters:
This update enables a more risk-based and efficient approach to post-approval changes in Japan, reducing regulatory burden for low-risk updates while reinforcing accountability and compliance expectations.

At Arazy Group, we help MedTech companies stay compliant and move faster in global markets.

Watch the full update here: https://hubs.ly/Q049VppY0
More regulatory insights: https://hubs.ly/Q049VrGZ0

04/02/2026

Happy Easter, everyone! 🌿

Wishing you a joyful and restful long weekend surrounded by those who matter most.

This season is a meaningful reminder of renewal, hope, and new beginnings; an opportunity to pause, reflect, and appreciate both personal and professional growth.

May this time bring you fresh energy, inspiration, and continued success in the months ahead.

Enjoy the long weekend and the simple moments that make it special.

03/31/2026

Regulatory Update in Canada for Medical Devices

In 2025, Health Canada issued the guidance document “Guidance on Managing Applications for Medical Device Licences”, effective February 2, 2026.

This new guidance provides a comprehensive framework for managing Medical Device Licence (MDL) applications under the Medical Devices Regulations, covering Class II, III, and IV devices.

– Regulatory Scope
The guidance applies to new applications, amendments, and private label submissions, aiming to enhance consistency, predictability, and transparency in the review and authorization process.

– Submission & Review Framework
It outlines administrative, regulatory, and technical screening stages, including classification-based pathways and defined performance timelines for market authorization.

– Lifecycle Management
Clear processes are established for handling deficiencies, clarification requests, additional information, withdrawals, refiling, and reconsideration mechanisms.

– Compliance & Digital Submissions
The document also details electronic submission requirements, applicable fees, and compliance expectations to ensure devices meet safety, effectiveness, and quality standards throughout the review process.

These updates reinforce Canada’s commitment to a structured, transparent, and efficient regulatory system, supporting timely access to safe and effective medical technologies.

Need support navigating Health Canada MDL applications or regulatory strategy in Canada?
Contact our team: https://hubs.ly/Q0494LSd0

Source: https://hubs.ly/Q0494Xx40

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