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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

01/07/2026

Singapore Regulatory Update: R7 Licensing & QMS Requirements for Medical Device Dealers

In October 2025, Singapore’s Health Sciences Authority (HSA) released Revision 7 (R7) of GN-02, updating licensing requirements for manufacturers, importers, and wholesalers of medical devices. These changes are critical for companies ensuring compliant operations and market access in Singapore.

What’s New in R7?

SHARE Online Platform Mandatory: All licence-related applications, including new applications, amendments, renewals, withdrawals, and cancellations—must now be submitted exclusively via SHARE. No manual or mixed submission channels are accepted.

Stronger Applicant Responsibilities:
-Respond promptly to HSA input requests
-Keep contact and company information accurate
-Declare QMS certifications (ISO 13485, MDSAP, or GDPMDS)
-Importers/wholesalers handling non-Class A devices must be certified to GDPMDS or ISO 13485 by SAC-accredited bodies

Class A Device Updates:
-Dealers must submit a Product Notification via SHARE before import or supply
-Changes must be submitted as Amendments in SHARE
-Devices will appear in HSA’s Class A Medical Device Database for the first time

Licence Validity & Renewal
-Dealer licences now valid for 12 months
-Auto-renewal available for companies on GIRO
-Non-GIRO companies must submit renewal before expiry via SHARE
-Licences automatically invalid if not renewed on time

Why This Matters
-Ensures traceability for all medical devices
-Reduces risk of unlicensed dealings or regulatory delays
-Strengthens quality management oversight for importers and wholesalers

At Arazy Group, we help MedTech companies navigate Singapore’s evolving regulations, maintain compliance, and achieve efficient market access.

Watch the full update here: https://hubs.ly/Q03ZW3Nc0
Access more regulatory insights: https://hubs.ly/Q03ZW6Hk0

01/06/2026

Global Market Access: What’s the Smart Move for MedTech in 2026?

Expanding globally isn’t just about having a great medical device.
It’s about navigating regulatory complexity without friction, delays, or surprises.

After 30 years supporting MedTech companies worldwide, one thing is clear: Regulatory success depends on strategy, systems, and timing.

At Arazy Group, that journey is supported by two proven paths:

Two ways to scale globally, one regulatory goal

- LICENSALE
End-to-end regulatory support for product registration and post-market compliance, trusted across 140+ countries and regions.

- REGISLATE
For teams ready to manage registrations independently, with advanced tools that ensure accuracy, visibility, and control.

Whether you’re expanding into new markets or optimizing your current footprint, the right regulatory approach makes all the difference.

Explore how to simplify your global market access strategy:
https://hubs.ly/Q03ZL1mC0

01/05/2026

Japan Strengthens Global Alignment with PMD Act Regulatory Amendments

On October 31, 2025, Japan’s Ministry of Health, Labour and Welfare (MHLW) issued Cabinet Order No. 362, amending the enforcement regulations of the Pharmaceuticals and Medical Devices Act (PMD Act) as part of recently adopted legislative reforms.

These updates modernize regulatory procedures for medical devices and IVDs, with a strong focus on regulatory efficiency, international reliance, and post-market data generation.

Key Highlights:

-Introduction of priority review pathways leveraging regulatory reliance on approvals from equivalent jurisdictions.
-Updated approval and inspection procedures to streamline market entry.
-Enhanced framework for conditional approvals supported by post-marketing data.
-Strengthened post-market surveillance and real-world data requirements.
-Greater alignment with global regulatory practices to support innovation and faster access.

Manufacturers should:

-Assess eligibility for priority review through regulatory reliance
-Update approval and inspection strategies under the revised PMD Act
-Plan early for post-marketing data and lifecycle compliance
-Align Japan submissions with global regulatory strategies ahead of May 2026

Japan’s regulatory evolution signals a more agile, globally connected, and innovation-friendly environment for medical technologies.

🔗 Subscribe for updates: https://hubs.ly/Q03ZwY0r0
Official details: https://hubs.ly/Q03ZwX660

12/30/2025

As we welcome 2026, we want to say thank you for being part of the Arazy Group journey.

Your trust and collaboration mean a lot to us, and we’re grateful to be part of a growing global MedTech community. Wishing you and your loved ones a year filled with health, peace, and new opportunities.

We look forward to continuing the conversation in the year ahead.

12/29/2025

EU Regulatory Update: MDR & IVDR Borderline Classification – New Cases Added

In September 2025, the European Commission released an update to the EU Borderline & Classification Manual under MDR and IVDR, adding new cases that further clarify how certain products should be classified, or excluded, under EU medical device regulations.

This update focuses on borderline products, a critical area for manufacturers planning EU market entry or portfolio expansion.

What’s New in the Manual?
The newly added cases clarify that:

Red blood cell additive solutions with adenine
-Classified as Class III medical devices (Rule 14), as the medicinal substance is ancillary.

Dual-action creams with menthol & capsaicin
-Not medical devices, due to pharmacological action.

Vaginal lactose tablets
-Excluded from MDR, as the action is metabolic.

Microabrasion dental stain removers
-Not medical devices, since the purpose is cosmetic only.

Medical examination table covers
-Considered medical devices, due to their role in disease prevention.

Mobile sterile air systems
-Not classified as medical devices, as they act on the environment, not the patient.

Why This Matters

-Borderline classification errors can lead to:
-Delays in CE marking
-Incorrect conformity assessment routes
-Costly regulatory rework

These updates support more consistent classification decisions across the EU and highlight the importance of aligning intended use, mechanism of action, and regulatory strategy early on.

At Arazy Group, we help MedTech and IVD manufacturers interpret evolving MDR and IVDR guidance, reduce classification risk, and achieve efficient, compliant EU market access.

Watch the full update here: https://hubs.ly/Q03Z8bVJ0
Access more regulatory insights: https://hubs.ly/Q03Z8f1S0

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

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West Georgia
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Tuesday	9am - 5pm
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Friday	9am - 5pm

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http://arazygroup.com/

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