Arazy Group Consultants Inc.

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

Switzerland Regulatory Update: Swissdamed Registration Deadlines for Medical Devices & IVDsIn December 2025, Swissmedic ...
02/19/2026

Switzerland Regulatory Update: Swissdamed Registration Deadlines for Medical Devices & IVDs

In December 2025, Swissmedic and the European Commission issued official updates on Swissdamed and EUDAMED, impacting medical devices and IVDs in Switzerland:

Swissdamed system: Switzerland’s national database for medical devices and IVDs allows registration of economic operators and products placed on the Swiss market. It supports compliance monitoring, traceability, and market surveillance.

Mandatory registration deadlines:

-Economic operators have been required to register since 26 November 2021.
-Swissdamed has been technically available since August 2024 for familiarization.
-From 1 July 2026, registration of devices, systems, and procedure packs becomes mandatory. Products cannot legally be sold unless registered.
-A transition period runs until 31 December 2026, after which unregistered products will no longer be compliant.

Other key changes:

-Alignment with EU EUDAMED modules, confirmed fully functional on 27 November 2025, ensures regulatory consistency.
-Registration applies broadly to medical devices, IVDs, systems, and procedure packs.

Why it matters:
Ensures Swiss market compliance, strengthens traceability, reduces regulatory risk, and aligns Switzerland with EU regulatory timelines.

Watch the full update here: https://hubs.ly/Q043SpMs0
Access more regulatory insights: https://hubs.ly/Q043SsCN0

At Arazy Group, we help MedTech companies navigate Switzerland’s evolving regulations and ensure efficient market access.

Regulatory changes don’t send reminders.They just show up… in your submission timeline.Are you fully aligned with what’s...
02/18/2026

Regulatory changes don’t send reminders.

They just show up… in your submission timeline.

Are you fully aligned with what’s happening right now in India, Uzbekistan, Cuba, Mexico, United States, Ukraine, Thailand, and Vietnam, or are you reacting only after delays happen?

Join our 45-minute RegTalk on Google Meet on Tuesday, 24 February 2026 at 7:00 AM PST to get a clear, practical update on the latest regulatory changes across these markets; straight from our expert Imane Jemal. Ask your questions live and get actionable insights you can use immediately.

Tuesday, 24 February 2026
7:00 AM PST
⏱ 45 minutes
Live on Google Meet
💻 Free registration: https://hubs.ly/Q043DvFJ0

Which country update is most relevant for you? Drop it in the comments 👇

Regulatory Update in Mexico for Medical Devices and IVDs On January 15, 2026, Mexico published a Decree reforming the Ge...
02/17/2026

Regulatory Update in Mexico for Medical Devices and IVDs

On January 15, 2026, Mexico published a Decree reforming the General Health Law, introducing key updates for medical devices and in vitro diagnostics (IVDs).

-Extended Registration Renewal
Medical device registrations can now be renewed for up to 10 years, providing greater regulatory stability and long-term continuity for manufacturers and marketing authorization holders.

-Technovigilance Now Formalized
Article 262 Bis requires that once a device registration is granted, technovigilance activities must be conducted: monitoring device safety, identifying and evaluating incidents or adverse events, and tracking associated risk factors. This strengthens post-market oversight in a clear and explicit way.

-Flexible Inspection Modalities
COFEPRIS can perform inspections physically, documentarily, or electronically, creating a legal basis for remote or hybrid audits affecting manufacturers, importers, and authorized representatives.

These changes mark a significant step toward clearer, more stable regulations; aligning patient safety with industry efficiency.

Subscribe for updates: https://hubs.ly/Q043vRrq0
Source: https://hubs.ly/Q043vRsr0

We are pleased to share with our network and community that Arazy is present at MDI Expo 2026 in Israel.Miki, Piero, and...
02/17/2026

We are pleased to share with our network and community that Arazy is present at MDI Expo 2026 in Israel.

Miki, Piero, and Edit are representing Arazy on the ground, engaging in strategic discussions with industry leaders, manufacturers, and innovators who are shaping the future of medical technology.

MDI Expo serves as an important venue to discuss access to global markets, regulatory compliance, registration pathways, and the evolving challenges companies face when expanding internationally. Being present allows us to stay closely aligned with industry needs and directly connected to the professionals driving innovation, which is an essential part of our vision and long-term commitment.

At Arazy, we support medical device companies with structured regulatory strategies, efficient registration processes, and clear pathways into more than 140 markets worldwide. Behind every successful approval, a true Regulatory Rockstar is ensuring technical accuracy, compliance, and strategic ex*****on.

If you are attending the expo, we would be glad to connect.

You are also welcome to reach out through our digital platforms to schedule a meeting with our experts https://hubs.ly/Q043q80L0

or learn more about our services https://hubs.ly/Q043q7Z_0

02/13/2026

Arazy 集团恭祝大家新春快乐，万事顺意，马年大吉！

Happy Chinese New Year. As we welcome the Year of the Horse in 2026, it is a moment to celebrate energy, independence, and the drive to move forward, qualities that inspire us every day, both in our work and in life.

Like the Horse, the people we work with, colleagues, partners, and innovators, bring momentum, creativity, and determination to everything they do. Their passion shows us why progress is possible when we work together.

From all of us at Arazy Group, we wish you a year full of opportunities, growth, and meaningful moments. Let us embrace 2026 with optimism and purpose.

02/12/2026

Real approvals. Real impact.

There’s something powerful about seeing a medical device move from “strategy” to “registered” and then into the hands of the patients who need it.

Over the past weeks, we’ve celebrated new registration milestones across the Middle East.

And while approvals are often measured in certificates and timelines, what they really represent is:

Alignment
Regulatory clarity
Cross-border collaboration
Persistence

Expanding into new markets can feel complex, especially in regions with evolving regulatory frameworks. But growth doesn’t have to be a guessing game.

That’s why we developed the MARI Score, a practical tool designed to help MedTech companies assess their readiness for global expansion and make informed, strategic decisions before entering a new market.

Because regulatory strategy shouldn’t slow innovation down.
It should enable it.

If you’re evaluating your next market move, let’s start that conversation.

Learn more: https://hubs.ly/Q042X26r0

What if regulatory strategy was your growth advantage; not your biggest risk?That’s the mindset we’re bringing to Medica...
02/10/2026

What if regulatory strategy was your growth advantage; not your biggest risk?

That’s the mindset we’re bringing to Medical Device Israel (MDI Expo 2026).

Our CEO, Israel Office, Miki Melech, will be on site discussing how medical device companies can design regulatory pathways that support expansion, speed, and long-term control.

From independent license ownership and full lifecycle regulatory support to regulatory technology built on real global experience, our focus is clear:
helping companies scale internationally with predictability, clarity, and confidence.

If you’re attending MDI and thinking about your next target markets, let’s connect. Pre-booking available here: https://hubs.ly/Q042wFCR0

Egypt strengthens post-market oversight for medical devicesIn November 2025, the Egyptian Drug Authority (EDA) released ...
02/09/2026

Egypt strengthens post-market oversight for medical devices

In November 2025, the Egyptian Drug Authority (EDA) released Version 1 of its Medical Device Vigilance Guideline, establishing a national framework for post-market surveillance and vigilance covering medical devices and IVDs.

- Defines clear responsibilities for manufacturers, importers, distributors, users, and the Medical Devices Safety Unit (MDSU)
- Introduces structured requirements for incident reporting, trend analysis, FSCAs, PMSR, and PSUR
- Aligns Egypt’s system with IMDRF and EU vigilance principles

This development marks an important step toward greater regulatory harmonization, predictability, and patient safety across the device lifecycle in the Egyptian market.

For companies operating or planning market entry in Egypt, strengthening PMS and vigilance processes will be essential to maintain compliance under the new framework.

Subscribe for updates: https://hubs.ly/Q042lZYy0
Source: https://hubs.ly/Q042lYKT0

Kuwait Regulatory Update: New Pathways for Medical Devices & IVDsIn December 2025, Kuwait’s Ministry of Health issued Mi...
02/06/2026

Kuwait Regulatory Update: New Pathways for Medical Devices & IVDs

In December 2025, Kuwait’s Ministry of Health issued Ministerial Decree 387/2025, introducing three regulatory review pathways for medical devices and IVDs:

Standard: Full technical assessment for products not eligible for reliance or expedited review

Fast-Track: For urgent healthcare needs, relies on prior approvals from trusted authorities

Abridged: Leverages approvals from recognized regulators (FDA, EU CE, MHRA, Health Canada, PMDA, TGA, ANVISA) to reduce duplication and timelines

Other key changes:
-Electronic certificates accepted—less paperwork, faster processing
-Advanced technologies (software, nanomaterials, active devices) clearly regulated
-Authorized Representatives have stronger compliance and post-market responsibilities

Why it matters:
Streamlines submissions, reduces administrative burden, strengthens local oversight, and aligns Kuwait with global regulatory standards.

Watch the full update here: https://hubs.ly/Q0429HgK0
Access more regulatory insights: https://hubs.ly/Q0429Hmd0

At Arazy Group, we help MedTech companies navigate Kuwait’s evolving regulations and ensure efficient market access.

What you need to know about Brazil’s Regulatory Agenda 2026–2027On December 10, 2025, Brazil’s Collegiate Board (Dicol) ...
02/03/2026

What you need to know about Brazil’s Regulatory Agenda 2026–2027

On December 10, 2025, Brazil’s Collegiate Board (Dicol) of ANVISA approved the 2026–2027 Regulatory Agenda, defining the Agency’s priorities for the next two years. This agenda includes 161 priority topics, combining items carried over from the previous cycle, periodic updates, and newly introduced subjects from technical proposals and public consultation.

This is more than a list of topics; it reflects data-driven decision-making, transparency, and structured public participation.

Key highlights of the agenda:

-Medicines, food, and medical devices remain central focus areas.
-Cross-cutting regulatory matters address systemic challenges and opportunities.
-Public consultation and structured feedback mechanisms reinforce stakeholder involvement.
-Implementation progress will be monitored through ANVISA’s regulatory tracking and transparency platforms.

For professionals in regulated industries, this agenda provides predictability, insight into emerging regulatory trends, and a roadmap for strategic planning. Understanding these priorities will be critical for innovation, compliance, and market access over the next two years.

Discussion point: Which of these priority areas do you see as having the most impact on your sector, and how are you preparing to align with these regulatory priorities?

If you want to assess your readiness or align your global quality strategy, Arazy Group can help you navigate these changes: https://hubs.ly/Q041DtKR0

Full ANVISA Regulatory Agenda 2026–2027:
https://hubs.ly/Q041DtHd0

We’re looking forward to being at Medical Device Israel (MDI) and continuing the conversations around regulatory strateg...
02/02/2026

We’re looking forward to being at Medical Device Israel (MDI) and continuing the conversations around regulatory strategy as a growth enabler; not a bottleneck.

From independent license ownership and lifecycle support to regulatory technology grounded in real global experience, our focus remains the same:
helping companies scale internationally with control and predictability.

If you’re attending MDI and thinking about your next markets, let’s talk.
Pre booking is available at: https://hubs.ly/Q041k86Z0

EXPO

Were you unable to attend our regulatory update meeting on Wednesday, January 28?During this session, we reviewed key gl...
01/29/2026

Were you unable to attend our regulatory update meeting on Wednesday, January 28?

During this session, we reviewed key global regulatory developments that are currently shaping the medical device and IVD landscape. The discussion focused on how authorities across multiple regions are reinforcing regulatory oversight, updating approval pathways, and aligning more closely with international standards.

For those who could not join us live, the full recording and the main highlights are now available on YouTube:
Watch the session here: https://hubs.ly/Q040Yxkt0

The meeting covered recent regulatory updates from Egypt, the United Arab Emirates, Morocco, Kuwait, Switzerland, Malaysia, Turkey, and Canada, reflecting a broader global trend toward increased regulatory scrutiny, digitalization, and accountability.

These changes have direct implications for compliance planning and global market access strategies.

To stay informed, contact us: https://hubs.ly/Q040YDz-0

Address

West Georgia
Vancouver, BC
V6H3R9

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Monday 9am - 5pm
Tuesday 9am - 5pm
Wednesday 9am - 5pm
Thursday 9am - 5pm
Friday 9am - 5pm

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