Arazy Group Consultants Inc.

10/23/2025

Canada Regulatory Update: Guidance on Application Types for Medical Devices

On August 29, 2025, Health Canada released the "Guidance for Determining Medical Device Application Type," providing manufacturers with clarity on structuring device submissions under the Medical Devices Regulations.

This guidance categorizes devices into five application types:

-Single Device: A standalone product.
-Family: Devices sharing the same design and intended use but differing in attributes like size or color.
-Group: A collection of devices under a single identifier, such as a surgical tray.
-Group Family: Multiple groups from the same manufacturer, differing only in the combination or number of products.
-System: Integrated devices working together for a common purpose, like a diagnostic imaging system.

Manufacturers are encouraged to document their application structure rationale in the cover letter of their submission, referencing the relevant sections of the regulations.

This guidance aims to streamline the submission process, ensuring consistency and compliance with Health Canada's regulatory framework.

At Arazy Group, we assist MedTech companies in navigating complex regulatory landscapes, ensuring timely and efficient market access.

📽️ Watch the full update here: https://hubs.ly/Q03PPW9s0

📙 Access more regulatory insights: https://hubs.ly/Q03PPVv00

10/21/2025

🖥️ October 28 | 8:00 AM PST | Free Online Event
MedTech Regulations 2025 and Beyond: Global Insights You Can’t Miss

MedTech regulations continue to evolve worldwide: Are you ready to navigate the next wave of changes?

Join Arazy Group’s RegTalk Webinar with Regulatory Affairs expert Imane Jemal, who will deliver essential updates from:
Thailand · Russia · India · Honduras · EAEU · Malaysia

What you will gain:

-Key regulatory updates and their potential impact on your global strategy
-A forward-looking perspective on regulatory changes expected in 2025 and beyond
-Live Q&A session to address your specific regulatory challenges

In just 45 minutes, gain practical insights to strengthen your submissions and guide your market expansion strategies with confidence and clarity.

Register here: https://hubs.ly/Q03Pzdzg0

10/20/2025

Singapore Updates FSCA Guidance for Medical Devices – Key Highlights

On July 11, 2025, Singapore’s Health Sciences Authority (HSA) issued Revision 4 of Guidance GN‑10 on Field Safety Corrective Action (FSCA), introducing new definitions and expanded reporting requirements.

Key updates:

-Qualified practitioner defined; all FSCA submissions now electronic via OSCAR with acknowledgment notices.

-MDRR1 reports must include health hazard assessments, root cause analyses, CAPA validation, consignee/supply data, and draft print ads.

-Implantable devices: FSNs sent to qualified practitioners with confirmation of implantations.

-Consumer FSCAs require public print ads with minimum content.

-Follow-up/final reports must cover stock reconciliation, declarations, acknowledgment receipts, and service/destruction records.

-Risk framework distinguishes recalls, prohibits new supply of recalled devices, and allows conditional supply under mitigation measures.

Why it matters:
Strengthens Singapore’s FSCA framework, aligning it with global best practices. Manufacturers and distributors should update FSCA procedures, QMS/CAPA systems, and reporting workflows.

Questions for the community:

-How is your company preparing for these FSCA updates?
-Do you have systems to manage follow-ups, notifications, and practitioner acknowledgments efficiently?

Stay updated with regulatory developments worldwide. Subscribe to our weekly newsletter: https://hubs.ly/Q03Pp4Qq0

For more details, visit the HSA Medical Device Guidance Documents page on the agency’s official website: https://hubs.ly/Q03Pp9wm0

10/16/2025

MedTech Regulatory Roundup: Canada & Egypt

Regulatory clarity is accelerating, and staying informed means staying compliant.

In Canada, Health Canada has released new guidance clarifying how medical device applications should be structured. Manufacturers must now justify in their cover letter whether their submission represents a single device, a family, a group, or a system.

For example, a catheter and guide wire packaged together count as a single device. Sold separately, they form a system. Different sizes of the same stent are considered a family, while a surgical tray qualifies as a group. The same logic applies to IVDs such as glucose meters or HIV test kits. The key takeaway: a change in how a product is grouped could require a new application.

In Egypt, the Egyptian Drug Authority (EDA) announced on June 25, 2025, new measures to simplify medical device registration. EDA now accepts ISO 13485, CE (MDR), or GMP certificates, as long as they cover the actual manufacturing site. For companies still holding CE (MDD) certificates, submissions remain possible if accompanied by an extension letter and a formal declaration of compliance.

The objective is clear: streamline compliance and align with EU frameworks to make market access faster and more predictable.

At Arazy Group, we help MedTech companies not only keep up with regulatory changes, but stay ahead of them. Let’s make your global market access easier.

📙 Learn more: https://hubs.ly/Q03N_q_40

10/15/2025

China Releases 38 New or Revised Medical Device Standards

On June 25, 2025, China’s National Medical Products Administration (NMPA) announced the publication of 38 new or revised industry standards for medical devices spanning dentistry, traditional Chinese medicine devices, diagnostic reagents, imaging systems, implants, surgical instruments, and medical software.

Highlights:

-The publication includes 22 newly formulated and 16 revised standards, such as those for blood thawing devices, SMN gene test kits, exoskeleton robots, digital intraoral X-ray systems, CT scanners, implantable defibrillators, and reusable oral surgical instruments.

-Implementation dates range from July 1, 2026, to July 1, 2028, with diagnostic and software standards taking effect earlier and dental/implantable device updates following later.

This update underscores China’s ongoing push toward technical harmonization, stronger post-market oversight, and alignment with global regulatory frameworks.

Manufacturers operating in China should:
-Review conformity documentation
-Update testing protocols
-Strengthen quality and compliance systems to meet the new standards on time

China’s ongoing regulatory modernization reflects a wider regional trend, Asian markets are moving toward more transparent, harmonized, and innovation-driven medical device frameworks.

Stay updated with regulatory developments worldwide. Subscribe to our weekly newsletter: https://hubs.ly/Q03NL6QW0

For more details, visit the NMPA Medical Device Regulation section on the agency’s official website: https://hubs.ly/Q03NLzwJ0

10/15/2025

In the age of AI, what role remains for human expertise?

AI can summarize regulations, outline compliance steps, and even generate roadmaps.
But in a world overflowing with information… how do we judge its accuracy?

This is the new reality: AI provides knowledge, but experts deliver wisdom.

In my latest article, I explore:
• How expert knowledge has evolved in the age of AI
• Why companies continue to invest in expertise
• How to verify AI outputs safely
• The future role of regulatory affairs experts in MedTech

Read the full article here: https://hubs.ly/Q03NCNjB0

Do you think AI is replacing experts, or making them even more valuable?

10/10/2025

Happy Thanksgiving, Canada! 🍁

This Thanksgiving, gratitude means having enough; enough love to share, enough time to pause, and enough hope to carry us forward.

Wishing you and yours a day filled with warmth, connection, and joy. 🦃✨

10/08/2025

Egypt Regulatory Update: Simplified Registration Pathways for Medical Devices

Did you know it’s now easier and faster to register medical devices in Egypt? 🇪🇬

On June 25, 2025, the Egyptian Drug Authority (EDA) announced new measures to simplify medical device registration, aligning local requirements with the European regulatory framework.

These are the key updates and accepted documentation routes:

ISO 13485:2016 certificate – If valid for the actual manufacturing site and showing its name and address, this may be sufficient.

CE certificate under MDR – Accepted if current, valid, and issued by a recognized notified body.

GMP certificate – May substitute ISO 13485 if it explicitly covers the manufacturing site. Companies must also provide a trade certificate from a reference country and a valid CE certificate.

No ISO 13485 or GMP – In this case, both the legal and manufacturing sites must be covered by a trade certificate and CE certificate.

MDD certificates – Still accepted if accompanied by a CE extension letter and a formal self-declaration confirming compliance.

EDA highlights the importance of verifying that all certificates cover the actual production site. This can be validated through the certificate itself, a confirmation letter from the issuing authority, or direct verification by EDA.

These updates provide greater clarity, reduce administrative burden, and bring Egypt’s system closer to international standards — a positive step for global manufacturers seeking faster market access.

At Arazy Group, we help manufacturers navigate evolving regulatory frameworks, ensuring compliance and accelerating market entry across the Middle East and North Africa.

📽️ Watch the full update: https://hubs.ly/Q03MRSw50
📙 Access more regulatory insights: https://hubs.ly/Q03MRShd0

About Arazy Group

Led by Benjamin Arazy, a global expert in MedTech regulatory affairs with over 30 years of experience, Arazy Group pioneered digital regulatory management solutions for the MedTech industry. Through our platforms LICENSALE® and REGISLATE®, we support manufacturers in over 140 countries to achieve faster, compliant market access.

10/07/2025

Don’t Build a Regulatory Department. Build Momentum.

In early-stage MedTech, every dollar must work twice as hard, and none should be tied to payroll when results depend on precision, not permanence.

Hiring a full-time Regulatory Affairs professional too early often drains budgets and slows progress. Instead, invest in an experienced consultant who can shape your strategy, prepare a flawless submission, and keep you audit-ready without long-term overhead.

With $100K, you can either fund a salary or fund your pathway to FDA clearance. CEOs who understand this difference reach the market faster and with fewer setbacks.

Regulatory excellence isn’t about headcount. It’s about velocity, focus, and smart leadership.

At Arazy Group, this insight is built on over 30 years of global experience supporting thousands of early-stage and startup MedTech companies. We’ve seen how strategic regulatory planning turns innovation into market success, efficiently and confidently.

Read the full article here: https://hubs.ly/Q03MDcYz0
Watch more insights on our YouTube channel: https://hubs.ly/Q03MDmtF0

We often meet early-stage MedTech companies facing a common dilemma: navigating complex regulatory landscapes with limited budgets. It is understandable; every dollar goes toward R&D, product development, and market entry.

10/06/2025

Taiwan Updates Medical Device Standards Framework with Comprehensive Revision

On July 22, 2025, Taiwan’s Food and Drug Administration (TFDA) published the 114-Year Approved Medical Device Standards List and a historical list of previously approved standards under its medical device framework.

The new list includes 1,357 recognized standards, featuring 79 newly added, 9 withdrawn, and 185 revised standards among the continuing 1,287 recognized entries. In parallel, TFDA released a “Historical Withdrawn Standards List” containing 264 outdated standards, encouraging manufacturers to promptly transition to the new or alternative recognized ones.

This update marks a significant regulatory realignment—streamlining technical consistency and ensuring harmonization with international standards. Manufacturers operating in Taiwan should review their conformity documentation, testing methods, and quality systems to maintain compliance with the latest recognized standards.

Taiwan’s proactive approach underscores a broader trend across Asia toward regulatory modernization, digital alignment, and strengthened post-market oversight.

Stay updated with regulatory developments worldwide.
Subscribe to our weekly newsletter: https://hubs.ly/Q03MqHrn0

For more details, visit the TFDA Medical Device Regulation section on the agency’s official website: https://hubs.ly/Q03MqHpC0

10/03/2025

Serbia Advances Full Digitalization of Medical Device Registration via ALIMS ePortal

On June 30, 2025, Serbia’s Medicines and Medical Devices Agency (ALIMS) released updated guidance for medical device registration (Revision 5) and renewal (Revision 3), marking a decisive step toward fully electronic regulatory submissions through the ALIMS ePortal.

The new instructions set a minimum 30-day submission deadline before expiry for renewals, restrict bundled applications to devices sharing the same class, category, and certificate, and require fee payments within 20 days of initiation.

To strengthen compliance and accountability, applicants must appoint qualified full-time personnel responsible for documentation and vigilance. Required submissions include application forms, Declarations of Conformity, EC Certificates, packaging and labeling in both English and Serbian, instructions for use, and manufacturer authorizations.

For Class I and certain IVD devices originating from non-EU or non-MRA countries, additional evidence such as ISO 13485 certification or EU market proof (e.g., Free Sale Certificates) is now mandatory.

Both revised instructions also define refund conditions in case of withdrawal, reinforcing Serbia’s move toward transparent, traceable, and fully digital regulatory workflows aligned with EU principles.

This modernization reflects ALIMS’s commitment to regulatory efficiency, digital transformation, and harmonized market oversight; key priorities for agencies and manufacturers operating in an increasingly connected MedTech ecosystem.

Stay informed on global regulatory changes shaping the MedTech industry.
👉 Subscribe to our weekly newsletter:https://hubs.ly/Q03M8MbK0

For the full publication, visit: https://hubs.ly/Q03M8L9l0

10/02/2025

Missed our September RegTalk? 👀

Catch up on key MedTech updates from South Africa, Singapore, Pakistan, China, Egypt & Canada:
💡 AI/ML device guidance | Digital registration systems | Self-inspection rules | Streamlined procedures | eSAT pilot

🎥 Watch the full session here: https://hubs.ly/Q03L_7Np0

For more information and to explore our services, visit us here 👉 https://hubs.ly/Q03L_4Qy0