What are the opening hours?

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

Arazy Group Consultants Inc., West Georgia, Vancouver, BC (2025)

09/12/2025

Here’s what’s shaping the MedTech regulatory landscape this week:

🔹 Singapore introduced new requirements to strengthen oversight of medical devices, streamlining approvals while ensuring patient safety.

🔹 India advanced initiatives to expand compliance coverage, emphasizing the importance of timely registrations and alignment with evolving standards.

🔹 Europe – Arazy Group’s Regulatory Services continue supporting manufacturers navigating MDR challenges, ensuring efficient market access across the region.
👉 Learn more: https://hubs.ly/Q03Jbrwd0

📌 For daily, weekly, and monthly updates from around the world, visit: https://hubs.ly/Q03Jbqn-0

Stay informed. Stay compliant. Stay competitive.

09/11/2025

Singapore Regulatory Update: SaMD & CDSS Guidelines 🖥️

On July 21, 2025, Singapore’s Health Sciences Authority (HSA) released Revision 2 of guideline GL-07, clarifying the risk classification of Software as a Medical Device (SaMD) and the qualification of Clinical Decision Support Software (CDSS).

Key Takeaways:
Risk-based framework: SaMD classified as Class A, B, or C depending on patient condition and significance of information provided.

Examples: migraine risk prediction, sleep apnoea monitoring, cardiac triage, diabetic retinopathy diagnosis.

CDSS scope: software used for diagnosis, prevention, or treatment is regulated; tools limited to displaying information or guidelines are not.

Why it matters:
This update offers clarity for digital health and AI-driven solutions, reinforcing the need for early alignment with HSA requirements to ensure compliance and smooth market access.

With over 30 years of expertise, Arazy Group helps MedTech companies adapt quickly to evolving regulations worldwide.

🌐 Explore global updates: https://hubs.ly/Q03J0q390
📘 Read HSA’s guideline: https://hubs.ly/Q03J0q8Q0

09/10/2025

🌍 Your one partner for European Regulatory Representation

Entering new European markets can feel complex. Many MedTech companies start by working with multiple providers for each country, seemingly logical at first, until extra admin, inconsistent processes, and higher costs slow everything down.

With one trusted partner across the EU, UK, and Switzerland, you get a single team managing your Authorized Representative and PRRC needs, seamlessly powered by LICENSALE®, our global registration management system. The benefits?

Consistency in compliance across all European markets

Less administrative burden so your team can focus on growth

A faster path to market for your devices

Companies that centralize this process save time and energy, letting them focus on what truly matters: expanding in Europe efficiently and confidently.

🔗 Learn more: European Regulatory Representation

09/08/2025

India Regulatory Update: Key Clarifications to Medical Devices Rules 🇮🇳

In April and July 2025, India’s Central Drugs Standard Control Organization (CDSCO) released two FAQ addenda to the Medical Devices Rules, 2017, addressing some of the most common queries from manufacturers, importers, and registration holders.

These clarifications bring more certainty to compliance while aligning India with global standards. Here are the highlights:

🔹 Biocompatibility Testing – Required only for devices with body contact. Testing must follow ISO 10993 standards. Existing data can be reused if the material, supplier, and process remain identical, backed by justification and a biological risk assessment. Any change requires revalidation, and complaints/adverse events trigger “for-cause” testing.

🔹 Parametric Release of Sterilized Devices – Allowed without batch-wise testing when the sterilization process is validated and routinely revalidated. Accepted standards include EO (ISO 11135), Gamma (ISO 11137), and Steam (ISO 17665). This offers flexibility while ensuring strong quality control.

For MedTech companies, these updates clarify gray areas and set clearer pathways for compliance. At Arazy Group, we help manufacturers and importers navigate these evolving requirements, minimizing regulatory risks and strengthening market access strategies.

📽️ Watch the full update here: https://hubs.ly/Q03HmzsW0
📙 Access more regulatory insights: https://hubs.ly/Q03HmQq90

09/05/2025

Keep up with MedTech Regulatory Updates – Anywhere in the World!

Every month, we bring you the latest regulatory updates from over 140 countries, covering every continent. Our goal? To make sure you’re always informed and ready to navigate the global MedTech landscape.

Plus, you get exclusive insights from Imane Jemal, our Medical & IVD Device Regulatory Affairs expert, who shares practical strategies, expert analysis, and tips from thousands of successful registrations.

It’s more than a newsletter, it’s your monthly guide to stay ahead in compliance and market access.

📩 Subscribe today and start receiving updates straight to your inbox: https://hubs.ly/Q03Hbq2w0

09/04/2025

Breaking Barriers in MedTech: New Markets, Real Results

One of the most rewarding parts of what we do at Arazy Group is seeing our partners’ products cross borders and reach patients who truly need them.

Recently, we celebrated new registration successes across the Middle East, a reminder that behind every approval there’s a story of teamwork, strategy, and persistence.

Expanding into new markets can feel overwhelming, but with the right guidance, doors open. That’s why we created our MARI Score: a simple yet powerful tool to help MedTech companies understand their readiness for global growth.

If you’re wondering what’s next for your product, we’d love to explore that journey with you. Because at the end of the day, it’s not just about regulations: it’s about making sure innovation finds its way to the people who need it most.

🔗 Learn more: https://hubs.ly/Q03H00Fw0

09/04/2025

Breaking Barriers in MedTech: New Markets, Real Results

One of the most rewarding parts of what we do at Arazy Group is seeing our partners’ products cross borders and reach patients who truly need them.

Recently, we celebrated new registration successes across the Middle East, a reminder that behind every approval there’s a story of teamwork, strategy, and persistence.

Expanding into new markets can feel overwhelming, but with the right guidance, doors open. That’s why we created our MARI Score: a simple yet powerful tool to help MedTech companies understand their readiness for global growth.

If you’re wondering what’s next for your product, we’d love to explore that journey with you. Because at the end of the day, it’s not just about regulations: it’s about making sure innovation finds its way to the people who need it most.

🔗 Learn more: https://hubs.ly/Q03G_T340

09/03/2025

Regulatory Representation should empower your growth, not create conflicts of interest.

At Arazy Group, we’ve learned from years of experience that MedTech companies need more than just compliance: they need independent partners who safeguard their interests while helping them expand globally.

That’s why our Authorized Representative (AR) and License Holder (LH) Services are designed to give you:
✔️ Unbiased oversight – because your compliance should never be compromised
✔️ Distributor flexibility – so you choose what’s best for your market
✔️ Secure IP protection – your innovations remain yours, always

🌍 Your market. Your strategy. Your control. Backed by our experience.

👉 Learn how we can support your journey: https://hubs.ly/Q03GP3Vt0

09/02/2025

🇿🇦 South Africa Update: Renewals are no longer just a formality they’re a test of preparation, timing, and compliance

On June 11, 2025, SAHPRA announced new instructions for the Medical Device Establishment Licence Renewal Process.

If you operate in South Africa as a manufacturer, importer, distributor, or wholesaler, here’s what you need to know:
✔️ Renewals must be submitted 90 days before licence expiry
✔️ Applications are now electronic only
✔️ Expect 6–8 weeks processing with only two chances to fix deficiencies
✔️ Key docs: ISO 13485:2016 certificate, GMDN codes, quality manual, and proof of fees

This update is a reminder: regulatory compliance isn’t just about paperwork, it’s about protecting your market access and ensuring business continuity.

With 30+ years of global regulatory expertise, Arazy Group supports MedTech companies in adapting to changes like these and achieving timely approvals worldwide.

🌐 Explore the latest regulatory updates and learn how Arazy Group can support you
https://hubs.ly/Q03Gy2K-0

📗 Read the official SAHPRA communication:
https://hubs.ly/Q03Gy4J60

08/29/2025

Simplify Your MedTech Registrations. Without Losing Control

If you’ve ever tried to register a medical device in multiple countries, you know how complex the process can get: different regulations, changing requirements, and endless tracking spreadsheets. It can feel like compliance is slowing down your innovation.

That’s why we created LICENSALE®, a Regulatory Information and Registration Management Software (RIMS) built from 30 years of real-world experience helping MedTech companies succeed globally.

With LICENSALE®, regulatory teams can:
✔ Manage and centralize registrations in 140+ countries
✔ Monitor real-time progress with clear dashboards
✔ Collaborate seamlessly with experts worldwide
✔ Plan market access strategies and safeguard license ownership

Whether your next step is the EU, US, UK, or global markets, LICENSALE® gives you the visibility, structure, and expert support you need, so compliance becomes a growth enabler, not a roadblock.

👉 Ready to streamline your regulatory pathway and expand with confidence?
Let’s talk: https://hubs.ly/Q03GgwF_0

08/28/2025

Missed our August RegTalk? The recording is now available.

On August 26, Arazy Group hosted its monthly RegTalk, where we explored the latest regulatory developments shaping MedTech market access across six important regions: Sri Lanka, India, South Africa, Malaysia, Thailand, and China.

During this session, our experts reviewed:

1️⃣ The new guidance issued in Sri Lanka for medical device approvals

2️⃣ Regulatory changes in India that will impact registration pathways

3️⃣ Updates in South Africa on compliance procedures and timelines

4️⃣ Malaysia’s latest classification rules and AI-related guidance

5️⃣ Adjustments in Thailand’s framework for medical device oversight

6️⃣ China’s evolving requirements for device submissions and market strategy

If you were not able to attend live, you can still benefit from these insights by watching the full recording here: https://hubs.ly/Q03G6mX50

🔔 Stay ahead of regulatory shifts and gain the knowledge you need to ensure compliance and successful global market access.

Learn more about upcoming sessions at https://hubs.ly/Q03G6nC30

08/27/2025

Brazil Regulatory Update: UDI Implementation Steps Announced

On July 10, 2025, Brazil’s National Health Surveillance Agency (ANVISA) published a news article titled “Unique Identification of Medical Devices: Next Steps for Implementation,” referencing Circular Letter No. 2/2025.

This marks a significant milestone in Brazil’s regulatory framework, as the Unique Device Identification (UDI) system is now entering into effect.

The rollout will be implemented in stages:

🔹Class IV (highest-risk) devices – such as pacemakers and stents – will require UDI labeling starting July 10, 2025.

🔹Other device classes (III to I) will follow, with implementation deadlines spaced between six months to one year.

🔹While companies can already upload device data, it will only become mandatory once a Normative Instruction is issued – expected around September 2025.

🔹Once effective, manufacturers and distributors of Class IV devices must upload product data into SIUD, Brazil’s official UDI database.

This staged approach is intended to strengthen traceability, patient safety, and market transparency. However, it also introduces new compliance requirements that companies must address proactively to avoid delays or disruptions in market access.

At Arazy Group, we guide global MedTech manufacturers through complex regulatory transitions like UDI implementation, ensuring a smooth adaptation to local requirements.

📽️ Watch the full update here: https://hubs.ly/Q03FTM4z0
📙Access more regulatory insights: https://hubs.ly/Q03FTFYj0

Arazy Group Consultants Inc.

09/12/2025

09/11/2025

09/10/2025

09/08/2025

09/05/2025

09/04/2025

09/04/2025

09/03/2025

09/02/2025

08/29/2025

08/28/2025

08/27/2025

Address

Opening Hours

Telephone

Website

Alerts

Contact The Practice

Shortcuts

Share

Category

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