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Testing • Inspection • Certification

04/11/2026

Bringing a wireless medical device to market involves more than traditional EMC testing.

Join James Cunningham for a live webinar exploring FCC certification requirements, approved radio modules, SAR testing, wireless coexistence methodologies, and RF risk assessment strategies for modern medical devices.

Learn how to proactively address compliance challenges while supporting successful market access across global regions.

📅 November 10, 2026
🕑 2:00 PM EST

🔗 Register today: https://www.nemko.com/rf-compliance-for-medical-devices-webinar-2026

04/11/2026

🌍 ASK A NEMKO EXPERT | GLOBAL MARKET ACCESS

📦 Could the wrong HS Code delay your product certification or hold up your shipment at customs?

Most manufacturers associate HS Codes with customs duties. But did you know tariff classifications can also affect mandatory product certification requirements in certain countries?

🇲🇽 Mexico is a timely example!

Recent amendments to Mexico's Annex 2.4.1 clarify which tariff classifications are subject to certain NOM compliance requirements at importation, including telecommunications equipment.

🤔 This week's Ask a Nemko Expert question:
Can an incorrect HS Code affect product certification requirements and delay customs clearance?

Our Nemko Global Market Access expert explains why HS Codes matter beyond customs duties and what manufacturers should consider before entering international markets.

🔎 Explore both articles:
💡 Ask a Nemko Expert – HS Codes & Product Certification:
https://www.nemko.com/ask-a-nemko-expert-compliance-questions-and-answers

Mexico Regulatory Update – Telecom Products Subject to Certification:
https://www.nemko.com/blog/clarification-of-telecom-product-types-subject-to-certification-in-mexico

💬 Have a regulatory compliance question of your own? Submit it to our Nemko experts!
https://www.nemko.com/ask-compliance-questions-get-expert-answers-from-nemko

03/11/2026

🚨 Taiwan Expands Cybersecurity Requirements — Is Your Product Ready?

Taiwan's Bureau of Standards, Metrology and Inspection (BSMI) recently announced expanded cybersecurity requirements for certain connected IT and audiovisual products, including networking equipment, cameras, and displays.

📅 Key Compliance Date: July 1, 2028

Updated cybersecurity and inspection requirements become mandatory for additional affected product categories. Manufacturers should start evaluating their compliance strategies now to prepare for the transition.

🌎 And Taiwan is just one example of how cybersecurity regulations are evolving worldwide!

From the EU Cyber Resilience Act (CRA) and RED cybersecurity requirements to FDA medical device cybersecurity expectations, manufacturers face an increasingly complex global regulatory landscape.

Are you prepared for what's changing in 2027 and beyond?

Join Nemko at our upcoming Compliance Without Complexity events to connect with our experts and explore the latest developments in:
🔐 Cybersecurity & Emerging Regulatory Requirements
⚡ Product Safety Standards & Certification
📡 EMC & Wireless Compliance
🌍 Global Market Access & International Regulatory Updates

📍 IRVINE, CA | December 8, 2026
3:00 PM – 7:00 PM
📍 AUSTIN / ROUND ROCK, TX | December 9, 2026
12:00 PM – 4:00 PM

💡 Stay informed. Plan ahead. Simplify compliance.
🤝 Join us for expert insights, networking, and discussions on the evolving regulatory landscape.

🔗 Irvine Registration: https://www.nemko.com/events/compliance-without-complexity-irvine-ca
🔗 Austin: https://www.nemko.com/events/compliance-without-complexity-austin-tx

Nemko — Compliance Without Complexity.

03/11/2026

A must-read update from Nemko's Global Market Access team:

Sri Lanka's regulatory landscape continues to evolve, and staying informed is key to maintaining market access. Our latest updated blog post provides fresh insights into compliance requirements in Sri Lanka, helping manufacturers better understand current expectations and navigate regulatory changes with confidence.

Key considerations include:

• Recent regulatory developments and updates
• Market access requirements for medical and electrical products
• Documentation and approval considerations
• Strategies for maintaining ongoing compliance

Whether you're entering the Sri Lankan market for the first time or managing existing certifications, this updated resource offers practical guidance to support your compliance efforts.

Read the updated article: https://www.nemko.com/blog/sri-lanka-trcsl-equipment-clearance-system-becomes-mandatory-for-type-approval-and-device-clearance-applications

02/11/2026

🚨 Tomorrow!

Don't miss our webinar: Cybersecurity for Medical Devices: FDA & EU MDR Expectations

We'll cover:
🔹 FDA cybersecurity guidance
🔹 Key cybersecurity standards
🔹 SBOM management
🔹 Vulnerability monitoring
🔹 Pe*******on testing and assessments
🔹 Post-market compliance strategies

Whether you're preparing a new submission or updating existing cybersecurity processes, you'll leave with practical insights you can apply right away.

📅 November 3, 2026
🕑 2:00 PM EST
💻 Live Webinar
🎙️ Presenter: Bryan Heenan, Cyber Security Manager

🔗 Register now: https://www.nemko.com/cybersecurity-for-medical-devices-webinar-2026

29/10/2026

Wireless medical devices face growing RF compliance challenges as technologies like 5G, RFID, NFC, wireless charging, and MRI environments become increasingly common.

Join James Cunningham on November 10 at 2:00 PM EST to learn how manufacturers can navigate FCC certification requirements, wireless coexistence testing, FDA considerations, and global market access requirements for wireless medical devices.

Gain practical insights to help reduce regulatory risks and avoid costly delays throughout product development.

📅 November 10, 2026
🕑 2:00 PM EST

🔗 Register today: https://www.nemko.com/rf-compliance-for-medical-devices-webinar-2026

28/10/2026

📍 Nemko is at MD&M West!

Kim Karpp is on site connecting with the medical device community, meeting with industry professionals, and taking in everything the show has to offer.

If you’re attending MD&M West, be sure to say hello to Kim and connect with Nemko!

28/10/2026

Who is responsible for CRA compliance: system integrators or original manufacturers?

This week's Ask a Nemko Expert, Pepijn van der Laan, Global Technical Director of Nemko Digital, explains why the answer is: it depends.

If you market a product under your own name or significantly modify it, you may assume CRA responsibilities. Simply integrating existing products may not trigger the same obligations.

And remember: compliant components don't automatically make the final solution compliant.

👉 Read the full answer:
https://www.nemko.com/ask-a-nemko-expert-compliance-questions-and-answers

💬 Submit your own compliance question:
https://www.nemko.com/ask-compliance-questions-get-expert-answers-from-nemko

28/10/2026

Are your cybersecurity processes ready for FDA and EU MDR scrutiny?

From risk assessments and threat modeling to vulnerability management and pe*******on testing, manufacturers face increasing cybersecurity expectations.

Join Bryan Heenan, Cyber Security Manager, for a practical discussion on strengthening compliance readiness and supporting successful regulatory submissions.

📅 November 3, 2026
🕑 2:00 PM EST
💻 Live Webinar

🔗 Reserve your spot: https://www.nemko.com/cybersecurity-for-medical-devices-webinar-2026

27/10/2026

🚨 Last Chance to Register! 🚨

Tomorrow's webinar will cover the latest updates and changes to the EU AI Act and what they mean for your organization.

As AI regulations continue to evolve, companies developing, deploying, importing, or distributing AI-enabled products need to understand their compliance responsibilities and upcoming requirements.

Join Nemko's experts to learn about:

✅ Key requirements for providers, deployers, importers, and distributors
✅ AI risk classifications and compliance obligations
✅ Important implementation timelines and milestones
✅ Impact on AI-enabled products and systems
✅ Practical steps to prepare for compliance

📅 Tomorrow, October 28, 2026
🕚 11:00 AM EST
💻 Live Webinar

🎤 Presented by Pepijn van der Laan, Global Technical Director, Nemko Digital

🔗 Reserve your spot today: https://www.nemko.com/eu-ai-act-updates-webinar-2026

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