CMC Medical Devices

Casa
España
Málaga
CMC Medical Devices

Representante autorizado y consultoría global para productos sanitarios.

Ofrecemos servicios personalizados que permiten a los fabricantes de productos sanitarios lograr el cumplimiento normativo y el acceso al mercado de cualquier país.

21/08/2025

✨ We are at Medical Fair China 2025 – Suzhou International Expo Centre!

Our team is here to stay up to date with the latest innovations and connect with industry professionals. 🚀

As always, we are ready to support manufacturers of medical devices and IVDs with tailored regulatory solutions to ensure compliance and smooth market access worldwide. 🌍

See you around at the fair 👋

06/08/2025

🎯 Medical Fair China 2025: We’ll Be There!

From August 21 to 23, we’ll be at the Suzhou International Expo Centre for Medical Fair China 2025

📍 We’ll be there to meet you in person, understand your needs, and help you find the best regulatory solutions to navigate international markets with confidence.

👥 Our team of experts will be available to answer your questions and explore new opportunities for your business.

📩 Want to schedule a meeting with us during the fair?
Get in touch, we’ll be happy to arrange an appointment.

📍 See you soon at Medical Fair China 2025!

⸻

29/07/2025

Even if your products differ slightly, what matters is their classification under the relevant EMDN level.

🔍 But how do you determine if two devices belong to the same generic group?

📘 Under MDR, you need to check the 4th level of the EMDN (letter + 6 digits)
📘 Under IVDR, look at the 3rd level (letter + 4 digits) plus the Intended Purpose (IVP)

This distinction determines whether you can appoint separate Authorized Representatives and getting it wrong could mean non-compliance.

📩 Reach out to ensure your regulatory pathway is clear and compliant.

Dirección

Calle Horacio Lengo, 18
Málaga
29006

Teléfono

+34951214054

Página web

http://www.cmcmedicaldevices.com/

Notificaciones

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