Noticias y novedades
Is the TGA Sponsor Responsible for the Quality or Safety of Your Products?
No, it’s essential to understand that in Australia, the role and responsibilities of a sponsor are distinct from those of a manufacturer. A sponsor registered with the Therapeutic Goods Administration (TGA) ensures the product complies with Australian regulations and [...]
Looking for an FDA Agent? 5 Key Factors to Consider
If you’re selecting an FDA Agent for the U.S. market, certain factors can make all the difference. Here are five essential aspects to ensure you’re making a smart, strategic choice: Expertise in FDA Regulations A strong FDA Agent has [...]
What is the IFU and why is it crucial for medical devices?
The Instructions for Use (IFU) is essential for every medical device. Here's why it's so important: 1. User safety: It provides detailed instructions to ensure safe use, reducing the risk of errors. 2. Intended use: It specifies how and [...]
Discover how to register your medical devices in Europe: an essential guide for manufacturers outside the EU!
Are you a manufacturer outside the EU and wondering how the medical device registration process works in Europe? Here’s an essential overview to guide you through the regulatory system! Step 1: Actor Registration The first step is providing key information [...]
Clinical Research in Medical Devices: What Role Does the Manufacturer Play?
Clinical research is fundamental to ensuring the safety and effectiveness of medical devices. But what are the key responsibilities of the manufacturer in this process? Here’s what you need to know: Study Design: The manufacturer must ensure that the [...]
Exciting news! We’re heading to CMEF, the International Medical Device Fair in Shenzhen!
Join us from October 12 to 15, 2024, at the Shenzhen World Exhibition and Convention Center. Our team is excited to meet industry professionals and discuss how we can support your regulatory needs in the medical device sector. 📌 [...]
Importers or Distributors: Who is Responsible for Medical Device Compliance?
Understanding the responsibilities of importers and distributors is fundamental to ensuring that medical devices comply with regulations and safely reach markets. Here’s a clear breakdown: Importer vs. Distributor: What’s the Regulatory Difference? Importer: This is the person or company [...]
Discover the 6 Steps to Successfully Obtain CE Certification
If you’re developing a medical or in vitro diagnostic device, obtaining the CE mark is essential to enter the European market. Here are the key steps: Classification: Determine the classification of your device (I, IIa, IIb, III for medical [...]
Exciting Update: Istituto Superiore di Sanità Now Accredited for IVDR!
A new key player has been designated for the In Vitro Diagnostic Regulation (IVDR)! The Istituto Superiore di Sanità (NB 0373), based in Italy, has been recently accredited as a notified body. With this addition, the total number of [...]
