Noticias y novedades
Post-Market Surveillance (PMS): A Key Pillar for Compliance and Innovation in the Medical Device Industry
In the rapidly evolving field of medical devices, compliance with Post-Market Surveillance (PMS) requirements has become a cornerstone of safety, innovation, and market competitiveness. However, a recent report by the Health and Youth Care Inspectorate (IGJ) paints a concerning picture: [...]
Is the FSC valid indefinitely, or does it have an expiration date?
If you’re a medical device manufacturer, understanding the validity of your FSC (Free Sales Certificate) is crucial for maintaining market access and ensuring regulatory compliance. The FSC doesn't have a specific expiration date. Instead, its validity depends on the regulations [...]
How to Obtain CDSCO Approval for Medical Devices
Obtaining CDSCO (Central Drugs Standard Control Organization) approval in India is a crucial step for entering this growing market. The process starts with submitting a detailed application that includes the Intended Use of your product and provides evidence of safety [...]
When Should You Involve a CRO in Medical Device Development?
The optimal time to engage a Contract Research Organization (CRO) in your medical device’s development is as early as possible, ideally during the initial planning phase of your clinical study. Involving a CRO from the outset ensures a study [...]
New Revision of European Medical Device Regulations: Towards Greater Transparency and Safer Access for All
In response to current challenges regarding the accessibility and safety of medical devices, the European Parliament approved a landmark resolution on October 23, 2024, to revise the regulatory framework for these products across the European Union. This urgent update [...]
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 [...]
