News and Updates
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. What Is the Free Sales Certificate (FSC)? The FSC is an essential document that [...]
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 [...]
Thank You for Making MEDICA 2024 an Unforgettable Experience
MEDICA 2024 has been a pivotal event for CMC Medical Devices, and we want to extend our heartfelt thanks to everyone who visited our stand and to those who graciously welcomed us at theirs. This year has been particularly [...]
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 design [...]
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 to [...]
Is the TGA Sponsor Responsible for the Quality or Safety of Your Products?
What is a TGA Sponsor? A TGA sponsor is an individual or company registered with the Therapeutic Goods Administration responsible for ensuring that a product complies with Australian regulatory requirements. The sponsor acts as the official point of contact [...]
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?
When it comes to medical devices, ensuring safety, compliance, and correct usage is crucial. One key document that supports these aspects is the Instructions for Use (IFU). But what is an IFU for medical devices, and why is it [...]
