Find all the regulations related to medical devices, pharmaceutical products and wines and spirits here. Classification by medical device class and geographical area helps to simplify your search. If you are looking for more information on a specific regulation, please to contact us.
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New rules for MD between Switzerland and the EU
Europe
Medical Devices Information
Since 2002, the Mutual Recognition Agreement (MRA) between the European Union and Switzerland has facilitated bilateral exchanges, particularly for medical devices. However, due to the political impasse surrounding the institutional framework agreement, the European Commission did not renew the MRA after May 26, 2021. For European manufacturers, the Swiss Federal Council has implemented mitigating measures….
FDA Regulation of MD: A Comprehensive Guide
United States
Medical Devices Information
In the dynamic landscape of healthcare, the role of medical devices cannot be overstated. From life-saving ventilators to essential pacemakers, these devices play a pivotal role in diagnosis, treatment, and patient care. As technology continues to evolve, so does the complexity of ensuring the safety and efficacy of medical devices. This complexity is why the…
GUDID revolutionizing Medical Device Identification
United States
Medical Devices Information
The healthcare landscape is constantly evolving, and ensuring the safety and traceability of medical devices is paramount. In the United States, the Food and Drug Administration (FDA) has taken significant strides toward enhancing device identification through the Global Unique Device Identification Database (GUDID). GUDID serves as a centralized repository for crucial information about medical devices…
Saudi Arabia Implements Unique Device Identification Requirements for Medical Devices
Saudi Arabia
Medical Devices Information
As of September 1, 2023, Saudi Arabia has mandated the implementation of Unique Device Identification (UDI) requirements for Class B, C, and D medical devices within its territory. Class A devices will follow suit starting September 1, 2024, with exemptions in place for custom-made medical devices or those designated for clinical investigations. This move, initiated by…
Medical Device and IVD Registration in China: Key Considerations and Processes
China
IVD
Medical Devices Information
China’s healthcare industry offers immense opportunities for medical device manufacturers looking to enter this dynamic market. However, entering the Chinese market demands meticulous adherence to regulatory processes overseen by the National Medical Product Administration (NMPA). Understanding the intricacies of medical device and in-vitro diagnostic (IVD) registration is the key for successful market entry in China….
Implantable medical devices, the implant card
Europe
AIMD
The Regulation (EU) 2017/745 introduced an additional obligation for implantable medical devices, the implant card. It achieves two specific objectives: to increase transparency and to ensure better access to information about the IMD. IMD manufacturers will have to indicate all the required information on an implant card that will be delivered with the device. In…
Eudamed, the registration of economic actors
Europe
Medical Devices Information
Updated version 2.9 – October, 2022 The registration module of the economic actors is an electronic system which allows to register the companies as: Manufacturer, Authorized representative, Importer, System/Procedure pack producers. The registration creates a unique registration number that will allow economic operators to submit all necessary information in order to be easily identifiable throughout…
Implementation of EU Regulation 2021/2117
Europe
Wines & Spirits
8 December 2023 On this date the changes to labelling rules for wines and aromatised wines will become effective. Producers will then have to provide the list of ingredients and nutritional information for their products. For example, the new directive stipulates that producers must indicate that a wine contains sulphites if quantities exceed 10 mg/L….
European medical device regulation – 2017/745
Europe
Medical Devices Information
In order to reform legislation on medical devices, the European Commission has adopted two regulations, which have been in force since May 2021. The first, Regulation (EU) 2017/745, pertains to medical devices. The second, more specific Regulation (EU) 2017/746 targets in vitro diagnostic medical devices. The European regulation of medical devices can be confusing to…