Medical Device Regulation Resources
Worldwide, medical devices are subject to strict regulations, and for good reason — they are crucial for helping health care professionals identify, treat and combat diseases. Strict rules ensure patient safety and treatment efficacy. However, compliance is...
United States
Medical devices are highly regulated in the United States. Since U.S. regulatory compliance for MedTech is stringent and continuously changing, staying up-to-date on the latest standards helps businesses avoid costly violations and improve the efficacy and safety of...
HSA
Global market access is crucial for medical device companies looking to reach new customers, enhance brand recognition worldwide and ultimately increase revenue opportunities. However, expanding operations and reaching new countries can be highly challenging for these...
Medical Devices
In today’s rapidly evolving regulatory landscape, medical device companies face increasingly complex challenges in bringing their products to market and maintaining compliance across multiple jurisdictions. The good news is that technological advancements, particularly in artificial intelligence (AI), machine learning (ML), and automation, are revolutionizing the field of regulatory affairs. These innovations are not just buzzwords; they’re powerful tools that can streamline workflows, reduce errors, and significantly accelerate time-to-market for medical devices.
European Commission
The new article describes in detail certain specific aspects to be taken into consideration by the parties involved in order to ensure the important information is duly communicated in accordance with the relevant regulatory requirements.
Great Britain
The article describes in detail the approach the UK authority intends to apply when implementing amendments to the existing legal framework.
Great Britain
The new article provides additional clarifications regarding the upcoming changes to the UK regulatory framework.
Tanzania
The article outlines the key points of the regulatory approach applied in Tanzania when it comes to medical devices intended to be marketed and used in the country.
Tanzania
The new article explains in detail the way the relevant principles and practices should be implemented in order to ensure the safety and proper performance of medical devices allowed for marketing and use in the country.
