![A Guide to Navigating Regulatory Compliance for Medical Devices](https://www.regdesk.co/wp-content/uploads/2024/04/HSA-on-software-medical-devices-specific-aspects2.jpg)
Jun 14, 2024
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...
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![Medical Device Regulations in the United States](https://www.regdesk.co/wp-content/uploads/2024/06/01-medical-device-regulations-in-the-united-states.jpg)
Jun 14, 2024
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...
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![Leveraging RIMS Platforms for Global Market Access](https://www.regdesk.co/wp-content/uploads/2024/05/01-Leveraging-RIMS-for-Global-Market-Access.png)
May 29, 2024
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...
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![Medsafe Guidelines on the Regulation of Therapeutic Products: Overview](https://www.regdesk.co/wp-content/uploads/2024/07/Medsafe-on-regulations-overview.jpg)
Jul 12, 2024
GRTPNZ
The article highlights the key points related to the regulatory framework for healthcare products in New Zealand
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![Medsafe Guidelines on the Regulation of Therapeutic Products: Key Elements](https://www.regdesk.co/wp-content/uploads/2024/07/Medsafe-on-regulations-key-elements.jpg)
Jul 12, 2024
GRTPNZ
The new article describes in detail the key elements of the regulatory system for healthcare products.
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![Medsafe Guidelines on the Regulation of Therapeutic Products: Specific Aspects](https://www.regdesk.co/wp-content/uploads/2024/07/Medsafe-on-regulations-specific-aspects.jpg)
Jul 12, 2024
GRTPNZ
The new article provides further clarifications on certain specific aspects associated with the regulatory requirements healthcare products, including medicines and medical devices, should comply with in order to be allowed for marketing and use in New Zealand.
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![Medsafe Guidelines on the Regulation of Therapeutic Products: Categorization](https://www.regdesk.co/wp-content/uploads/2024/07/Medsafe-on-regulations-product-categories.jpg)
Jul 12, 2024
Medsafe
The new article explains the approach to be applied with respect to different categories of healthcare products based on specific criteria.
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![MHRA Notice on AI Airlock](https://www.regdesk.co/wp-content/uploads/2024/07/MHRA-on-AI-Airlock.jpg)
Jul 12, 2024
AIaMD
The article provides a general overview of the new regulatory framework for innovative AI-based healthcare products intended to be marketed and used in the UK.
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![MDCG Guidance on Conformity Assessment and Notified Bodies: Overview](https://www.regdesk.co/wp-content/uploads/2024/07/MDCG-on-CABs-and-NBs-overview-and-pre-assessment.jpg)
Jul 12, 2024
EU
The article provides a general overview of the existing legal framework for special authorized bodies undertaking special functions with respect to medical devices.
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