Medical Device Regulatory Requirement

Overview of Device Regulation | FDA

https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/overview-device-regulation

Device Advice. Overview of regulations for medical devices: premarket notifications (510(k)), establishment registration, device listing, quality systems, labeling and reporting requirements.

Overview of Regulatory Requirements: Medical Devices

https://www.fda.gov/training-and-continuing-education/cdrh-learn/overview-regulatory-requirements-medical-devices-transcript

This is a requirement for all finished device manufacturers, as well as importers of medical devices. Manufacturers must also list their medical devices with the FDA at the time …

ISO - ISO 13485 — Medical devices

https://www.iso.org/iso-13485-medical-devices.html

Manage quality throughout the life cycle of a medical device with ISO 13485. ... Safety and quality are non-negotiable in the medical devices industry, that’s why we developed ISO 13485. Regulatory …

Medical devices | European Medicines Agency

https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices

The Regulations on Medical Devices (Regulation (EU) 2017/745) and on In Vitro Diagnostic Devices (Regulation (EU) 2017/746) changed the European legal …

The Role of Regulatory Affairs in the Medical Device …

https://www.northeastern.edu/graduate/blog/regulatory-affairs-in-medical-device-industry/

ISO 13485 - Regulatory Requirements on …

https://blog.sierralabs.com/iso-13485-regulatory-requirements-on-medical-devices

The Source of Regulatory Requirements. The standard clarifies that regulatory requirements are applicable laws, regulations, ordinances, and/or directives. ISO 13485 standard treats …

What Regulatory Requirements Does …

https://www.mindflowdesign.com/insights/guide-medical-device-regulatory-requirements/

Over the course of your medical device’s lifespan, you will need to remain current with all regulatory requirements. Meaning, you’ll need to comply with them at all times. Knowing …

Medical Device Regulation comes into application

https://www.ema.europa.eu/en/news/medical-device-regulation-comes-application

Regulation (EU) 2017/745 on medical devices becomes applicable in the European Union today, 26 May 2021. ... To support the implementation of the MDR, …

New UK MHRA Medical Devices Regulations Published - NAMSA

https://namsa.com/uk-mhra-medical-device-regulations-published/

On 26 June 2022, the United Kingdom’s Medical Devices and Healthcare Regulatory Authority (MHRA) published the results and conclusions from the …

Medical Device Regulatory Requirements - New Japanese …

https://www.emergobyul.com/resources/medical-device-regulatory-requirements-new-japanese-guidelines

Japan’s medical device market is one of the most robust markets in Asia, but its regulatory system can prove confusing. Before deciding to sell your device in the …