Understanding Europe’s In Vitro Diagnostic Medical Devices Regulation
Learn more about EU In Vitro Diagnostic Medical Device Regulations.
Amendments Proposed to the Medical Device Regulatory System in Israel
The Medical Device Division, AMAR, of the Ministry of Health in Israel has announced proposed amendments to the medical device regulatory system (August 14, 2023). The changes are intended to reduce the registration and import timelines.
Early Communication with the FDA
Learn more about tips and other information to help you feel comfortable when corresponding with the FDA.
Update on the Switzerland Swissmedic Medical Device Database
With the European medical device and IVD regulations Date of Application and the expiration of the agreement on mutual recognition of conformity assessments (MRA) between the EU and Switzerland, Switzerland has been operating as a “third country.”
European Association of Notified Bodies Releases Report on MDR Transition
The European Association of Medical Devices Notified Bodies, Team-NB, released a white paper on August 10, 2023, called “New MDR Transition Timelines and Notified Body Capacity” (TEAM-NB Position Paper).
Malaysia Medical Device Regulator MDA Revises Consultancy Services
The Malaysia Medical Device Authority (MDA) updated its consultancy services (August 2, 2023). Initially offered in July 2019, as in-person consultation services (quoted as RM 600 per hour), the MDA’s services have now been relaunched.
EU Update: The Activities and Accomplishments of CORE–MD
The Coordinating Research and Evidence for Medical Devices organization, better known as CORE-MD, is an EU collaboration of 22 entities that strive to improve clinical evidence methodologies on high-risk implantable medical devices.
China Update: Opinions to Further Improve Classification Management of Medical Devices and More
China’s regulators have announced new guidelines, consultation of draft opinions on further strengthening supervision of entrusted production and more.
Draft Medical Device Post-Market Surveillance Requirements Published for the UK
Statutory Instrument will align UK PMS requirements with those of the European Medical Devices Regulation (MDR).
What is the Applicable European Product Legislation?
This series features European (EU) medical device legislation.