Blog

Updated UK MHRA guidance clarifies medical device importer requirements for Northern Ireland

Medical device and IVD registrations and new standards are summarized in the two reports, demonstrating a busy year for regulators in the fight to contain COVID-19.

The new IO is designed to extend the provisions of the first, containing provisions for the importation and sale of medical devices related to COVID-19, without requiring further action from stakeholders.

Recommendations for preparing for Eudamed compliance ahead of MDR and IVDR dates of application

The Medicines and Medical Devices Act 2021 received royal assent after a year-long legislative process that saw it updated with recommendations to protect public safety.

Indian health ministry, CDSCO propose additional options for demonstrating medical device conformance

The British regulatory agency added a section to its general guidance on medical device and IVD registration, providing information on grace periods, representative appointments, and required declarations.

Under current regulatory reforms, some clinical decision support software (CDSS) meeting the definition of a medical device will be excluded or exempted from regulation by Australia’s Therapeutic Goods Administration (TGA). A new guidance document assists with applying the exemption criteria and explains subsequent steps.

The latest version of the document published by the SFDA details use of the e-Product Classification System (PCS) and notes several product types re-classified from drugs to medical devices.

Eudamed UDI and registration guidelines for legacy medical devices and IVDs

The Norwegian Medicines Agency (NoMA) has confirmed that, in order to be marketed inside the country, medical device labeling and instructions for use must be printed in the Norwegian language.

Emergo by UL's HFR&D team raising awareness of human factors among students

New Coordinated Assessment Pathway to expedite medical device clinical trial reviews in the UK

Kevin Fu will serve for one year as acting director, a new role created to address growing concerns about cyber threats in the healthcare sector.

Key design tips and considerations for engaging in design-related projects