Category: Medical Device

USA: CDRH drafts Guidance on Contact Lenses – Performance Criteria to Support 510(k)s

March 17, 2020
Medical Device

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) released new draft guidance to support firms planning to submit a 510(k) using the Safety and Performance...

FDA Bans Electrical Stimulation Devices Used for Self-injurious Behavior or Aggressive Behaviour

March 17, 2020
Medical Device

The US Food and Drug Administration (FDA) announced to ban electrical stimulation devices (ESDs) used to treat aggressive behaviour or self-injurious, denoting the third time in the agency’s history...

Medical Device Incident and Adverse Event Reporting Timelines in 6 Major Markets

March 13, 2020
Medical Device

Prior preparation is necessary for an immediate investigation of incidents once they occur. This is necessary not only because you are keen on ensuring patient safety but also as immediate action has...

TGA: Regulatory Impact Statement – Proposed Regulatory Scheme for Personalised Medical Devices, Including 3D-Printed Devices

March 5, 2020
Medical Device

Technology changes have the potential to deliver significant advantages and opportunities to Australians. Ongoing advances are both disrupting and altering the health sector, where there is rapid change...

Danish Medicines Agency Recommended New Regulation for Application for a Clinical Trial Permit for Medical Devices

March 5, 2020
Medical Device

Danish Medicines Agency recommended a new regulation on medical devices (MDR 2017/745) is effective from 26 May 2020, new rules on clinical trials. Applications for clinical trials have to be processed...

TMDA Released Guidance on the Import of Research Products to Be Used in Clinical Research

March 5, 2020
Medical Device

Turkish Medicines and Medical Devices Agency (TMMDA) issued guidance in order to determine the principles and procedures for the import of products to be used in clinical research studies conducted...