Home » Topics » Medical Devices » Regulatory Affairs

February 20, 2020
Malaysia Issues Guidance on Refurbished Medical Devices
The devices may have had components or sub-assemblies replaced that aren’t suitable for reuse.
February 18, 2020
IMDRF Cancels Singapore Meetings Because of COVID-19 Outbreak
The number of confirmed cases of COVID-19 infection in Singapore was 77 as of February 17.
February 14, 2020
UK Introduces New Legislation to Overhaul Medical Device Authority
The UK government has introduced a bill that would update the nation’s regulatory framework for medical devices by the end of the post-Brexit transition period which ends Dec. 31, 2020.

February 14, 2020
FDA Revises Guidance on 510(k) Submissions for Atherectomy Devices
February 14, 2020
FDA Issues Update on Pilot Accreditation Scheme for Conformity Assessments
February 14, 2020
Coronavirus Outbreak Threatens to Disrupt Device Supply Chain
February 14, 2020
Post-Brexit UK to Overhaul Medical Device Authority
February 14, 2020
FDA Outlines New Accreditation Scheme for Conformity Assessments

February 14, 2020
Coronavirus Outbreak Threatens Supply Chain, Says Former FDA Commissioner
February 13, 2020
FDA Revises Guidance on 510(k) Submissions for Atherectomy Device
February 12, 2020
FDA Flags Risks of Multi-Patient Use Arthroscopy Pump Tubing Sets
February 10, 2020
Proposed Bill Would Allow FDA to Destroy Counterfeit Products
February 7, 2020
FDA Schedules Workshop on Virtual And Augmented Reality in Medicine

Products

Events