Singapore The Health Sciences Authority (HSA) regulates health products to ensure that they meet the required standards of quality,...

“FDA intends to harmonize and modernize the Quality System regulation for medical devices. The revisions will supplant the existing...

Canada: Medical device fees increased by 2% from 1 April 2018 Canada: New Digital Health Review Division to be established Canada:...

International - Press Release of the PIC/S Committee Meeting in Geneva (Switzerland), May-2018 Australia - Australian Regulatory...

International - WHO Drug Information, Volume 31, No. 4 International - EDQM Press Release: The Ph. Eur. Revised its General Chapters on...

Canada: Introduction of reduced MDSAP audit times Canada: Regulations affecting dental x-ray equipment have been amended Canada: Proposed...

Canada: Comments solicited on proposed new fees for medical devices and pharmaceuticals USA: Key provisions of the ‘FDA Reauthorization...

US: Mepergan Fortis Capsules; Final Decision on Proposal to Refuse Approval of Supplemental New Drug Application; Availability of Final...

US: Minimal Manipulation and Homologous Use Products US: Manufacturers Sharing Patient-Specific Information from Medical Devices with...

US: FDA and Beyond – REMS 1.16 Subheading Instructions for eCTD M1 v2.3 (DTD 3.3) US: Manual of Policies and Procedures(MAPP) 6021.1...

Canada: Medical device fees increased by 2% from 1 April 2017 Canada: Static magnets may not be promoted with medical claims Canada:...

Australia: Guidelines on Compounded Medicines and Good Manufacturing Practice (GMP) Australia: Guidelines on Code of Practice for...

The US Food and Drug Administration (FDA) still plans to increase oversight of laboratory-developed tests (LDTs), despite an announcement...

The original guidance from the US Food and Drug Administration (FDA) on the biological evaluation of medical devices was The Blue Book...

Canada: Non-eCTD electronic-only format to be used for medical device regulatory activities Canada: Scientific and clinical content of...

Australia: Strengthening Monitoring of Medicines in Australia Canada: Notice: Guidance Document - Fees for the Right to Sell Drugs...

The FDA recently released two draft guidance documents: "Deciding When to Submit a 510(k) for a Change to an Existing Device,” which...