Fees increase after years in Singapore HSA & Philippines FDA, and yearly approach increase by US
Singapore The Health Sciences Authority (HSA) regulates health products to ensure that they meet the required standards of quality,...
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ARQon
May 24, 20181 min read
US QSR Revision Plan For Harmonization To ISO 13485
“FDA intends to harmonize and modernize the Quality System regulation for medical devices. The revisions will supplant the existing...
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ARQon
May 23, 20182 min read
North America - May 2018
Canada: Medical device fees increased by 2% from 1 April 2018 Canada: New Digital Health Review Division to be established Canada:...
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ARQon
May 23, 20181 min read
Drugs - May 2018
International - Press Release of the PIC/S Committee Meeting in Geneva (Switzerland), May-2018 Australia - Australian Regulatory...
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ARQon
Feb 12, 20182 min read
Drugs - February 2018
International - WHO Drug Information, Volume 31, No. 4 International - EDQM Press Release: The Ph. Eur. Revised its General Chapters on...
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ARQon
Feb 2, 20184 min read
North America - February 2018
Canada: Introduction of reduced MDSAP audit times Canada: Regulations affecting dental x-ray equipment have been amended Canada: Proposed...
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ARQon
Jan 1, 20182 min read
North America - December 2017
Canada: Comments solicited on proposed new fees for medical devices and pharmaceuticals USA: Key provisions of the ‘FDA Reauthorization...
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ARQon
Jan 1, 20181 min read
Drugs - December 2017
US: Mepergan Fortis Capsules; Final Decision on Proposal to Refuse Approval of Supplemental New Drug Application; Availability of Final...
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ARQon
Nov 1, 20172 min read
Drugs - October 2017
US: Minimal Manipulation and Homologous Use Products US: Manufacturers Sharing Patient-Specific Information from Medical Devices with...
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ARQon
Sep 1, 20172 min read
Drugs - August 2017
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...
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ARQon
Aug 24, 20171 min read
North America - May 2017
Canada: Medical device fees increased by 2% from 1 April 2017 Canada: Static magnets may not be promoted with medical claims Canada:...
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ARQon
Aug 24, 20172 min read
Drugs - May 2017
Australia: Guidelines on Compounded Medicines and Good Manufacturing Practice (GMP) Australia: Guidelines on Code of Practice for...
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ARQon
Apr 7, 20171 min read
The need for increased US FDA oversight of laboratory-developed and other laboratory tests - April 2
The US Food and Drug Administration (FDA) still plans to increase oversight of laboratory-developed tests (LDTs), despite an announcement...
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ARQon
Apr 7, 20171 min read
US FDA guidance on the use of ISO 10993-1 for the biological evaluation of medical devices: the top
The original guidance from the US Food and Drug Administration (FDA) on the biological evaluation of medical devices was The Blue Book...
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ARQon
Apr 4, 20172 min read
North America - April 2017
Canada: Non-eCTD electronic-only format to be used for medical device regulatory activities Canada: Scientific and clinical content of...
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ARQon
Apr 2, 20172 min read
Updates on Drugs - April 2017
Australia: Strengthening Monitoring of Medicines in Australia Canada: Notice: Guidance Document - Fees for the Right to Sell Drugs...
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ARQon
Sep 5, 20161 min read
Release of two draft guidance documents in US
The FDA recently released two draft guidance documents: "Deciding When to Submit a 510(k) for a Change to an Existing Device,” which...
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