On 18 August 2017, President Trump signed HR 2430, the FDA Reauthorization Act of 2017 (FDARA), which became Public Law No 115-521. Principally, FDARA re-authorises the Food and Drug Administration’s (FDA’s) user fee programmes, including the Medical Device User Fee…
Interested parties have until 4 January 2018 to submit comments on Health Canada’s new fee proposal for pharmaceuticals and medical devices1. Canada’s medical device fees have not been updated since 2011, and those figures were based on 2007 costings. Although…
Regulatory authority Health Canada is the Federal department responsible for reviewing medical devices and in vitro diagnostic devices (IVD devices) to assess their safety, effectiveness and quality before being authorised for sale in Canada. Within Health Canada, the Health Products…
At the last moment, the US House and the US Senate have both passed a bill that suspends the controversial 2.3% medical device excise tax on the sale of a taxable medical device by the manufacturer, producer or importer for…
Regulatory authority Singapore’s healthcare regulatory framework consists primarily of: the regulator, which is the Ministry of Health along with its statutory boards; and the regulated, which are the public and private healthcare providers. Medical devices are regulated under the Health…
Consultation has been held on proposed increases to the fees payable1 under New Zealand’s Medicines Regulations 1984 – the first proposed increase in fees since 2006. With respect to medical devices, the cost of a Regulatory Statement to Foreign Government…
On 21 February 2018, the fees chargeable by registered Notified Bodies for auditing manufacturing sites in accordance with the Medical Devices Rules, 2017 were published by the Drugs Controller General (India)1. These fees have been approved by the Ministry of…
On 1 April 2018, Health Canada’s revised fee structure came into effect1. In line with Section 4 of the 2011 Fees in Respect of Drugs and Medical Devices Regulations, every fee outlined by the Regulations must be increased annually by…
