Worldwide Medical Device Regulatory Updates
As medical device quality assurance and regulatory affairs professionals, it can be challenging to stay on top of changes happening in our industry. Few people have the time to read lengthy articles these days and although many online newsletters exist, they are often packed with PR releases, ads or unrelated information. That is why we started this blog for QA/RA professionals in the medical device and IVD industry. The idea is to give you short updates on quality and regulatory topics that may be of interest to you.
Canadian medical device market regulator Health Canada will begin requiring all reprocessed single-use medical devices to Canadian Medical Device Regulations (CMDR) by September 1, 2016.
The Saudi Food & Drug Authority (SFDA) has issued new guidance on labeling requirements for medical devices approved for sale in the Kingdom of Saudi Arabia (KSA).
Since its implementation in 2013 as part of the Affordable Care Act (ACA), the Medical Device Excise Tax (MDET) has drawn steady fire from industry trade groups and their allies in the US Congress. So far, however, lawmakers’ efforts to repeal the tax have fallen short due to opposing agendas of the Republican-led House of Representatives and the Democratic majority in the Senate.
Chinese medical device market regulator China Food and Drug Administration (CFDA) has published a draft table of user fees for medical device registrants, and is expected to begin enforcing fee requirements in March 2015.
India’s Central Drugs Standard Control Organization (CDSCO) is seeking comment on a new proposal to establish formal pre-submission consultations with firms seeking medical device registration in the country. The consultations would apply to devices as well as drugs and clinical trials.
The British Medicines and Healthcare products Regulatory Agency (MHRA), responsible for overseeing the UK’s medical device market, is launching a new online registration system for low-risk devices on February 11, 2015.
South Korean medical device regulators will implement significant changes affecting compliance requirements for medical device and in vitro diagnostic (IVD) registration as well as for Korean Good Manufacturing Practice (KGMP) audits over the course of 2015.
A new Brazilian law allows ANVISA, the country’s medical device market regulator, greater latitude to manage public health risks and surveillance measures in a way that may also boost efficiencies for Brazilian market registrants.
Roszdravnadzor, Russia’s medical device market regulator, has published a new system for nomenclature classification according to 19 different device types.