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.
South Korea’s Ministry of Food and Drug Safety (MFDS) identified certain raw materials prohibited from use in medical device production.
Medical device regulators in the US have extended their Unique Device Identification compliance deadline to September 24, 2016 for some implantable medical devices to provide more time for manufacturers of these devices to develop and implement workable UDI processes.
In order to qualify for the extension, a device must meet three key criteria:
The governments of Australia and New Zealand no longer plan to form a joint regulatory authority to oversee both countries’ medical device markets.
Brazilian medical device regulator ANVISA has begun accepting feedback from medical device companies subject to quality management inspections in order to improve and standardize inspection processes.
Canada’s medical device market regulator Health Canada has published new guidance requiring electronic formatting for most higher-risk Class III and IV Medical Device License (MDL) applications.
Revised medical device registration and approval requirements in Japan will become law November 25, 2014, and will impact several compliance areas for foreign manufactures active in the market, According to Emergo’s Tokyo office.
Recent findings by a nonpartisan US Congressional research agency suggests the much maligned Medical Device Excise Tax will have a “negligible” impact on overall health care costs in the US.
Brazilian medical device market regulator ANVISA has begun allowing automatic extensions for deadlines for market registrants to comply with new requirements issued by the regulator.
The Indian Drugs Controller General’s office has launched a new task force to review processes and procedures currently in place at the Central Drugs Standards Control Organization (CDSCO) in order to boost efficiencies in how medical devices and drugs are reviewed
Canadian regulators have updated their list of recognized standards pertaining to medical devices, affecting manufacturers applying to Health Canada for Medical Device Licenses (MDL).