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.
A new law implemented in Canada, the Protecting Canadians from Unsafe Drugs Act, has expanded Health Canada’s oversight of the country’s medical device market in an effort to bring Canadian patient safety requirements more in line with international standards.
The Indian government has begun requesting pricing data from medical device and pharmaceutical product manufacturers in order to more tightly monitor extreme, potentially illegal price variations.
In conjunction with the recent implementation of the Pharmaceutical and Medical Device Law (PMDL), Japanese regulators have launched a new pre-consultation program to assist registrants as they begin their device certification application processes.
INVIMA, Colombia’s medical device market oversight agency, has added several “soft line” products to the list of medical devices that require registration in order to be legally sold in the country.
India’s Central Drugs Standard Control Organization (CDSCO) has proposed bringing the country’s Good Manufacturing Practice requirements for medical and in vitro diagnostic devices more in line with those of the ISO 13485 quality management system standard.
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.