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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 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.
Canadian medical device market regulators have begun soliciting manufacturers to participate in a pilot version of a nascent international quality management system auditing program, the Medical Device Single Audit Program or MDSAP.
In February, Emergo will release its annual analysis of FDA 510(k) review times for 2014 and prior years. During our analysis, we uncovered some interesting facts (at least to RA professionals) we wanted to share.
For instance, did you know...
Mexican regulators have expanded their list of healthcare products that do not require registration and approval to be sold in the country.
The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) has formally launched a new database compiling all guidance documents pertinent to medical device manufacturers with products registered for sale in the US.
India’s health ministry, the Department of Health and Family Welfare, will submit proposed changes to the country’s medical device and pharmaceutical laws to Parliament in 2015.
Chinese government officials have agreed to reduce registration timelines for US medical device manufacturers during bilateral trade talks in Chicago.
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.