By Stewart Eisenhart, Emergo Group
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.
The Medical Device Business Journal — Medical Device News & Articles | MassDevice
By Stewart Eisenhart, Emergo Group
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.
By Stewart Eisenhart, Emergo Group
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.
By Stewart Eisenhart, Emergo Group
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.
By Stewart Eisenhart, Emergo Group
Chinese government officials have agreed to reduce registration timelines for US medical device manufacturers during bilateral trade talks in Chicago.
By Stewart Eisenhart, Emergo Group
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.
By Stewart Eisenhart, Emergo Group
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.
By Stewart Eisenhart, Emergo Group
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.
By Stewart Eisenhart, Emergo Group
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.
By Stewart Eisenhart, Emergo Group
South Korea’s Ministry of Food and Drug Safety (MFDS) identified certain raw materials prohibited from use in medical device production.
By Stewart Eisenhart, Emergo Group
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:
By Stewart Eisenhart, Emergo Group
The governments of Australia and New Zealand no longer plan to form a joint regulatory authority to oversee both countries’ medical device markets.