By Stewart Eisenhart, Emergo Group
Emergo Group
November enforcement date for new pharmaceutical affairs law in Japan
By Stewart Eisenhart, Emergo Group
Japan’s Ministry of Health, Labour and Welfare (MHLW) has set a late November 2014 date to begin enforcing revised regulations (link in Japanese) for medical devices and pharmaceutical products.
New KSA Declaration of Conformity requirements in March 2014
By Stewart Eisenhart, Emergo Group
Latest guidance from U.S. FDA: Computational modeling, devices using animal sources
By Stewart Eisenhart, Emergo Group
The US Food and Drug Administration has released two new draft guidances for medical device manufacturers that either include computational modeling data in their registration applications or use animal-derived sources in their products.
Clarified reclassification rules from TGA for implantable devices
By Stewart Eisenhart, Emergo Group
Australia’s Therapeutic Goods Administration (TGA) will allow registered manufacturers of partial knee, hip and shoulder implants to submit summary technical reports as part of their reclassification applications through June 30, 2014.
Peruvian regulators update rules for importing unregistered medical devices
By Stewart Eisenhart, Emergo Group
Medical device market regulators in Peru have set up new special permission requirements (link in Spanish) for importing medical devices that have not yet been registered for sale in the country.
New INMETRO, IEC 60601 requirements in Brazil
By Stewart Eisenhart, Emergo Group
Brazilian regulators have issued new requirements under Normative Instruction 9/2013 that expand certification requirements for some electronic and other medical devices.
U.S. FDA provides 510(k) communication timeline
By Stewart Eisenhart, Emergo Group
IMDRF targets uniform standards for medical device auditors
By Stewart Eisenhart, Emergo Group
U.S. medical device tax 1 step closer to repeal
By Stewart Eisenhart, Emergo Group
The US Senate has joined the House in approving a new federal budget that includes provisions to repeal the Medical Device Excise Tax (MDET).
The budget bill now goes to President Obama for final approval; he has indicated he will sign the bill.
Chinese regulators to launch simplified registration renewal process in 2014
By Stewart Eisenhart, Emergo Group
The China Food and Drug Administration (CFDA) will implement a simplified certification renewal process January 1, 2014 for medical devices. With the exception of devices with major changes, manufacturers seeking to renew their medical device registrations in China will face fewer documentation requirements and potentially faster re-certifications.