Regulatory
Hong Kong offers tips on listing medical devices
Manufacturers of medical devices approved for marketing in one or more of the Global Harmonization Task Force’s founding member jurisdictions by Dec. 31, 2004, may skip a key requirement for listing their products in Hong Kong, says a recent directive from the Medical Device Control Office.
Hong Kong offers tips on listing medical devices
Manufacturers of medical devices approved for marketing in one or more of the Global Harmonization Task Force’s founding member jurisdictions by Dec. 31, 2004, may skip a key requirement for listing their products in Hong Kong, says a recent directive from the Medical Device Control Office....
Big changes in Canadian drug laws coming in Bill C-51
Important changes to Canada's food and drugs laws have been introduced in Bill C-51 to the Canadian House of Commons by the Canadian federal government. ...
Global harmonization task force wants opinions on documents
The objective of the GHTF is to encourage convergence at the global level of regulatory systems of medical devices to facilitate trade while preserving the right of participating members to address the protection of public health by regulatory means considered most suitable. ...
Congress pushes for Medical Device Safety Act of 2008 despite industry's objections
Congressmen and Senators are proposing the Medical Device Safety Act of 2008 to protect patients from dangerous and defective devices. Medical-device industry leaders say it will lead to confusion and affect medical care....
What you should know about electronic medical-device reporting
FDA regulations require companies to immediately notify the agency when a company receives complaints of device malfunctions, serious injuries, or deaths...
Foreign FDA offices a good idea. But who pays?
It's easy to get frustrated with the FDA because it is usually slow acting and risk-adverse. So now comes news the Agency is setting up offices and labs...
A guide to international regulatory compliance
Huron Consulting Group created the 2008 International Medical Device Compliance Code Compendium which provides regulatory guidance regarding interaction with healthcare professionals in 65 countries. ...
What do TV channels have to do with medical devices? You need to know.
You've probably heard that television broadcasts are transitioning from analog to digital in February 2009. Digital channels uses less power and less bandwidth, so there's no need for what are called geographical guard bands. For example, in a city that has TV channel 19, the station may also license channels 18 or 20, which are practically unused, to prevent broadcasting interference....
Minnesota university launches regulatory studies
Like most government bureaucracies, the FDA is a challenge to deal with. To make it easier, St. Cloud State University in Minnesota has begun a program...
FDA appoints Chief Scientist
Dr. Frank M. Torti, a clinician and researcher from Wake Forest University School of Medicine in Winston-Salem, N.C. will serve as Principal Deputy Commissioner and new Chief Scientist. ...
