Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at email@example.com if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Regulatory News | 21 August 2014 | By Louise Zornoza
This content is provided by RegLink News, publishers of e-weekly global regulatory news. RegLink offers a 30-day free trial and 15% discount on Global Update subscriptions to RAPS members.
Australia’s Therapeutic Goods Administration (TGA) has announced that it will initiate the reassessment of the clinical evidence for all urogynecological surgical mesh implants to determine if they comply with the requirements for safety and performance necessary for marketing approval.
The reassessment was prompted by the results of a review of the implants by the TGA’s Urogynecological Devices Working Group that found that, while there may be a benefit in certain patients, there is little evidence to support the overall effectiveness of these devices as a product class.
Where individual mesh devices are found to be non-compliant, the agency will initiate regulatory action, such as the cancellation or suspension of the marketing approval for the device.
Tags: Vaginal Mesh, Urogynecological Surgical Mesh