In Brief: Swiss Regulators Moving to Online Medical Device Certification
Regulatory Updates | Medical Devices
Swissmedic, Switzerland’s medical device market regulator, will replace its current processes for issuing export certificates as well as manufacturing certificates with an online system in order to prevent delays and free up resources.
Swissmedic will launch the new system September 17, 2018, and has set a deadline of October 18, 2018 for transitioning from the current certification system. The change affects Swiss medical device companies that must obtain export certificates (FSCs) as well as manufacturing certificates (attestations) from Swissmedic in order to ship products to other markets.
Currently, export and manufacturing certificate applicants must submit hard copies of requests and associated documentation to Swissmedic. As applications for FSCs and attestations has increased, Swissmedic determined that automating its review process via online submissions will alleviate processing bottlenecks.
Related Swiss and European medical device regulatory information: