Here we inform you about events and news on reimbursement and regulatory issues.
The guideline issued by the FDA is regulatory flexibility, including a temporary waiver of the premarket notification requirements under Section 510 (k) of the Food, Drug, and Cosmetic Act.
Will applications for export certificates and confirmations be possible only for economic operators based in Switzerland assuming the role of manufacturer or Authorised Representative?
The MDCG has recently published helpful documents. Is your software a medical device? Is it actually a custom-made device?
When the HMV Application Gets Lost in Tranlation: dealing with the first response to your application from the GKV.
Uncertainty and questions in regards to „How and where do I obtain a UDI“ have been frequently brought to us in recent months. In a short overview we will show you possible way and provide you with relevant links to for further reading.
