Regulatory Q&A Forum

I'm ready to engage a CH-REP provider but want to ensure I provide all necessary information upfront to get accurate quotes and avoid delays. What should I prepare?

I'm trying to understand the distinction between CH-REP, importer, and distributor roles in Switzerland. Can a single company fulfill multiple roles, and what are the implications?

I understand vigilance reporting is required, but I'm unclear on the Swiss-specific requirements and the CH-REP's role in serious incident and FSCA reporting. Can you clarify the process?

I'm confused about technical documentation requirements for CH-REP. Does the CH-REP need to physically hold the technical file, or can the manufacturer provide it directly? What are the timelines?

I need to update my device labeling for the Swiss market. What are the specific requirements for indicating the CH-REP on labels, packaging, and IFU? Can I use the symbol or must I use text?

I keep hearing about CHRN (Swiss Single Registration Number) but I'm unclear on who needs it, the timeline, and costs involved. Can you break down the CHRN registration process?

Swissmedic requires a written mandate between the manufacturer and CH-REP. What are the essential elements that must be included to ensure compliance and operational effectiveness?

I need to understand the exact scope of CH-REP responsibilities. What are they legally required to do versus what they might offer as additional services? Also, what are common misconceptions about th...

I'm an EU manufacturer with CE marking under MDR/IVDR. I assumed I wouldn't need a CH-REP since Switzerland is similar to the EU, but I'm hearing conflicting information. Do EU manufacturers really ne...

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When pursuing a 510(k) submission using a 'split predicate' approach—combining key features from two or more legally marketed devices—how can a sponsor construct a robust substantial equivalence argum...

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When a sponsor receives a hold on their 510(k) submission, how can they distinguish between a Refuse to Accept (RTA) hold and an Additional Information (AI) request, and what are the critical differen...