Regulatory Q&A Forum

I'm assembling procedure packs for the Swiss market and I'm confused about CH-REP requirements. Does each individual device component need its own Swiss Authorized Representative, or can one CH-REP co...

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...

For manufacturers of medical devices, including Class I products exempt from premarket notification, compliance with FDA's General Controls is a fundamental requirement. While concepts like Establishm...

When preparing a 510(k) for a device that introduces new technological features compared to its predicate—such as an orthopedic implant with a novel surface coating or a diagnostic software with a new...

When preparing a 510(k) submission for a Class II device that incorporates an incremental but significant technological change, such as an orthopedic implant with a novel surface material designed to ...

For a manufacturer of a Class I medical device, such as a non-sterile tongue depressor or an elastic bandage, that is exempt from 510(k) premarket notification, what constitutes a robust compliance fr...

For manufacturers of a 510(k)-cleared device, the decision between documenting a modification with a 'Letter to File' versus submitting a new 510(k) is a recurring challenge. Beyond the foundational r...

When a sponsor's new medical device incorporates significantly different technological characteristics compared to the chosen predicate—for example, a diagnostic imaging device using a novel AI/ML alg...

For a medical device company, particularly a startup, successfully navigating the FDA’s Small Business Determination (SBD) process is a critical step to manage costs associated with MDUFA user fees. S...

When preparing a 510(k) submission for a device with technological differences from its predicate—such as an electrosurgical generator featuring a modified energy delivery algorithm and a new user int...

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...

When preparing a 510(k) for a connected medical device, such as a networked patient monitor or a cloud-based SaMD, how can sponsors develop a cybersecurity documentation package that forms a cohesive,...