CH-REP onboarding checklist: what to prepare to get accurate quotes (and start fast)

## CH-REP Onboarding Checklist: What to Prepare Preparing a comprehensive "CH-REP RFQ pack" upfront will help you get accurate quotes quickly and avoid back-and-forth delays. Here's what to prepare before engaging CH-REP providers: ### 1. Company + Supply Chain Information #### Legal Manufacturer Details - **Legal manufacturer name** (exactly as it appears on device labels) - **Complete legal address** (must match label) - **Company registration number** and jurisdiction - **Contact information** (regulatory contact, quality contact) #### Current Regulatory Status - **EU MDR/IVDR status**: - Do you have CE marking? - Which notified body (if applicable)? - Certificate numbers and expiry dates - **Declaration of Conformity (DoC) availability**: Can you provide current DoC? - **Other market authorizations**: FDA, Health Canada, TGA, etc. #### Current Swiss Market Setup - **Current importer/distributor setup** for Switzerland (if known) - Who currently imports your devices? - Who distributes in Switzerland? - Are these relationships formalized? - **Current market presence**: Are you already selling in Switzerland, or is this new entry? ### 2. Device Scope #### Device Families - **List of device families** you want to place on the Swiss market - **Intended purposes** and indications for use - **Risk classifications**: - Medical devices: Class I, IIa, IIb, III - IVDs: Class A, B, C, D - **Generic device groups** (if applicable) #### Device Types - **IVD vs. "classic" medical device** (or both) - **Active vs. non-active devices** - **Implantable vs. non-implantable** - **Single-use vs. reusable** #### Market Scope - **Switzerland only** vs. **Switzerland + Liechtenstein** (often treated together due to customs union) - **Expected sales volume** (helps CH-REP understand workload) - **Distribution channels** (hospitals, clinics, retail, etc.) ### 3. Compliance Operations #### Technical Documentation - **Who holds technical documentation today?** - Is it with your EU-REP? - Is it with your quality department? - Is it with a third-party consultant? - **How quickly can you provide it** if Swissmedic requests it? - Can you meet the 7-day expectation? - What format is it in? - Is it complete and up to date? - **Documentation readiness assessment**: Be honest about gaps #### Vigilance Process - **Who owns your vigilance process?** - Internal quality/regulatory team? - External consultant? - EU-REP? - **Do you want the CH-REP to actively manage reporting**, or just ensure it happens? - **Current incident reporting capabilities**: How do you handle incidents today? - **FSCA experience**: Have you issued FSCAs before? #### Quality System - **Quality system certification**: ISO 13485, MDSAP, etc. - **Notified body** (if applicable) - **Audit schedule**: When was your last audit? ### 4. Labeling #### Current Labeling Status - **Where can you add CH-REP name/address?** - Device label (if space permits) - Packaging - IFU (Instructions for Use) - Accompanying documents - **Label print run schedule**: When is your next label print run? - This affects how quickly you can add CH-REP information - **Labeling constraints**: Space limitations, language requirements, etc. #### Labeling Updates - **Can you update labeling quickly** if needed? - **Do you have in-house labeling capabilities**, or do you use a contract manufacturer? - **UDI implementation**: Are your devices UDI-compliant? ### 5. Timeline and Budget #### Market Entry Timeline - **When do you want to start selling in Switzerland?** - **Are there any hard deadlines** (product launches, contracts, etc.)? - **How much time do you have** for CH-REP onboarding? #### Budget Considerations - **Budget range** for CH-REP services - **Expected device volume** (affects pricing) - **Service level expectations** (basic compliance vs. full-service support) ### 6. Additional Information #### Special Requirements - **Any special device characteristics** that might affect CH-REP requirements? - **Custom device configurations** or procedure packs? - **Software as a Medical Device (SaMD)** components? #### Previous Experience - **Have you worked with CH-REPs before?** - **Any lessons learned** from previous market entries? - **What worked well, what didn't?** ### What CH-REP Providers Need to Quote Accurately When you provide this information, CH-REP providers can: - ✅ Assess the scope of work accurately - ✅ Identify any special requirements or challenges - ✅ Provide realistic timelines - ✅ Give accurate pricing - ✅ Identify potential issues early - ✅ Propose appropriate service levels ### Red Flags if CH-REP Doesn't Ask If a CH-REP provider gives you a quote without asking about: - Device scope and classifications - Technical documentation readiness - Vigilance process capabilities - Labeling constraints - Timeline requirements ...be cautious. They may not be doing proper due diligence. ### Next Steps After Preparing Your RFQ Pack 1. **Send to multiple CH-REP providers** - Get 3-5 quotes for comparison 2. **Ask clarifying questions** - Don't assume anything 3. **Compare service levels** - Not just prices 4. **Check references** - Talk to other manufacturers they work with 5. **Review contracts carefully** - Ensure mandates include all essential elements --- *Written by **Lo H. Khamis**, Regulatory Experts. [Connect on LinkedIn](https://www.linkedin.com/in/lo-h-khamis) for regulatory guidance.* ### Official Sources: - [Swissmedic - Market Entry Requirements](https://www.swissmedic.ch/swissmedic/en/home/medical-devices/economic-operators.html)