Who holds the technical documentation, and how fast must it be provided to Swissmedic?

## Who Holds Technical Documentation, and How Fast Must It Be Provided? This is one of the most frequently **missed or misunderstood** operational requirements for CH-REP relationships. Understanding the documentation requirements and timelines is critical for compliance and avoiding regulatory issues. ### Swissmedic's Requirements According to Swissmedic's obligations sheet, the CH-REP must either: #### Option 1: CH-REP Holds the Technical Documentation The CH-REP physically maintains the technical documentation and can provide it directly to Swissmedic when requested. #### Option 2: Contractual 7-Day Submission Clause The CH-REP and manufacturer contractually agree that the **manufacturer will submit the documentation directly to Swissmedic within 7 days** upon request. **Both options are acceptable**, but the approach has significant operational implications. ### The 7-Day Requirement If you choose Option 2 (contractual access), the manufacturer must be able to: - Provide complete technical documentation to Swissmedic - Meet the **7-day deadline** from the time Swissmedic requests it - Ensure documentation is in the format and language required by Swissmedic - Have systems in place to respond quickly **This is a tight timeline**—7 days is not much time if your documentation is: - Scattered across multiple locations - Not well-organized - Missing key elements - In the wrong format or language ### Questions to Ask Your CH-REP Provider When selecting a CH-REP, explicitly ask: 1. **"Do you hold the tech file, or do you rely on a 7-day manufacturer submission clause?"** - Understand which model they use - Know what this means for your operations 2. **"What evidence do you need from us to be confident you can meet the 7-day window?"** - They should ask for documentation samples - They should verify your documentation is complete and accessible - They should test your response capability 3. **"What happens if we can't meet the 7-day deadline?"** - Understand the escalation process - Know the consequences of non-compliance - Have a backup plan 4. **"What format does Swissmedic require, and do you help with formatting?"** - Technical documentation must meet Swissmedic's requirements - Some CH-REPs provide formatting support ### This Clause is a Major Differentiator CH-REP providers handle documentation very differently: #### Full Document-Control Workflows Some CH-REPs: - Maintain complete technical files - Have document management systems - Provide ongoing document review and updates - Handle Swissmedic requests directly - **Higher cost, but lower risk** #### Contractual Access + Escalation Other CH-REPs: - Rely on manufacturer to provide documentation - Use contractual clauses to ensure access - Escalate to manufacturer when requests come in - **Lower cost, but higher operational burden on manufacturer** ### What Technical Documentation Includes Technical documentation typically includes: - Device description and specifications - Intended purpose and indications - Risk management documentation - Clinical evaluation reports - Labeling and IFU - Manufacturing information - Quality system certificates - Conformity assessment documentation - UDI information - Post-market surveillance data ### Best Practices 1. **Know Your Model** - Understand whether your CH-REP holds docs or relies on 7-day clause 2. **Prepare Documentation** - Have technical files organized and accessible 3. **Test Response Time** - Practice responding to documentation requests 4. **Document the Process** - Create SOPs for handling Swissmedic requests 5. **Maintain Relationships** - Keep communication open with your CH-REP about documentation status ### Red Flags - ⚠️ CH-REP that doesn't ask about your documentation readiness - ⚠️ No clear process for handling Swissmedic requests - ⚠️ Vague answers about the 7-day requirement - ⚠️ No testing or verification of your documentation capability ### Practical Recommendation If you're a small manufacturer or have limited regulatory resources, consider a CH-REP that offers full document-control workflows. The additional cost may be worth the reduced operational burden and lower compliance risk. If you have strong regulatory capabilities and well-organized documentation, a contractual access model may work well and be more cost-effective. ### Next Steps 1. **[Compare Swiss CH-REP providers & request quotes](https://cruxi.ai/regulatory-directories/ch_rep)** - Use our directory to find and compare qualified CH-REP providers --- *Written by **Lo H. Khamis**, Regulatory Experts. [Connect on LinkedIn](https://www.linkedin.com/in/lo-h-khamis) for regulatory guidance.* ### Official Sources: - [Swissmedic - Technical Documentation Requirements](https://www.swissmedic.ch/swissmedic/en/home/medical-devices/economic-operators.html)