And nine elements:
1. Considerations in relation to risk: Regulators should assess product-specific risks based on complexity, supply chain transparency, and intended use while ensuring that CAPs are proportionate to the level of risk involved. Decisions should be evidence-based, relying on scientific research, best practices, and international standards to determine the appropriate level of regulatory confidence, with periodic reviews to adapt to technological and market changes.
2. Market Surveillance: Effective market surveillance requires balancing pre- and post-market controls based on national capacities and adopting risk-based approaches such as targeted sampling and testing. Regulatory authorities should have clear mandates to inspect, request information, and enforce compliance while maintaining strategic oversight, ensuring transparency, and remain independent from conformity assessment bodies.
3. International Standards, Guides, and Recommendations: Aligning conformity assessment procedures with international standards, such as ISO/IEC frameworks to facilitate trade, reduce costs, and ensure consistency across regulatory frameworks while enabling recognition of assessment results.
4. Confidence in Conformity Assessment: Ensuring confidence in conformity assessment bodies requires impartiality, oversight mechanisms, and strong data protection measures while promoting openness and recognition of assessment bodies from different regions. The use of digital technologies can further enhance transparency, improve supply chain integrity, and facilitate efficient conformity verification.
5. Acceptance of Conformity Assessment Results: To reduce duplicative testing and certification burdens, governments can rely on accreditation, mutual recognition agreements, and alternative regulatory cooperation approaches. Accepting conformity assessment results from internationally recognized bodies and leveraging existing regulatory frameworks can enhance efficiency and trade facilitation.
6. Transparency and Consultation: Stakeholder engagement and open communication are crucial for ensuring that conformity assessment procedures are well-designed, effective, and widely accepted, requiring transparent consultations and timely publication of relevant regulatory information.
7. Domestic Coordination: Collaboration between government agencies, the private sector, and national quality infrastructure institutions is necessary to avoid duplication of efforts and ensure that CAPs align with domestic and international best practices.
8. Development Considerations: Developing countries may face challenges in implementing CAPs, requiring technical assistance, capacity-building initiatives, and flexible regulatory approaches to facilitate their participation in international trade.
9. Flexibility and Agility: CAPs should be adaptable to technological advancements, market changes, and unforeseen crises, such as the COVID-19 pandemic, by integrating digital solutions and maintaining a dynamic regulatory approach