Medical Device Regulatory Consulting Services

How Cisema Supported Inox Torres Group, S.L. in Successfully Renewing its China Manufacture License (SELO) for Level A2 Pressure Vessels

The China Manufacture License (CML), also known as the SELO license, is a mandatory requirement for manufacturers of pressure equipment intended for the Chinese market. Inox Torres Group, S.L.’s manufacturing site produces high-pressure vessels falling under the Level A2 scope. This license ensures compliance with China’s stringent quality and safety regulations for special equipment.

The Challenge: Managing SELO Complexity for High-Risk Equipment

Renewing a SELO license for Level A2 pressure vessels required careful coordination across regulatory, technical, and cultural dimensions.

• Navigating Regulatory Complexity
  Navigating the complex and evolving SELO regulatory framework, particularly for high-risk products under Level A2, required meticulous planning and real-time compliance updates.

• Ensuring Audit Readiness
  Inox Torres Group, S.L. needed to ensure all documentation and procedures were fully up to date and to select an appropriate demo product that met inspection requirements.

• Managing Inspector Expectations
  Success depended on understanding the unspoken cultural and procedural expectations of SELO inspectors, including hosting and on-site hospitality.

Our Solution: Full-Spectrum SELO Audit Support

Recognizing the high stakes of SELO license renewal, Inox Torres Group, S.L. engaged Cisema for comprehensive regulatory and strategic support.

• Reviewed the Quality Management System
  Cisema led the review and upgrade of the customer’s quality management system in line with the latest Chinese requirements, including a comprehensive gap analysis and revision of key documentation.

• Audit Simulation & Preparation
  A preparatory remote audit simulation was conducted, walking through every step of the audit to ensure full readiness ahead of the on-site inspection.

• Delivered On-Site Bilingual & Regulatory Support
  During the on-site audit, Cisema provided continuous bilingual support, interpreting inspector questions in real time and translating regulatory nuances for the customer.

• Provided Culturally Appropriate Inspector Hosting
  Cisema arranged culturally appropriate corporate hospitality, helping establish a respectful and positive tone for the inspection. The team remained onsite throughout all audit days, including the weekend, to ensure no detail was overlooked.

The Outcome: Successful Renewal Without Disruption

Through hands-on execution and close coordination, the SELO renewal process was completed smoothly and efficiently.

• Secured CML Renewal with Full A2 Status
  Inox Torres Group, S.L. successfully renewed its China Manufacture License for pressure vessels, maintaining its Level A2 classification.

• Executed the Project Efficiently
  Full regulatory preparation and audit execution were completed within six months.

• Achieved Seamless Inspector Coordination
  SELO inspectors were hosted and coordinated smoothly, with culturally aligned engagement throughout the audit.

• Secured Regulatory Continuity  
  The renewal avoided operational disruptions and ensured compliance with updated SELO requirements.

Expertise and Efficiency: Acting as an Extension of the Client Team

Cisema’s experienced consultants acted as an extension of Inox Torres Group, S.L.’s regulatory and quality teams, providing both regulatory expertise and strategic foresight. Inspector concerns were anticipated and addressed proactively, transforming a potentially stressful process into a streamlined, well-orchestrated engagement with Chinese authorities.

Hands-on mentoring throughout the project helped the customer gain confidence and clarity in managing future SELO audits.

Why Choose Cisema

• Strategic Regulatory Expertise: Deep understanding of Chinese bureaucracy, evolving SELO requirements, and inspector expectations.

• Mentorship & Training: Step-by-step guidance that supported the customer’s quality team throughout the process.

• Corporate Hospitality Excellence: Culturally aligned hosting that supports successful audit outcomes in China.

• Audit Readiness & Precision: Gap analysis, audit simulation, and documentation refinement to pass SELO reviews efficiently.

• End-To-End Support: Full management of the audit process, from document revision to on-site interpretation.

Further Information

Explore Cisema’s China Special Equipment (SELO) Certification services.

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