Quality Certifications & Regulatory Compliance

CE Mark · ISO 13485:2016 · ISO 9001:2016 · Japan MOH · Brazil ANVISA · FDA Compliant

Every Fizza Surgical instrument is manufactured under internationally recognised quality management systems, ensuring safety, reliability, and regulatory compliance for healthcare professionals and distributors in all global markets.

Our Commitment to International Quality Standards

At Fizza Surgical International, quality is not a department — it is a culture embedded in every step of our manufacturing process. Our certifications are independently verified by accredited third-party bodies and renewed through annual surveillance audits, giving our customers continuous assurance of our quality standards.

CE Mark

European Medical Device Regulation 2017/745

CE Mark — European Conformity Certification

Fizza Surgical International holds the CE Mark certification in compliance with the European Medical Device Regulation (EU MDR 2017/745). The CE Mark demonstrates that our surgical instruments conform to the essential safety and performance requirements set by the European Union for medical devices entering the European Economic Area.

This certification confirms that our instruments have been independently assessed and verified to meet European standards for biocompatibility, sterilisation compatibility, mechanical performance, and product labelling. Healthcare facilities and distributors across the EU can import and use Fizza Surgical instruments with full regulatory confidence.

ISO 13485:2016 — Medical Device Quality Management System

ISO 13485:2016 is the internationally recognised standard specifically designed for Quality Management Systems (QMS) in the medical device industry. Our certification under ISO 13485:2016 demonstrates that Fizza Surgical has implemented a comprehensive QMS covering design and development, manufacturing, storage, distribution, and post-market surveillance.

This standard ensures that every process in our production chain — from raw material procurement to final product release — follows documented, controlled, and audited procedures that consistently produce safe and effective medical devices. ISO 13485 certification is a prerequisite for regulatory approvals in most major global markets.

ISO 13485:2016

Medical Device Quality Management System

ISO 9001:2016

Quality Management System

ISO 9001:2016 — Quality Management System

ISO 9001:2016 is the world’s most widely recognised quality management standard, providing the framework for consistent product quality and continuous improvement across all organisational processes. Our ISO 9001 certification demonstrates commitment to quality at every organisational level — from leadership to the production floor.

Combined with our ISO 13485 medical device-specific certification, ISO 9001 ensures our business management, customer service, procurement, and support processes all operate under a rigorous, audited quality framework. This dual certification gives buyers the highest possible assurance of consistency and quality.

Additional Regulatory Registrations

Beyond our core ISO and CE certifications, our instruments are registered with multiple national regulatory agencies, enabling compliant distribution in Japan, Brazil, the United States, and other major markets.

Japan Ministry of Health Registered

Fizza Surgical instruments are registered with the Japan Ministry of Health, Labour and Welfare (MHLW), meeting Japan's stringent requirements for imported medical devices. This registration allows compliant import and sale through Japanese medical distributors and healthcare channels.

Brazil ANVISA Registered

Our instruments are registered with Brazil's ANVISA (Agencia Nacional de Vigilancia Sanitaria), the national health regulatory agency. This registration allows compliant import and distribution throughout the Brazilian healthcare market, which has strict requirements for foreign medical device manufacturers.

FDA-Compliant Manufacturing

Our manufacturing practices align with US FDA requirements for Class I surgical instrument manufacturers (21 CFR Part 880). Our quality management systems, documentation, and manufacturing controls support our customers' FDA clearance and registration processes for the United States market.

German-Grade Material Standards

All Fizza Surgical instruments are manufactured from German-grade stainless steel — specifically AISI 420 martensitic stainless steel for cutting instruments and AISI 410 for non-cutting instruments requiring superior corrosion resistance.

These materials comply with EN ISO 7153-1 (stainless steels and non-ferrous metals for surgical instruments) and are verified through material certification from our steel suppliers. Chemical composition and mechanical properties are documented for every batch, providing full material traceability.

Sterilisation Compatibility

All Fizza Surgical instruments are tested and validated for compatibility with standard sterilisation methods used in hospitals and surgical centres worldwide. Our instruments are designed to maintain their mechanical properties and surface integrity through repeated sterilisation cycles.

Compliance is verified according to EN ISO 13402 (determination of resistance to autoclaving), giving healthcare facilities full confidence in instrument longevity and performance over their working life.

What Our Certifications Mean for You

Request Certification Documents & Test Reports

Need original CE certificates, ISO certification documents, Declaration of Conformity, or material test reports for your import requirements? Our export team responds within 24 hours.