Certifications

COMPLIANCE FIRST

Our Regulatory Commitment

Every product we trade is backed by rigorous regulatory compliance. We work exclusively with manufacturers whose products carry the certifications required for their target markets — ensuring clients receive products that are safe, legal and ready for immediate use.

ISSUED CERTIFICATES

NMPA REGISTRATION CERTIFICATES

NMPA · Class II

Medical Device Business Filing Certificate

Class II Medical Device Business Filing Certificate (苏苏药监械经营备 20198013号) issued by the Suzhou Market Supervision Administration, authorising wholesale distribution of Class II medical devices across the Chinese market.

NMPA · Licence

Medical Device Business Licence

Medical Device Business Licence (苏苏药监械经营许 20198006号) valid from March 2026 to January 2029, confirming full regulatory authorisation for the wholesale distribution of Class II medical devices and IVD products in China.

INTERNATIONAL FRAMEWORKS

REGULATORY STANDARDS WE FOLLOW

ISO 13485

International standard for quality management systems in medical device manufacturing. All partner manufacturers comply with ISO 13485, ensuring consistent product quality and process control throughout production.

CE Mark

European conformity certification indicating products meet EU safety, health and environmental protection requirements. CE-marked products in our portfolio are approved for distribution across all EU member states.

NMPA Registration

China's National Medical Products Administration (formerly CFDA) registration ensures our products meet China's stringent market access requirements. We manage the full registration process on behalf of clients.

GMP Compliance

Good Manufacturing Practice compliance is verified across all partner production facilities. Regular factory audits ensure manufacturing environments, processes and documentation meet international GMP standards.

HOW WE ENSURE COMPLIANCE

Our Compliance Verification Process

Before any product enters our portfolio, it undergoes a thorough compliance review. We verify registration status, audit manufacturer credentials and confirm certificates are valid and current for all relevant markets.

Certificate Verification All product registration certificates are verified directly with the issuing authority before acceptance into our product range.

Manufacturer Audit Partner factories are audited for ISO 13485 and GMP compliance, with periodic re-audits to ensure ongoing standards are maintained.

Document Management We maintain complete, up-to-date compliance documentation for every product — available to clients on request for their own regulatory filings.

Ongoing Monitoring Regulatory changes are actively monitored across all target markets. We proactively update clients when new requirements affect their products.

Our Regulatory Commitment

Medical Device Business Filing Certificate

Medical Device Business Licence

ISO 13485

CE Mark

NMPA Registration

GMP Compliance

Our Compliance Verification Process

We Handle Your Regulatory Needs End-to-End

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