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International Authority Certification

All products are complied with international and local standards and acquired authoritative certificates.

ISO13485

International requirements to medical device manufacturing enterprise about quality management system.
FDA-QSR820

Requirements before being listed in the United States and may be randomly checked at any time after being listed.
SMETA

Focus on Member Ethical Business to help auditors conduct high quality audits.
NMPA

The top medical device regulator in China.
CE

All medical devices entering into European market must be certified with CE.
FDA

International manufacturers are taking the FDA certification as the highest honor and guarantee of product quality.
PMDA

Medical device distribution in Japan market must meet PMDA regulations before launching.
HEALTH-CANADA

Manufacturers must apply to the Canadian Health Administration for authorization to sell their products in Canada.
ROHS

A mandatory standard made by the European Union legislation.