Global registration service supporting medical device manufacturers through end-to-end regulatory compliance and market authorization across international jurisdictions. Streamlines the submission and approval process for medical devices and IVDs seeking global market access.
Manufactured by
China
Founded in 2004, a global medical device industry service provider and regional medical device industry operator. Leveraging experience serving 5,000+ global clients and obtaining 3,000+ global certifications, provides integrated services including medical-engineering translation, R&D design, global registration, global clinical trials, and manufacturing (CDMO+CMD+CRO).
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Beijing Zhongguancun Shuimu Medical Technology Co., Ltd. · China
Regulatory consulting service providing guidance on global medical device registration, GMP establishment, and compliance audits. Assists manufacturers in navigating international regulatory requirements and preparing for quality system inspections.
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Global regulatory consultation system providing guidance on international standards and certification requirements for medical device registration. Facilitates market entry and compliance.
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Comprehensive registration and filing services for medical devices in domestic and international markets. Supports product registration, manufacturing licenses, and operational certifications for medical device companies.
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