Zi Medical provides services to assist the international medical device companies globally with China, US, EU as primary markets.. We provide one stop service to companies including regulatory strategy, submissions, quality management systems, regulatory authority engagement (meetings/enforcement action). Services we provide:-Regulatory Services * Regulatory Strategy for One or Multiple Markets* International Product New Registrations and License Renewal* Pre-submission Consultations and Fillings* GMP/QSD Registrations* Regulatory Management Development* Quality Compliance * Regulatory Staff Training* Chinese & Taiwanese Regulatory Guidance English Translations* Chinese & Taiwanese Testing Standards English Translations-Marketing Services* Business Strategy for Urgent Market* Marketing Research and Development* Distributor/ Partner Search* Continuing Process ImprovementRegions we cover:China, Taiwan, Hong Kong, Singapore, Japan, Korea, Malaysia, Philippines, Singapore, Indonesia, India, Thailand, Vietnam, New Zealand, Australia, etc..

Product Registration and Submission Compliance Audit and Remediation Process Improvment Regulatory Strategy Medical Devices GMP Registration QSD Registration Product License Renewal and Change Notification Translation Distribution Process Flows Product Registration and Submission Compliance Audit and Remediation Process Improvment Regulatory Strategy Medical Devices GMP Registration QSD Registration Product License Renewal and Change Notification Translation Distribution Process Flows Product Registration and Submission Compliance Audit and Remediation Process Improvment Regulatory Strategy Medical Devices GMP Registration QSD Registration Product License Renewal and Change Notification Translation Distribution Process Flows 510K 513G PMA Establishment Registration HIPAA GDPR IVD Regulatory Technology