Comprehensive technical solutions for medical devices, cosmetics, pharmaceuticals, and health products entering global markets
Professional registration and certification services for major global markets
Comprehensive solutions including FDA registration, 510(k) premarket notification, De Novo classification requests, PMA applications, and Health Canada medical device licensing.
One-stop support for registrations and certifications across Latin America, covering key agencies and routes for efficient market entry strategies.
MDR/IVDR compliance support for EU CE marking, plus post-Brexit UKCA/MHRA and EAEU routes to help you access European and surrounding markets.
From NMPA (China) to TGA (Australia) and MFDS (Korea), we provide end-to-end regulatory strategy and submissions across APAC.
Efficient pathways into the GCC and surrounding countries, covering SFDA, MOHAP, TITCK and more.
Localized solutions for ASEAN members, including Thailand TFDA, Singapore HSA, Vietnam MOH, Philippines PFDA, Malaysia MDA and Indonesia MOH/BPOM.
End-to-end regulatory support across the Commonwealth of Independent States, from MoH registrations and EAC certifications to full regulatory compliance and localization strategies.
End-to-end support for SAHPRA, EDA, NAFDAC, PPB and more to help you expand efficiently across Africa.
Navigating Global Barriers, Accelerating Product Launch
GRZAN Group Limited (GRZAN) is a service provider focused on providing comprehensive technical services for global regulatory registration, clinical trials, and Inspection & Testing Guidance, etc. for medical devices and in vitro diagnostics companies.
Through years of development and accumulation, we have established a comprehensive service network and professional local teams in many important global markets, providing comprehensive market access services for medical device, cosmetic, pharmaceutical and health product companies.
Years Experience
Professional Team
Countries Covered
Successful Cases
Why companies choose GRZAN Group as their partner
4000+ successful cases, cooperation with over 3000 clients, with most listed companies choosing long-term cooperation with GRZAN.
More than 200 employees worldwide, with a technical team accounting for over 60% of the total workforce, all possessing extensive practical experience.
Subsidiaries and local teams established in USA, Germany, Spain, Hong Kong, Brazil, Russia, India, Indonesia, Vietnam, Malaysia, and across China.
Cooperation with 122 domestic clinical hospitals and over 200 overseas clinical centers. Strong relationships with notified bodies, testing institutions, and industry associations.
Core services: registration consulting + clinical trials + local authorized representative + system guidance + regulatory training + testing guidance.
Strict project management system with dedicated project managers ensuring smooth and efficient project completion.
Competitive pricing based on company situation and actual project workload.
ISO13485, ISO9001, ISO27001, Five-Star After-Sales Service Certification, National High-Tech Enterprise Certificate, and industry association leadership positions.
Trusted by leading companies worldwide
Get the latest global medical device development and regulatory news, insights and resources from our team.
Our expert team provides professional consultation and solutions for entering international markets
