About GRZAN Group

Your trusted partner for global regulatory compliance in medical devices and IVD

GRZAN is a global technical service provider specializing in comprehensive support for medical device and in vitro diagnostic (IVD) companies. We help manufacturers successfully navigate international market access, clinical evidence generation, testing and compliance requirements, and post-market regulatory obligations. With years of industry experience, we have established a strong presence across major global markets and built an extensive localized service network.

To date, GRZAN has developed a worldwide operational network with subsidiaries and localized teams in key international markets, enabling deep local engagement and efficient project execution. Our localized service capabilities currently extend across the United States, Germany, Spain, Russia, Singapore, Malaysia, Indonesia, Vietnam, Thailand, the Philippines, Brazil, Mexico, Colombia, Argentina, Peru, Saudi Arabia, Bangladesh, India, South Africa, and Australia.

Within China, GRZAN also maintains a strong operational presence through self-operated entities located in Hong Kong SAR, Shenzhen, Guangzhou, Suzhou, Nanjing, Changsha, Beijing, Shanghai, Hangzhou, and Changzhou.

Our Core Services

  • Global Regulatory Consulting Expert support for market access across key jurisdictions worldwide, including China NMPA, Singapore HSA, Malaysia MDA, Indonesia BPOM, Vietnam MOH, Thailand TFDA, Philippines FDA, Brazil ANVISA, Argentina ANMAT, Colombia INVIMA, Mexico COFEPRIS, Saudi Arabia MDMA, UAE MOHAP, Russia RZN, EU CE-MDR & IVDR, U.S. FDA & 510(k), UK MHRA & UKCA, Canada MDL & MDEL, Australia TGA, India CDSCO, as well as registration services throughout CIS countries and African markets.
  • International Clinical Trials Global clinical evidence compliance services aligned with MDR/IVDR, FDA, and other international regulatory requirements, including clinical strategy and protocol design, investigational site coordination, clinical trial monitoring, and clinical evaluation/report generation.
  • Testing & Quality Management System Support Evaluation of applicable standards for product performance and safety testing, together with quality management system consulting services covering MDSAP, ISO 13485, QSR 820, BGMP, and Russia GOST requirements.
  • Global Authorized Representative Services: Comprehensive local representation services, including ASEAN License Holder support, Latin America License Holder services, European Authorized Representative (EU Rep), U.S. Agent, UK Responsible Person (UKRP), Australia Sponsor, as well as localized authorized representative services across the Middle East, Africa, and other international markets.

With a global service network and localized teams, GRZAN delivers one-stop regulatory solutions to help clients enter international markets with speed and compliance.

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