Introduction of medical device product certification services for ce fda ukca mdr
Are you seeking international certification for your medical products? I offer expert consultation services to ensure regulatory compliance across key global markets, including FDA cGMP (USA), MHRA UKCA (UK), European MDR CE (EU), SFDA (Saudi Arabia), TFDA (Thailand), among others. My comprehensive services range from documentation and regulatory submissions to conducting audits and ensuring compliance, guiding you through each stage to ensure your product aligns with the regulatory standards of your target countries. Let’s streamline your journey to achieving global market readiness and compliance.
Our expertise spans a wide array of regulatory frameworks, including:
EU: Medical Device Regulation (MDR), In Vitro Diagnostic Regulation (IVDR)
US: FDA 510(k), Premarket Approval (PMA), Investigational Device Exemption (IDE)
UK: UKCA Marking, MHRA Regulations
Canada: Medical Device Licensing (MDL) program
Australia: Therapeutic Goods Administration (TGA) Regulations
Japan: Pharmaceuticals and Medical Devices Act (PMDA)
China: NMPA Regulations
Allow us to assist you in navigating the intricate landscape of global regulatory requirements and expedite your product's market launch.
| Shop Location | Japan |
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