immunofluorescence reagents
Blockbuster!Xiamen Biotime has been awarded MDSAP certification Jul 22, 2022


Recently, Xiamen Biotime Biotechnology Co., Ltd. completed the Medical Device Single Audit Program (MDSAP) and obtained the MDSAP certification issued by the international certification body SGS.




MDSAP Certification Program

It is co-sponsored by members of the International Medical Apparatus Regulators Forum (IMDRF) and recognized and joined by regulators in the United States (FDA), Australia (TGA), Brazil (ANVISA), Canada (HC), and Japan (MHLW). A new audit procedure allows medical apparatus manufacturers to undergo only one quality management system audit to meet the standards and regulatory requirements of the above five countries. The audit work is carried out by an audit body authorized by the regulatory agencies of the five countries.


As a high-tech enterprise specializing in the research and development, production and sales of in vitro diagnostic reagents and instruments, Xiamen Biotime Biotechnology Co., Ltd. always adheres to the quality policy of 'product-oriented, innovation-oriented, management-oriented, and service-oriented', and strictly controls product quality management.

Obtaining the MDSAP certification will further bring advantages and convenience to Xiamen Biotime's products to obtain overseas market access qualifications, and accelerate the pace of the company's global development strategy.

In the future, Xiamen Biotime Biotechnology Co., Ltd. will continue to help the global epidemic prevention and control work, be committed to providing high-quality in vitro diagnostic products to more countries and regions around the world, and contribute to the development of the global biomedical industry.






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