On June 23, the Hunan Biomedical and Medical Device Industrial Chain Cooperation Conference was held in Beijing. During the event, the "Compliance Guidelines for International Operations of Biomedical and Medical Device Industrial Chain in Hunan Province" was released, providing systematic compliance guidance for Hunan enterprises expanding overseas markets.

The guidelines consist of six chapters, covering categories such as biomedicine, medical devices, and traditional Chinese medicine. They focus on interpreting ten major compliance areas, including anti-commercial bribery, intellectual property, cross-border data, and export controls. Additionally, the document refines compliance norms for new business formats such as out-licensing of innovative drugs and establishing new entities overseas, while also providing practical tools like risk assessment checklists and contract templates. The guidelines feature three key characteristics: keeping pace with industry frontiers, being tailored to Hunan enterprises, and being practical.

The guidelines were jointly launched by the China Council for the Promotion of International Trade (CCPIT) Hunan Sub-council, the Work Group on Biomedical and Medical Device Industrial Chain of Hunan Province, and the CCPIT Commercial Legal Service Center. A spokesperson for the CCPIT Hunan Sub-council noted that supporting services will be carried out, including specialized compliance trainings and on-site compliance reviews, and resources such as law firms specializing in cross-border legal services and industry associations will be coordinated to build a long-term compliance service ecosystem.

This article is from Hunan Provincial Government. www.enghunan.gov.cn.

Translator: Xiao Juan

Chinese source: hunan.gov.cn