CHINA Trends and Developments Contributed by: Min Zhu, Ya-ling (Michelle) Gon, Yang (Aaron) Gu, Chai Lu, Ying Li and Shiye Yuan, Han Kun Law Offices
In December 2025, the NMPA issued the Provisions on Administration of Certificates for Export and Sale of Medical Devices , which constitute an important measure to strongly support the exportation of medi- cal devices. The provisions classify such certificates into two categories, notably introducing a new certifi- cate targeting medical devices intended for exporta- tion that have not been registered or filed in China. The issuance of the provisions is expected to provide broader support and more convenient services for the exportation of China’s medical device products. Compliance Practices The PRC authorities have launched anti-corruption ini- tiatives in the pharmaceutical industry that continued to be very active in 2025, building on the momentum established in 2024. From legislation to enforcement, the fight against corruption has been more advanced and sophisticated against healthcare professionals (HCPs) in hospitals, clinics and institutions. Pharma- ceutical, medical device, and bio-science companies are often subject to investigations or requests to be co-operative in assisting with investigating HCPs. In the past, criminal bribery charges were principally pursued against bribe-takers; however, law enforce- ment is now also focused on criminal liability of bribe offerors. With tighter scrutiny, this trend will result in a higher deterrent effect, with an aim to reduce bribery and corruption activities. Commercial bribery in life sciences and healthcare In 2025, Chinese regulators sustained rigorous focus on anti-bribery and anti-corruption enforcement, promulgating a series of legislative and regulatory instruments to strengthen supervision over commer- cial bribery in the life sciences and healthcare indus- tries and to deliver targeted compliance directives. On 10 January 2025, the SAMR officially released the Guidance on Preventing Commercial Bribery Risks for Pharmaceutical Enterprises (the “Guidance”) with immediate effect. The Guidance aims to assist phar- maceutical and medical device enterprises in effec- tively preventing and addressing commercial bribery risks during their daily operations, ensuring compli- ance with relevant laws and regulations. Nine high-risk activities have been specifically targeted, including: interactions with healthcare professionals, hospitality,
consulting, rebates, donations, equipment placement, clinical trials, retail sales and use of third parties. On 13 May 2025, the NHC, along with 13 other PRC government departments, issued the Notice on Issu- ing the Key Points for Correcting Unhealthy Practic- es in the Field of Pharmaceutical Procurement and Medical Services in 2025 (the “Notice”). The Notice focuses on addressing malpractice within key areas and critical links in the pharmaceutical procurement and sales sector, and on holding all departments fully accountable for their primary responsibilities in full- cycle supervision. The Notice further provides for the refinement of a “blacklist” regime targeting bribe offerors and bribe-takers, together with a misconduct recording system for related entities engaged in phar- maceutical procurement and sales. Released by the General Office of the National Health- care Security Administration (NHSA) on 5 June 2025, the Notice on Further Improving the Credit Evaluation System for Pharmaceutical Prices and Procurement has intensified anti-corruption efforts in pharmaceu- tical price and procurement through stricter credit evaluation and disciplinary measures, with a focus on curbing commercial bribery and bid-rigging, so as to raise the cost of dishonesty for pharmaceutical enterprises and to guide them towards operating in an honest and compliant manner. On 21 September 2025, the Standing Committee of the Central Commission for Discipline Inspec- tion (CCDI) issued an article further urging discipline inspection and supervision authorities at all levels to uphold the strict tone in advancing the improvement of work style, enforcement of discipline, and combat- ing corruption. The article seeks to rectify corruption in power-concentrated, capital-intensive and resource- rich sectors such as pharmaceuticals, finance and SOEs, drives overall progress through breakthroughs in key areas, and continuously expands the depth and breadth of the actions against corruption. Effective on 15 October 2025, the Amendment to the Anti-Unfair Competition Law explicitly established penalty mechanisms applicable to bribe offerors and bribe-takers, covering corporate entities and individ- ual parties alike. Enterprises face a maximum fine of
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