China’s National Medical Products Administration (NMPA) has released six new guidelines to strengthen post-market surveillance and vigilance for medical devices. The updates set clearer expectations for quality management and require manufacturers and local agents (Marketing Authorization Holders) to have systems in place... Read More
On April 7, 2026, Beijing health authorities released a policy package with 32 measures to support innovative drugs and medical devices across the full lifecycle, from R&D to clinical use. Key actions include improving clinical trial infrastructure, accelerating regulatory review, and expanding... Read More
China’s National Medical Products Administration (NMPA) has released a long-term strategy titled “Implementation Opinions on AI + Drug Regulation.” This ambitious regulation aims to integrate AI across the full pharmaceutical regulatory lifecycle by 2035. The roadmap defines two key milestones. First, by... Read More
China has introduced market exclusivity and data protection mechanisms for the first time under the revised Regulations for the Implementation of the Drug Administration Law of the People’s Republic of China. The revised regulation is set to take effect in May 2026.... Read More
China will expand its Unique Device Identifier (UDI) requirements to cover a wider range of medical devices. Under the updated framework that will go into effect on June 1, 2027, all Class II medical devices, including in vitro diagnostic (IVD) reagents, and... Read More
On December 30, 2025, China’s National Medical Products Administration (NMPA) issued Announcement No. 134, which is expected to strengthen the oversight of local contract drug manufacturing. The regulation took effect immediately and provides a one-year rectification period. Companies that fail to comply may face... Read More
On January 7, 2026, China’s National Medical Products Administration (NMPA) announced measures to expedite the approval of drugs already approved outside of China that are urgently needed in clinical practice. The Centre for Drug Evaluation (CDE) will assess the clinical demand of... Read More
According to the Customs Tariff Commission of the State Council, China will begin reducing its import tariffs on several medical goods starting in 2026. The purpose of this policy is to allow for increased access to sophisticated medical technology like artificial blood... Read More
The National Reimbursement Drug List (NRDL) for 2025 has been announced by the Chinese government and includes 114 new entries, 50 of which are first-in-world innovative therapies. These additions show an increased focus from the government on making high-value medicines available to... Read More
India’s Central Drugs Standard Control Organization (CDSCO) has released the final list of risk classifications for oncology-related medical devices. The classification system, published on January 2, 2026, improves transparency concerning the regulation of cancer med-tech devices. It gives manufacturers of oncology devices... Read More