MEDTECH NEWS

China's National Medical Products Administration (NMPA) has issued Notice No. 14 of 2026, releasing new inspection guidelines aligned with the revised Medical Device Production Quality Management Regulations (GMP), which take effect November 1, 2026. The guidelines replace the 2015 version and set out transition arrangements, risk-based post-market inspection requirements, and specify that sterile, implantable, IVD reagent, custom denture, and standalone software devices must comply with both the new GMP and existing appendix requirements.

On June 8, 2026, China's NMPA, jointly with three other national health authorities, issued the revised "Good Clinical Practice for Drug Clinical Trials," effective September 1, 2026, replacing the 2020 version. The update aligns closely with ICH E6(R3), restructuring the GCP into six chapters and adding a new Data Governance chapter to strengthen data reliability and traceability. It sharpens accountability—designating principal investigators as ultimate on-site responsible parties and sponsors as bearing final trial responsibility—while reinforcing participant protections, particularly for vulnerable populations and informed consent.

China's National Medical Products Administration (NMPA) issued Announcement No. 52 (2026) on June 1, 2026, establishing comprehensive procedural requirements for the registration and filing of medical devices — including in vitro diagnostic reagents — following regulatory classification adjustments. The announcement addresses a broad range of scenarios, including first-time registration, renewal, product changes, and transitions between filing and registration categories, while setting clear deadlines and responsibilities for both manufacturers and regulatory authorities. Products that fail to obtain valid registration or complete required filings before the applicable transition deadline will be prohibited from manufacture, distribution, and import. The announcement took effect immediately upon publication.

China's National Medical Products Administration (NMPA) has released updated regulations for medical device export sales certificates, effective May 1, 2026, replacing the 2015 version. The new rules establish two certificate types: Type I for devices already registered in China and Type II for unregistered devices whose manufacturers meet GMP standards. Applications will be processed within 20 working days through provincial authorities, with certificate validity capped at three years for Class I devices. The regulations introduce stricter accountability measures, including a five-year ban for fraudulent applications, while emphasizing that companies remain responsible for ensuring compliance with importing countries' requirements. The NMPA characterized the update as a service measure to facilitate medical device exports while maintaining quality and regulatory standards.

China's National Medical Products Administration updated policies to facilitate domestic production of imported Class II and III medical devices. The measures simplify registration through shared materials, prioritize innovative products, and ensure quality control through system inspections. These reforms aim to attract foreign investment, streamline processes, and enhance China's medical device industry.

China's National Healthcare Security Administration (NHSA) has issued new trial guidelines for neurological medical service pricing, reorganizing services into 82 basic items, 24 additional charges, and 8 expanded items. This reform enables provincial authorities to establish price benchmarks and allows local adjustments, advancing China's healthcare pricing standardization efforts.

China's NMPA has announced new guidelines (No. 22 of 2025) for medical device clinical trial inspections, effective May 1, 2025. The rules establish clear criteria for evaluating both pending applications and approved devices, focusing on authenticity and compliance. This update replaces 2016 and 2018 regulations, strengthening clinical trial oversight.

The Shanghai Municipal People's Congress has approved new Pharmaceutical and Medical Device Regulations, effective March 1, 2025. The regulations strengthen product supervision while promoting innovation, featuring digital oversight, streamlined approval processes, and enhanced quality management. Key focuses include R&D support, regional cooperation, and safety standards modernization.

China's State Council has announced two minor amendments to the Medical Device Supervision and Administration Regulations, set to take effect on January 20, 2025. The changes involve administrative authority adjustments and the removal of outdated terminology.

China's State Council has released comprehensive guidelines aimed at reforming drug and medical device regulation through 2035. The plan focuses on accelerating industry innovation, streamlining approval processes, and enhancing regulatory oversight to transform China into a global pharmaceutical powerhouse.

The General Office of the National Medical Products Administration (NMPA) of China has released a draft announcement titled "Announcement on Further Clarifying Matters Related to the Production of Imported Medical Device Products by Enterprises Within China (Draft for Comments)". The NMPA is now openly soliciting public opinions on this draft to deepen medical device regulatory reforms and promote high-level industrial openness, aiming to better meet the public's needs for medical devices.

China Beijing has announced a new initiative to streamline the import process for urgently needed drugs and medical devices on September 20, 2024. The Beijing Municipal Medical Products Administration, along with three other departments, has issued a trial implementation plan to create a "green channel" for the temporary import of clinically urgent medications and medical equipment.

China's National Medical Products Administration, in collaboration with the National Health Commission, has implemented regulations for the temporary import and use of essential medical devices in response to urgent clinical needs. The guidelines prioritize public health, outlining responsibilities, application processes, and usage requirements for medical institutions. The directive targets second and third-class medical devices unavailable domestically for critical life-saving treatments. Furthermore, the initiative ensures adherence to quality standards and patient safety in leading medical institutions. Ongoing support and training initiatives are planned to address specific medical needs effectively.

The National Medical Products Administration (NMPA) announced new regulations requiring all radiofrequency therapy devices and radiofrequency skin therapy devices to obtain valid medical device registration certificates by April 1, 2026, to ensure product safety and quality. Certificates expiring before this date can be extended until March 31, 2026.

NMPA has approved new measures to enhance the supervision of medical device clinical trial institutions. These measures, effective from October 1, 2024, aim to clarify regulatory responsibilities, standardize inspection procedures, and ensure the protection of trial participants' rights and safety. The initiative emphasizes the importance of trial quality and outcome authenticity. In support, the NMPA will soon release detailed inspection guidelines and conduct training sessions to improve regulatory capabilities.

The Guangdong Provincial Drug Administration has launched the "Guangdong-Hong Kong-Macao Greater Bay Area (GBA) Medical Pass," a pioneering policy initiative aimed at enhancing real-world medical research within the region. This policy facilitates the use of cutting-edge, clinically urgent medical products in designated institutions, thereby accelerating the approval processes and integrating real-world evidence into regulatory assessments. The initiative was highlighted through the introduction of the PROEM study at a conference in Guangzhou, focusing on the real-world efficacy and safety of Lemborexant in treating insomnia. The robust biopharmaceutical infrastructure in Guangdong supports a range from basic research to clinical applications, underpinning the region's leadership in drug and medical device innovation. As of March 2024, significant progress has been made with 19 institutions approved to participate and 59 types of medical products sanctioned for use, benefiting over 5,000 patients. Looking forward, Guangdong aims to further consolidate its role as a global biopharmaceutical hub by leveraging its industrial strengths and integrating resources across the GBA. This initiative not only underscores the region's commitment to scientific advancement and patient care but also sets a precedent for regulatory innovation in medical research across China.

On April 2, 2024, China's National Medical Products Administration (NMPA) introduced new guidelines to improve oversight of contract manufacturing in the medical device sector. These measures aim to ensure quality and safety by mandating registrants to maintain robust quality management systems, select capable contract manufacturers, and closely monitor the entire lifecycle of medical devices. Key aspects include the requirement for quality agreements, annual reviews, and stringent oversight by regulatory bodies. The initiative emphasizes collaboration between registrants and manufacturers, enhanced regulatory supervision, and the use of technology for efficient oversight. Set to be implemented on June 1, 2024, these guidelines mark a significant step towards ensuring the integrity and safety of medical devices produced through contract manufacturing.

The National Medical Products Administration (NMPA) is seeking feedback on draft regulations for the supervision and audit of clinical trial institutions for medical devices. These regulations aim to enhance management practices and standardize audit processes. The guidelines, developed in alignment with existing regulations and good clinical practices, outline 16 audit sections and 96 items, covering institution and clinical trial profession aspects. Defects are classified as severe, major, or general, with conclusions drawn based on the severity of non-compliance.

The Hengqin Guangdong-Macao In-depth Cooperation Zone introduces VAT and consumption tax refund policies effective from March 1, 2024, to boost economic integration and development, marking a strategic effort to enhance business and trade attractiveness by treating certain imported goods as exports and facilitating tax refunds for qualifying businesses, thus fostering greater economic synergy between Guangdong province and Macao.