China's NMPA Seeks Public Input on Draft for Local Production of Imported Medical Devices
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)" on November 4, 2024. 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.
Read MoreChina Beijing Establishes Green Channel for Importing Urgently Needed Drugs and Medical Devices
Beijing has announced a new initiative to streamline the import process for urgently needed drugs and medical devices. 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.
NMPA to Strengthen Supervision of Medical Device Clinical Trial Institutions
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.
Read MoreGuangdong Leads the Way in Real-World Medical Research with Innovative "Guangdong-Hong Kong-Macao Greater Bay Area (GBA) Medical Pass
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.
Read MoreNMPA Announcement on Further Strengthening the Supervision and Management of Medical Device Registrants' Contract Manufacturing
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.
Read MoreNMPA Seeks Feedback on Draft Regulations for Clinical Trial Institutions Supervision
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.
Read MoreNew Chapter in Greater Bay Area Development: Hengqin Guangdong-Macao In-depth Cooperation Zone Implements VAT and Consumption Tax Refund Policies
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.
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