China's NMPA Reports Five Cases of Illegal Medical Device Sales Online (Batch Six)
On May 31, 2024, the National Medical Products Administration (NMPA) released information about five recent cases of illegal online sales of medical devices. The NMPA has taken stern actions to regulate the online sale of medical devices to protect public health and ensure device safety.
Read MoreNMPA Releases 48 New Guidelines for Medical Device Registration Review
On May 27, 2024, the Center for Medical Device Evaluation (CMDE) of the National Medical Products Administration (NMPA) released 48 new guidelines for the registration review of various medical devices, including electric photography beds. The guidelines cover a wide range of medical device categories, such as diagnostic equipment, therapeutic devices, auxiliary equipment, rehabilitation tools, and in vitro diagnostic reagents. These guidelines aim to standardize the registration process, enhance industry standards, and ensure the safety and effectiveness of medical devices. Detailed guidelines for specific devices, including medical gas alarm systems, air-oxygen blenders, radiotherapy laser positioning devices, and various testing reagents, are provided to support manufacturers in meeting regulatory standards. The full texts of these guidelines are available on the NMPA's official CMDE website.
Read MoreClinical Trial Design Considerations for Single-Port Laparoscopic Surgical Systems for Gynecological Surgery
This article outlines the clinical trial design for assessing the safety and effectiveness of a single-port laparoscopic surgical system in gynecological surgeries. The trial adopts a prospective, single-group design, targeting common high-risk gynecological procedures. Key evaluation metrics include the non-conversion rate and complications graded Clavien-Dindo 3 or higher within 30 days post-operation, alongside secondary endpoints like surgery duration, intraoperative blood loss, patient pain scores, and overall complication rates. With a sample size of 60 cases, determined from expected performance data and dropout rates, the trial covers representative procedures such as radical hysterectomy and comprehensive staging surgery for endometrial cancer. Statistical analysis follows established guidelines to ensure rigorous assessment of the system's efficacy and safety.
Read MoreChina Tightens Medical Device Classification Rules to Enhance Safety and Efficiency
The National Medical Products Administration has issued Announcement No. 59 of 2024 to improve the classification management of medical devices. The announcement details the procedures for classifying medical devices based on regulations and guidelines, focusing on factors like intended use and risks. It covers classification for new devices, uncertain categories, and emergency situations during public health crises. The implementation begins on September 1, 2024, replacing the previous classification notification.
Read MoreRegulatory Requirements for Medical Device Manufacturing and Distribution Under the New IVD Classification Catalogue
The National Medical Products Administration (NMPA) of China has released new guidelines under the "In Vitro Diagnostic Reagent Classification Catalogue" to update the regulatory framework for the manufacturing and distribution of medical devices. These guidelines necessitate that manufacturers and distributors of in vitro diagnostic reagents adhere to specific licensing and registration processes based on the management categories detailed in their product registration certificates. The NMPA has mandated continued use of the classification "Management Category - 6840 In Vitro Diagnostic Reagents" across various scopes of manufacturing and distribution. Additionally, provincial drug regulatory authorities are instructed to facilitate the training and implementation of these new regulations to ensure compliance and enhance the management of medical devices, particularly focusing on in vitro diagnostic reagents. This initiative is part of the NMPA’s broader efforts to streamline and improve regulatory processes within the medical device sector in China.
Read MoreMore Insights into China's Updated Classification Guidelines for In Vitro Diagnostic Reagents
China's NMPA introduced significant updates to the management and classification of in vitro diagnostic reagents. These updates include maintaining the validity of existing registrations approved before this date and requiring new registration applications to comply with a revised classification catalogue. The changes also address category adjustments, where products must re-register under the new or old categories depending on risk level adjustments. Additionally, the NMPA will continue processing renewal and change applications received before the effective date under the old catalogue. Class I in vitro diagnostic reagents have a specific transition period until June 30, 2024, after which they must comply with the new catalogue. These revisions aim to enhance the regulatory framework, ensuring the safety and efficacy of in vitro diagnostic reagents in line with current standards.
Read MoreChina's NMPA Issues New Guidelines for In Vitro Diagnostic Reagent Classification
The National Medical Products Administration (NMPA) of China has released Notification No. 17 of 2024, introducing the "Catalogue of In Vitro Diagnostic Reagent Classification." This initiative is designed to streamline the classification process for in vitro diagnostic reagents as per the "Regulations on the Supervision and Management of Medical Devices" and other related guidelines. The Catalogue delineates the scope and structure of these reagents, excluding those used for legally mandated blood screening and those labeled with radioactive isotopes, and organizes them into a detailed system of 25 first-level and 1,852 second-level categories based on detection targets. It provides a pathway for the management of new products, allowing for direct Class III registration or category determination under the Classification Rules. The notification also specifies the management of various products including culture and cell culture media, and general reagents. Moreover, it announces the repeal of previous related notices, effective January 1, 2025, and highlights the dynamic adjustment of the Catalogue based on ongoing risk analysis and device evaluation. This systematic update aims to ensure regulatory compliance and facilitate the registration and filing processes for in vitro diagnostic reagents.
Read MoreNMPA Approves Registration of 292 Medical Device Products in April 2024
In April 2024, China's National Medical Products Administration (NMPA) approved 292 medical device products, including various innovative devices such as single-use surgical instruments, advanced diagnostic kits, and therapeutic devices from notable companies like Volcano AtheroMed Inc., Integra LifeSciences, and Abbott Medical. These approvals span across domestic and imported devices, highlighting the NMPA's focus on expanding access to advanced medical technologies.
Read MoreRecent Enforcement Actions in China’s Medical Device Sector Highlight Regulatory Compliance
The National Medical Products Administration of China has unveiled six significant cases of regulatory violations within the medical device sector, emphasizing its dedication to enforcing stringent safety and legality standards. These instances involve various infractions, including the production and distribution of unregistered and expired medical devices, discrepancies in manufacturer information, and submission of falsified documents. Notable cases include Shanghai Youya Pharmaceutical Technology Co., Ltd., which faced hefty fines and confiscation of illegal gains for unauthorized production, and Chongqing Hexi Medical Beauty Clinic, which incurred a major penalty for using non-compliant Class III medical devices. These actions reflect China's proactive approach to ensuring compliance in the medical device industry, aiming to safeguard public health through rigorous regulatory oversight.
Read MoreExploring the Role of Commercial Insurance in Facilitating Access to Innovative Medical Products in China
Commercial insurance is playing a pivotal role in advancing healthcare access in China, particularly in regions like Hainan and the Greater Bay Area. By covering high costs associated with innovative medical products, insurance is making these treatments more accessible and affordable for patients. This not only aids in quick market entry and expansion for international medical products but also aligns with China's healthcare policies promoting innovation. In areas like the Boao Lecheng International Medical Tourism Pilot Zone in Hainan and the Greater Bay Area, commercial insurance is fostering the creation of international medical hubs, enhancing patient care, and facilitating the integration of cutting-edge medical technologies. This strategic use of insurance supports the broader vision of a modernized, patient-centered healthcare system in China.
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