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 MoreNMPA Announces Results of National Medical Device Supervision and Inspection (Announcement No. 42 of 2024)
The National Medical Products Administration conducted a national inspection on 7 categories of medical devices, finding 11 batches/units that did not meet quality standards, including issues with ultrasound therapy equipment, high-frequency electrosurgical units, nebulizers, limb compression therapy equipment, dental cements, and dental products. The administration has ordered provincial authorities to take enforcement actions, require the manufacturers to assess risks, recall the non-compliant products, investigate the causes, and implement corrective measures.
China 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.
China's NMPA Releases Updated Guidelines for Class III Ultrasound Imaging Devices
China's NMPA has released updated guidelines for Class III ultrasound imaging devices. Announced on October 14, 2024, the revised document aims to standardize management of these medical devices. It covers registration requirements, safety standards, software validation, and clinical applications. The guidelines reflect current regulations and technological advancements, serving as a resource for manufacturers and reviewers.
China's NMPA Announces 34 New Medical Device Industry Standards
China's National Medical Products Administration announced 34 new medical device industry standards on October 8, 2024. These standards cover various areas including dental materials, blood purification equipment, ophthalmology instruments, surgical implants, AI in medical devices, robotic surgical systems, genetic testing kits, and tissue engineering materials. The standards aim to regulate performance, safety, and quality requirements, reflecting technological advancements in China's medical device industry. Implementation dates range from 2025 to 2027.
China's NMPA Announces Results of Medical Device Quality Inspection (Notice No. 35 of 2024)
The National Medical Products Administration (NMPA) of China has released the results of its latest quality inspection of medical devices. The inspection, covering 17 categories of products, found 24 batches (units) that failed to meet the required standards on September 12, 2024.
Read MoreNMPA 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 MoreChina'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.
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