各相关企业：按照《关于发布内蒙古自治区药品挂网规则的通知》（内药采中心字〔2025〕167号）相关要求，现将2025年5月11日至2026年6月10日新增药品集中挂网结果予以公布，各申报企业凭用户名和密码登录药品招采子系统查询。内蒙古自治区医药采购中心2026年7月3日

各有关生产、配送企业：根据《关于做好定点医药机构开展门诊统筹结算服务工作的通知》（内医保办发〔2026〕2号）、《关于做好全区集采药品“三进”工作的通知》（内药采中心字〔2026〕91号）、《关于做好鄂尔多斯市定点零售药店药品网上集中采购工作的通知》（鄂医保发〔2026〕14号）等文件要求，我市定点零售药店有序推行药品网上集中采购工作。现就做好定点零售药店药品集中采购配送供应工作有关要求通知如下。一、药店网采政策要求（一）网采药店范围。已自愿申请开通网上集中采购权限的定点零售药店。我市定点零售药店网采权限按季度常态化受理开通。首批已开通网采药店名单详见附件1。（二）网采药品范围。已开通网采权限的定点零售药店应严格落实网采有关规定，通过“内蒙古医保公共服务平台-招采子系统”采购药品。药店实际采购价格高于“招采子系统”挂网价格的，应通过“招采子系统”线上采购；低于“招采子系统”挂网价格或“招采子系统”没有挂网的，可线下采购并按规定完成报备。（三）集采配备要求。我市定点零售药店集采药品目录不作统一规定，定点零售药店自行选购集采药品品种不少于50种，集采药品目录可按季度动态调整，集采药品销售价格不高于中选价。二、配送工作要求（一）购销合同签订。请各药品配送企业主动与我市网采定点零售药店对接沟通，建立常态化对接机制，加快完成双方首营资质互换，精准核对定点零售药店采购需求并签订购销合同，积极备货，保障药品网上集中采购配送工作稳妥推进。（二）精确配送关系。请各药品配送企业根据实际经营产品情况，认真梳理“招采子系统”配送管理，将不再经营的产品配送关系及时申请“撤废”处理，确保医药机构订单有效响应，减少医药机构无效订单。并根据挂网目录的动态调整和经营授权情况，定期调整配送关系，保证供需稳定。（三）及时响应配送。请各药品配送企业严格落实自治区药品集中采购相关工作要求，全面履行购销协议各项约定。坚持远近结合、城乡联动，统筹做好定点零售药店药品配送保障工作。对定点零售药店采购订单做到及时响应配送，保证配送药品信息与订单一致，落实货票同行；自网上订单确认之日起 72 小时内保质保量完成配送。  （四）药品货款结算。定点零售药店网上集中采购药品货款实行线下回款结算，严格按照供需双方签订的药品购销合同约定的时限、方式及金额及时足额回款，保障供需双方合法权益，维护药品集中采购配送良好秩序。（五）配送考核管理。定点零售药店药品配送情况纳入2026年配送考核管理，按照《关于做好药品和医用耗材集中采购配送管理工作的通知》（内药采中心字〔2026〕105号）要求执行。（六）供应短缺报备。请各药品配送企业要严格落实市场短缺产品报备制度，因生产企业产能不足或其他市场因素导致无法供应情况要及时填写“鄂尔多斯区域药品和医用耗材集中采购供应短缺报备表”（附件2），可随时报送至指定邮箱。（七）意见建议反馈。各药品配送企业要充分认清定点零售药店网上采购工作重要意义，切实抓实药品配送各项工作。如在配送环节存在困难、有相关意见建议，可随时通过指定邮箱报送，我中心将统筹协调妥善处置。联系电话：0477-8125352电子邮箱：eedsyc@163.com附件：1.鄂尔多斯市首批开通网采权限的定点零售药店名单      2.鄂尔多斯区域药品和医用耗材集中采购供应短缺报备表鄂尔多斯市医药采购与基金结算中心2026年7月2日

根据《云南省医疗保障局关于对2025年12月医药商业贿赂涉案企业进行信用评价的函》、《国家医疗保障局办公室关于进一步完善医药价格和招采信用评价制度的通知》（医保办发[2025]10号）等文件要求，按照《医药价格和招采信用评价的操作规范（2025版）》相关程序，对相关已核实医药商业贿赂案涉案企业信用评价工作已完成，医药企业失信行为评级通知于2026年7月3日发出，请以下企业到我中心领取通知：序号企业名称1镇雄县辉华药业有限公司2南通康思源贸易有限公司 请上述企业在2026年7月9日前务必到昆明市高新区科发路269号交易大厦四楼402室领取医药企业失信行为评级通知，逾期不领，后果自负。 联系电话：0871-65330065。云南省政府采购和出让中心 2026年7月3日

　　巴尔特科贸（北京）有限公司报告，巴尔特（Balt Extrusion SAS）识别到HYBRID导丝亲水涂层的性能存在偏差，这种偏差可能导致使用过程中HYBRID导丝和微导管之间的摩擦力增加,该问题主要是与巴尔特制造的 MAGIC1.2F微导管共同使用时发生. 巴尔特技术 BALT EXTRUSION SAS对其生产的微导丝Guidewire（注册或备案号：国械注进20213030208 ）主动召回。召回级别为三级。涉及产品的型号、规格及批次等详细信息见《医疗器械召回事件报告表》。附件：《医疗器械召回事件报告表》

经资料审核，宁夏张氏正骨医院申请的活血化瘀软膏等9个应用传统工艺配制中药制剂品种变更说明书、标签（具体内容详见附件）。变更事项符合《中华人民共和国药品管理法》《中华人民共和国中医药法》及《宁夏回族自治区医疗机构应用传统工艺配制中药制剂备案管理实施细则》等相关规定，决定予以变更备案。特此通告。    附件：医疗机构应用传统工艺配制中药制剂备案变更具体信息列表.wps（http://nxyjj.nx.gov.cn/yp/ggtg_37855/xzxkgsgg/202607/t20260703_5281195.html）                         宁夏回族自治区药品监督管理局                            2026年7月2日 

近日，省药监局印发了《2026年推进市县药品监管能力标准化建设任务清单》，提出13个方面年度重点任务，加大对市县指导力度，共同答好市县药品监管能力标准化建设“考卷”，全力推动我省基层药品安全治理体系和治理能力现代化建设再上新台阶。《任务清单》重点明确了健全风险会商、信息通报、重大案件协同办理等长效机制，提升监管质效；实施药品检查员倍增计划，强化基层专业人才引育；开展跨区域药品检查员交叉检查，夯实全生命周期监管实践能力；推动检验监测能力建设，力争市县药品检验检测能力验证计划参与率100%；强化药械网售监管，探索创新药械网售监测举措；完善县域紧密型医共体药械不良反应（事件）监测体系，推动基层药械警戒工作一体化、规范化、制度化；升级智慧监管体系，深化“互联网+政务”服务，推进市县级药械经营许可电子化。下一步，省药监局将认真落实国家药监局和省委省政府工作部署，以深化药品监管改革为动力，以市县药品监管能力标准化建设为抓手，不断完善药品安全责任体系，持续强化药品安全全链条监管，全力打通药品安全治理“最后一公里”，坚决保障人民群众用药安全。

Delivery Method:VIA Electronic MailReference #:320-26-99Product:DrugsRecipient:Dr. Jack Y. ZhangChief Executive OfficerInternational Medication Systems Limited1886 Santa Anita AvenueSouth El Monte, CA 91733United StatesIssuing Office:Center for Drug Evaluation and Research (CDER)United StatesWarning Letter 320-26-99July 2, 2026Dear Dr. Zhang:The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, International Medication System Limited, FEI 2016148, at 1886 Santa Anita Avenue, South El Monte, from December 9 to 19, 2025.This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211).Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).We reviewed your January 15, 2026, response to our Form FDA 483 in detail.During our inspection, our investigators observed specific violations including, but not limited to, the following.1. Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192).Your firm manufactures active pharmaceutical ingredients and sterile injectable drug products. The sterile injectable products include aseptically filled (b)(4).Your firm failed to conduct adequate investigations. For example, you inadequately investigated multiple too-numerous-to-count (TNTC) microbial findings during the manufacture of epinephrine injection, lot EA038A5. Specifically, a viable air environmental monitoring plate, located next to the (b)(4) in your ISO 5 aseptic filling area, yielded a too-numerous-to-count result with confluent bacterial growth and numerous insect larvae. On the same day, personnel monitoring plates for an individual in the adjacent ISO 7 (b)(4) also yielded TNTC results and contained insect larvae.Your investigation failed to identify a scientifically-supported root cause, instead attributing these exceedingly high environmental monitoring findings to an unsubstantiated hypothesis involving insect infiltration of sealed monitoring plates. Notably, written procedures require inspection of plates before use to ensure they are not contaminated or defective, and also require very strict handling measures following sampling (e.g., (b)(4) bags, sterile tape). The microbiological growth media batch also passed negative control testing. Although your deviation report lacked evidence of defects or sampling error, you assessed the contamination risk as “low” based on overreliance on passing sterility test results, and the quality unit approved the release of epinephrine injection, lot EA038A5.The presence of insect larvae and gross microbial contamination in your aseptic processing area demonstrates a critical failure of your contamination control program. The decision to release a lot manufactured under these conditions also demonstrates that your quality unit failed to exercise its responsibility to ensure drug products are manufactured under appropriate conditions and to reject any lot produced under conditions that compromise its quality.In your response, you reiterate that your investigation concluded the contamination was “post-exposure adventitious contamination external to the filling suite,” based on mostly acceptable environmental monitoring data in other locations that day. Using this rationale, you determined the two environmental contamination events were isolated incidents and the risk to the product was low. You also determined that no corrective actions were needed.Your response is inadequate. Your investigation outcome based on a “post-exposure” hypothesis remains poorly supported by data. The occurrence of two severe contamination events on the same day in adjacent rooms indicates a significant breakdown in contamination control. Additionally, your failure to implement corrective actions reflects a critical deficiency in your investigation and indicates inadequate oversight of the state of control of the aseptic processing operation.We also note that, between March 2021 and March 2026, your firm filed three field alert reports for contamination issues with sterile (b)(4) drug products. Since December 2023, you received over 90 customer complaints, many related to container-closure deficiencies such as glass breakage/vial cracking, (b)(4). Many of your investigations were closed without identifying a root cause.In response to this letter, provide:A comprehensive, third-party assessment of your overall system for investigating deviations, discrepancies, complaints, OOS results, out-of-limit results, and failures. Provide a detailed action plan to remediate this system. Your action plan should include, but not be limited to, significant improvements in investigation competencies, scope determination, root cause evaluation, corrective action and preventive action (CAPA) effectiveness, quality unit oversight, and written procedures. Address how your firm will ensure all phases of investigations are appropriately conducted.A third-party assessment and remediation plan for your CAPA program. Provide a report that evaluates whether the program includes effective root cause analysis, ensures CAPA effectiveness, analyzes investigations trends, improves the CAPA program when needed, implements final quality unit decisions, and is fully supported by executive management.A comprehensive, independent review and update of all field alert reports and customer complaints for drug products within expiry, including scientifically sound root cause analyses, corrective actions implemented, and timelines for completion of the investigations. This review should include, where applicable, re-investigation of all complaints involving potential contamination and container-closure deficiencies. Include documentation of all investigative steps taken, potential root causes considered and those systematically ruled out, and any interim controls or preventive measures implemented. Include your corrective action plan based on this in-depth review and trend analysis.A comprehensive, third-party assessment and remediation plan for your pest control program. The assessment should include, but not be limited to, a review of facility design and maintenance, effectiveness of monitoring program, investigation procedures, historical findings, and personnel training.2. Your firm failed to perform operations within specifically defined areas of adequate size and to have separate or defined areas or such other control systems necessary to prevent contamination or mix-ups in aseptic processing areas. Your firm also failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile and that include validation of all aseptic and sterilization processes (21 CFR 211.42(c)(10) and 21 CFR 211.113(b)).Your firm’s aseptic processing lines and operations were inadequately designed, controlled, and monitored to prevent microbiological contamination.Your firm refers to your aseptic processing lines as restricted access barrier systems (RABS). However, your equipment lacks fundamental design elements of a RABS, including (b)(4). Without this basic feature, as well as other design provisions, your processing lines cannot be categorized as RABS.In addition to (b)(4), RABS include various design elements that are essential for minimizing or eliminating direct gowned personnel interventions ((b)(4) interactions) into the critical (ISO 5) area during batch manufacturing.Your current process requires an operator to stand within a (b)(4) ISO 5 area. The operator manually cuts open numerous (e.g., approximately (b)(4)) stopper bags per batch and transfers stoppers using a (b)(4) scoop. These manually-intensive interventions pose a significant and repeated risk of microbial contamination. Despite the critical nature of this activity, your firm failed to conduct environmental monitoring in this area to evaluate its impact on the aseptic environment. This represents a serious gap in environmental control oversight.Your firm also failed to adequately evaluate unidirectional airflow in the critical area, as the smoke studies conducted were fundamentally flawed. The placement and movement of the wand as well as other factors precluded meaningful assessment of airflow directionality.The design of your aseptic filling line presents inherent contamination risks that are exacerbated by inadequate controls. These conditions are insufficient to ensure robust aseptic production of sterile drug products.In your response, you state that you added a new environmental monitoring location in the (b)(4) area and conducted airflow studies in the ISO 5 (b)(4) area. You claim that operator movement has “no impact to 1st air, maintaining unidirectional airflow and minimal turbulence.” You also propose a long-term plan to upgrade the facility within two years, including upgrading the adjacent (b)(4) to ISO 5.Your response is inadequate. Your proposal does not address the fundamental design flaws of your aseptic processing lines, as the primary contamination risks stem from extensive manual interventions within the ISO 5 processing area itself. Additionally, a long-term plan to upgrade the facility in two years is inadequate because it does not address how you will mitigate the immediate and ongoing risk to product quality posed by your current operations.See FDA’s guidance document Sterile Drug Products Produced by Aseptic Processing—Current Good Manufacturing Practice to help you meet the CGMP requirements when manufacturing sterile drugs using aseptic processing at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/sterile-drug-products-produced-aseptic-processing-current-good-manufacturing-practice.In response to this letter, provide:A comprehensive, independent risk assessment of all contamination hazards with respect to your aseptic processes, equipment, and facilities, including but not limited to:o All human interactions within the ISO 5 area (e.g., risk reduction or elimination of manual interventions wherever possible)o Equipment suitability (e.g., reliability, capability, ergonomics, placement) and sufficient cleanroom spaceo Air quality in the ISO 5 area and surrounding room including, but not limited to, air volume and flowo Facility layouto Personnel flow and material flow – movement throughout all rooms used to conduct and support sterile operations, and all material transfersA detailed remediation plan with timelines to address the findings of the contamination hazards risk assessment. Describe comprehensive improvements to be made to aseptic processing operation design and control at your facility and explain how this CAPA plan will robustly remediate your deficient sterile manufacturing operations. Include comprehensive changes to the design of both your aseptic processing lines and cleanrooms. Also, describe your plans for qualification and validation of your extensively remediated operations.Your CAPA plan to implement routine, vigilant operations management oversight of facilities and equipment. This plan should ensure, among other things, prompt detection of equipment/facilities performance issues, effective execution of repairs, adherence to appropriate preventive maintenance schedules, timely technological upgrades to the equipment/facility infrastructure, and improved systems for ongoing management review. Your plan should also ensure that appropriate actions are taken throughout the company network.A retrospective review and risk assessment for drug product batches within expiry that were manufactured in the affected aseptic processing area. Provide a formal risk assessment evaluating the potential for non-sterility hazards for each batch, along with a report detailing your subsequent actions, such as customer notifications or product recalls.Perform a critical evaluation of airflow unidirectionality in your aseptic process with the assistance of a qualified consultant. Ensure smoke studies are conducted under dynamic conditions with thorough and complete evaluations of aseptic processing line airflow unidirectionality, including the impact of dynamic interactions and aseptic interventions. These thorough smoke studies should be performed after you remediate your aseptic operation and conducted using proper practices (e.g., neutrally buoyant media) to appropriately visualize airflow.3. Your firm failed to use equipment in the manufacture, processing, packing, or holding of drug products that is of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance (21 CFR 211.63).Your (b)(4) system was inadequately designed, monitored, and maintained.You use (b)(4) for cleaning drug manufacturing equipment, and the same system feeds your (b)(4) system. During the inspection, we observed gross contamination in the (b)(4) storage tank feeding the (b)(4) system with interior surfaces coated in dark-colored plaques. Further compounding these concerns, investigators observed that (b)(4) had been repaired with (b)(4) sealant material, and that threaded connections with seal tape were used in place of sanitary fittings. These systems failed to adhere to appropriate (b)(4) system design and maintenance standards.In your response, you identify the observed dark-colored plaques in your (b)(4), non-sterile (b)(4) tank as (b)(4) biofilm, characterizing the contamination as “predictable and environmentally normal.” You add that the (b)(4) tank was (b)(4) allowed transmission of ambient light, which enabled photosynthesis and extensive (b)(4) growth on the tank walls. You assert that there was no impact on the quality of the downstream (b)(4), relying on passing test results to support this claim. The primary corrective action you reported was cleaning the affected tank.Your response is inadequate. Your proposed corrective action of simply cleaning the storage tank is insufficient because it fails to address the fundamental design and maintenance flaws that allowed unchecked (b)(4) growth and gross contamination. A source (b)(4) tank should be designed and maintained to prevent it from becoming a reservoir for biological contamination as the resulting bioburden can potentially overwhelm downstream (b)(4) steps. Furthermore, your rationale of using passing downstream test results to justify the use of a grossly contaminated source tank is not in accord with basic system design and control standards. It is your responsibility to ensure that all equipment used in the manufacture of your drug products is appropriately designed, maintained, and controlled.In response to this letter, provide:A comprehensive third-party assessment of your (b)(4) system design, control, and maintenance.A comprehensive remediation plan for the design, control, and maintenance of the (b)(4) system, including:o A comprehensive evaluation of vulnerabilities of (b)(4) system design and control and summarize all deficiencies found in the system. The summary should, at minimum, describe various system characteristics that were assessed for adequacy (system (b)(4), materials of construction, slope, any identified dead-legs, any stagnant locations, any unsanitary fittings, flow velocity, etc.)o Your interim plans for assuring the quality of your (b)(4) during your remediation.o A validation report for the (b)(4) system obtained after an appropriately designed system has been installed. Include the system validation protocol (installation qualification, operational qualification, and performance qualification), complete test results, and the final validation report.Drug RecallOn March 26, 2026, FDA held a teleconference with you recommending you recall epinephrine injection USP 0.1 mg/mL lot EA038A5 from the U.S. market. On April 1, 2026, you initiated a voluntary recall of epinephrine injection USP 0.1 mg/mL, lot EA038A5, due to lack of sterility assurance. The recall was posted to the FDA’s Enforcement Report website at:https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=219475Quality Unit AuthoritySignificant findings in this letter demonstrate that your firm does not operate an effective quality system in accord with CGMP. In addition to the lack of effective management oversight of your production operations, we found your quality unit is not enabled to exercise proper authority and/or has insufficiently implemented its responsibilities. Executive management should immediately and comprehensively assess your company’s global manufacturing operations to ensure that your systems, processes, and products conform to FDA requirements.Assurance of Sterility – Aseptic ProcessingIt should be noted that a sterility test, while a critical final quality control for all aseptically processed products that purport to be sterile, cannot be solely relied upon as justification to release each drug product batch. The sterility test is only the last in a series of design and control provisions intended to protect the consumer from distribution of an unsafe batch. Finished product testing alone does not establish sterility of all units because contamination is typically episodic and not uniformly distributed. Product contamination may go undetected for substantial periods if your firm is placing too much reliance on the final quality control test for sterility to become aware of a problem in aseptic manufacturing. It should also be noted that any positive sterility test result represents a serious CGMP issue that requires a comprehensive investigation into the cause and extent of the problem and a prompt review of the qualification status of your aseptic process.CGMP Consultant RecommendedBased upon the nature of the violations we identified at your firm, you should engage a consultant qualified as set forth in 21 CFR 211.34 to evaluate your operations and to assist your firm in meeting CGMP requirements. The qualified consultant should also perform a comprehensive six-system audit1 of your entire operation for CGMP compliance and evaluate the completion and efficacy of your corrective actions and preventive actions before you pursue resolution of your firm’s compliance status with FDA.Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management remains responsible for resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance.ConclusionThe violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations.If you are considering an action that is likely to lead to a disruption in the supply of drugs produced at your facility, FDA requests that you contact CDER’s Drug Shortages Staff immediately, at drugshortages@fda.hhs.gov, so that FDA can work with you on the most effective way to bring your operations into compliance with the law. Contacting the Drug Shortages Staff also allows you to meet any obligations you may have to report discontinuances or interruptions in your drug manufacture under 21 U.S.C. 356C(b). This also allows FDA to consider, as soon as possible, what actions, if any, may be needed to avoid shortages and protect the health of patients who depend on your products.Correct any violations promptly. Failure to promptly and adequately address this matter may result in regulatory or legal action without further notice including, without limitation, seizure and injunction. Unresolved violations may also prevent other Federal agencies from awarding contracts.Failure to address violations may also cause FDA to withhold issuance of export certificates. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to address any violations.This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days.2 Specify what you have done to address any violations and to prevent their recurrence. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 2016148 and ATTN: Emily Wu.Sincerely,/S/Francis GodwinDirectorOffice of Manufacturing QualityOffice of ComplianceCenter for Drug Evaluation and Research__________________________1 i.e. Quality System, Facilities & Equipment System, Materials System, Production System, Packaging & Labeling System, and Laboratory Control System per FDA’s guidance document Quality Systems Approach to Pharmaceutical CGMP Regulations.2 Under program enhancements for the Generic Drug User Fee Amendments (GDUFA) reauthorization for fiscal years (FYs) 2023-2027, also known as the GDUFA III Commitment Letter, your facility may be eligible for a Post-Warning Letter Meeting to obtain preliminary feedback from FDA on the adequacy and completeness of your corrective action plans.

豪洛捷（上海）医疗用品有限公司报告，Hologic, Inc.经调查发现，部分 ThinPrep® Genesis™ Processor 自动样本处理及制片机的主控板中个别电子元件配置与已发布设计规范存在差异。经技术、安全性、性能、风险管理、上市后表现及中国法规合规性评估和验证，未发现该差异对产品安全性、有效性、预期性能及持续合规性产生不利影响，受影响产品可继续按照现有说明使用。 为确保客户知悉相关信息，并加强已上市产品质量管理和可追溯控制，豪洛捷（上海）医疗用品有限公司决定对 Hologic, Inc.生产的部分自动样本处理及制片机 ThinPrep® Genesis™ Processor（备案号：国械备20210561号）主动召回。召回级别为三级。本次召回采取客户通知方式实施，不涉及产品退回、更换、维修或停止使用。涉及产品的型号、规格及批次等详细信息见《医疗器械召回事件报告表》。附件：医疗器械召回事件报告表(点击下载)2026年07月02日

沪药监械主召2026-112英特格拉生命科技（上海）有限公司报告，由于涉及产品因现行Omni-Tract®外科牵开器系统IFU中标注的干燥时间为30分钟。经确认，在标准预真空温度与时间参数下，干燥时间显著更长，需延长至90分钟、110分钟或120分钟，具体时间取决于所采用的灭菌循环暴露时间。现就Integra® Omni-Tract®外科牵开器系统现行使用说明书（IFU）中与预真空灭菌干燥时间的相关要求发布纠正通知，以确保Omni-Tract®器械及组件在灭菌过程中得到充分干燥，以满足现行ISO标准要求。 截至目前，未收到任何关于患者受伤害或产品受潮的投诉。 等问题，英特格拉生命科技（上海）有限公司对其生产的腹部手术牵开器 Integra? Omni-Tract? Table Mounted Wishbone? Retractor Systems;腹部手术牵开器 Integra? Omni-Tract? Upper Abdominal Retractor System;腹部手术牵开器 Integra? Omni-Tract? Table Mounted Speed-Tract? Retractor System;骨用牵开器 Integra? Omni-Tract? Table Mounted Femur Elevator System;腹部牵开器（注册证号：国械备20152114号;国械备20160469号;国械备20160558号;国械备20160559号;国械备20181581号）主动召回。召回级别为三级。涉及产品的型号、规格及批次等详细信息见《医疗器械召回事件报告表》。附件：医疗器械召回事件报告表2026年07月02日

　　为加强体外诊断试剂产品注册申报和技术审评指导，国家药监局器审中心组织制修定了《基于高通量测序法的胎儿染色体非整倍体（T21、T18、T13）检测试剂盒注册审查指导原则（2026年修订版）》《葡萄糖-6-磷酸脱氢酶检测试剂注册审查指导原则》2项体外诊断试剂注册审查指导原则，现予发布。特此通告。附件：1. 基于高通量测序法的胎儿染色体非整倍体（T21、T18、T13）检测试剂盒注册审查指导原则（2026年修订版）（下载）　　　　　2. 葡萄糖-6-磷酸脱氢酶检测试剂注册审查指导原则（下载）国家药品监督管理局医疗器械技术审评中心2026年7月2日