经资料审核，宁夏众友健康医药有限公司变更《药品经营许可证》登记事项，主要负责人由“高玉芝”变更为“金艳丽”质量负责人由“马玲”变更为“高玉芝”。变更事项符合《中华人民共和国药品管理法》《中华人民共和国药品管理法实施条例》及《药品经营和使用质量监督管理办法》等有关规定。特此通告。附件：《药品经营许可证》具体信息列表                       宁夏回族自治区药品监督管理局                              2026年7月1日（此件公开发布）附件《药品经营许可证》具体信息列表证书编号社会信用代码企业名称法定代表人主要负责人质量负责人经营地址仓库地址经营方式经营范围发证日期有效期至发证机关宁BA95100003291640000715068228B宁夏众友健康医药有限公司张秀丽金艳丽高玉芝宁夏银川市兴庆区长城东路301号二层201-207室宁夏回族自治区银川市德胜工业园区富强路16号（委托储运）零售连锁总部中药饮片、中成药、化学药、生物制品（含冷藏药品）***2026年7月1日2029年10月29日宁夏回族自治区药品监督管理局

按照《互联网信息服务管理办法》《互联网药品信息服务管理办法》《互联网药品医疗器械信息服务备案管理规定》等相关规定，宁夏回族自治区药品监督管理局2026年6月共批准药品医疗器械互联网信息服务资格备案企业3家。特此通告。附件：2026年6月批准药品医疗器械互联网信息服务资格备案企业目录                      宁夏回族自治区药品监督管理局                             2026年7月1（此件公开发布）附件2026年6月批准药品医疗器械互联网信息服务资格备案企业目录信息服务证书编号机构名称服务性质法人代表地址和邮编网站域名发证机关有效起始日期有效截止日期网站负责人宁网药械信备字〔2026〕000007号宁夏涵晖视光科技有限公司经营性张兴顺宁夏银川市西夏区贺兰山路与兴洲街交汇处西夏古城6号楼B-113750000瞳多多批发（小程序）张家口（阿里云）宁夏回族自治区药品监督管理局2026年6月3日2031年6月2日朱飞宁网药械信备字〔2026〕000008号银川梧桐谷互联网医院有限公司非经营性乔亚钧宁夏银川市西夏区银川中关村创新中心B座四层B-426 750021梧桐谷互联网医院wutonggu.net47.99.122.94浙江省杭州市萧山区高新七路77号移动萧山信息产业园宁夏回族自治区药品监督管理局2026年6月23日2031年6月22日马伟祥宁网药械信备字〔2026〕000009号宁夏康扬中药材科技有限公司非经营性杨彬琳银川市德胜工业园区富强路12号750200宁夏康扬中药（小程序）nxkyzy.cn39.97.63.81北京市（阿里云）宁夏回族自治区药品监督管理局2026年6月30日2031年6月29日杨彬琳

6月22日，福建省药监局印发《福建省药品零售许可管理指导意见》（以下简称《指导意见》）及药品零售连锁企业许可管理规定、药品零售企业许可管理规定、自助售药机管理规定、便民药柜管理规定等4个附录，旨在进一步统一规范我省药品零售许可管理工作，提升药品零售环节质量管理和药学服务能力，推进药品零售行业高质量发展。《指导意见》围绕全省药品零售的许可审批、质量管控与日常监管作了系统性地规定，明确了从业人员禁业情形、经营场所用房合法性要求、药品零售企业的类型、经营范围的核定方式，以及许可、注销相关要求等，对零售企业的采购渠道、追溯扫码、陈列储存、网络销售、连锁企业“七统一”管理等关键环节提出了强化全过程管控的要求。对药品零售连锁企业，规定直营门店数量应不少于5家，设立配送（仓库）中心的、建筑面积应不少于500平方米，允许未建立配送中心的连锁总部进行委托配送，对批零一体的企业允许其与批发企业共享仓库。允许药品零售连锁企业自建远程处方审核平台，用于所属连锁门店的药学技术人员不在岗期间或非工作时段的补充审方。对药品零售企业，实行差异化的管理规定。区分县城城区与乡镇、连锁门店与单体药店、不同经营类别企业，规定了不同的经营场所面积和药学技术人员配备要求。同时，提出“处方审核人员补充机制”，允许企业聘任具备执业药师资格的兼职人员，在岗执业药师不在时进行补充审核。对自助售药机、便民药柜等售药新业态，明确了设置主体，所有药品零售企业均可在同一区县级行政区域内设置。简化了程序，实行告知承诺制，同时强化事后核查；明确了设置条件，自助售药机、便民药柜均应满足药品按标签、说明书规定的储存条件进行设置和管理；明确了责任主体，药品零售企业对自助售药机、便民药柜的药品质量和安全承担主体责任，并由企业所在地的药监部门加强日常监管。此次《指导意见》及其4个附录的出台，是福建省药监局回应民生关切、促进药品零售行业高质量发展的重要举措。省、市、县三级药品监管部门将在下一步的工作中，持续强化政策宣贯、督促指导和监督检查，确保政策落地见效，推动药品零售行业有序、规范、高质量发展，全方位保障群众用药安全、有效、可及。

庐山百草堂生物制药有限公司（注册地址：江西省九江市都昌县新妙湖大道73号，生产地址：江西省九江市都昌县芙蓉山工业园）因企业自身原因，再次向我局报告停止药品生产活动，停产至2027年6月4日。该公司如需恢复药品生产，应向我局提出申请，并经我局开展GMP符合性检查，符合要求后方可恢复生产。特此公告，请社会各界予以监督。江西省药品监督管理局2026年7月2日

网址：https://mpa.xinjiang.gov.cn/xjyjj/tzgg/202607/60b6b15559a443cbac73ac93b5546cad.shtml

行政处罚信息摘要序号行政处罚决定书文号当事人名称法定代表人姓名违法事实行政处罚内容和法律依据作出行政处罚的行政机关名称和日期1新药监械处罚〔2026〕1 号柳*/未经许可生产第二类医疗器械、生产未经注册的第二类医疗器械（定制式活动义齿）依据《医疗器械监督管理条例》第八十一条第一款，1.没收违法所得 31600元(人民币叁万壹仟陆佰元整);2.没收用于违法生产的工具、设备、原材料等物品;3.并处罚款158675元(人民币壹拾伍万捌仟陆佰柒拾伍元整)。罚没款合计 190275 元(人民币壹拾玖万零贰佰柒拾伍元整)新疆维吾尔自治区药品监督管理局，2026年6月26日2新药监械处罚〔2026〕2 号乌鲁木齐健雅口腔医疗有限责任公司李*出借相关医疗器械许可证件依据《医疗器械监督管理条例》第八十三条第二款，处罚款 85000 元(人民币捌万伍仟元整)。新疆维吾尔自治区药品监督管理局，2026年6月26日

行政相对人名称 扬州市华冠科技发展有限公司 行政相对人类别 法人及非法人组织 统一社会信用代码 9132100079088302XJ 工商注册号 组织机构代码 税务登记号 事业单位证书号 社会组织登记证号 法定代表人 方小萍 法定代表人证件类型 身份证 法定代表人证件号码 321************22 证件类型 证件号码 行政处罚决定书文号 苏药监扬处罚〔2026〕7号 违法行为类型 生产说明书不符合规定的一次性使用湿化鼻氧管的行为违反了《医疗器械说明书和标签管理规定》第十六条第一款、《医疗器械监督管理条例》第三十九条第一款的规定。 违法事实 扬州市华冠科技发展有限公司，生产说明书不符合规定的一次性使用湿化鼻氧管的行为违反了《医疗器械说明书和标签管理规定》第十六条第一款、《医疗器械监督管理条例》第三十九条第一款的规定，根据《医疗器械监督管理条例》第八十八条第二项规定，应予处罚。 处罚依据 根据《医疗器械监督管理条例》第八十八条第二项规定。 处罚类别 没收非法财物；罚款 处罚内容 没收非法财物；处以罚款壹万陆仟元整。 罚款金额（万元） 1.6 没收违法所得没收非法财物的金额（万元） 0.0217 暂扣或吊销证照名称及编号 处罚决定日期 2026/07/02 处罚有效期 2027/01/02 公示截止期 2029/07/02 处罚机关 江苏省药品监督管理局 处罚机关统一社会信用代码 11320000014000394R 数据来源单位 江苏省药品监督管理局 数据来源单位统一社会信用代码 11320000014000394R 备注 公示截止期依据文件：市场监督管理行政处罚信息公示规定。罚款金额已确认。

行政相对人名称 扬州美达康科技发展有限公司 行政相对人类别 法人及非法人组织 统一社会信用代码 913210026649322223 工商注册号 组织机构代码 税务登记号 事业单位证书号 社会组织登记证号 法定代表人 薛志诚 法定代表人证件类型 身份证 法定代表人证件号码 321************15 证件类型 证件号码 行政处罚决定书文号 苏药监扬处罚〔2026〕6号 违法行为类型 生产说明书不符合规定的一次性使用鼻氧管的行为违反了《医疗器械监督管理条例》第三十九条第一款的规定。 违法事实 扬州美达康科技发展有限公司，生产说明书不符合规定的一次性使用鼻氧管的行为违反了《医疗器械监督管理条例》第三十九条第一款的规定，根据《医疗器械监督管理条例》第八十八条第二项规定，应予处罚。 处罚依据 根据《医疗器械监督管理条例》第八十八条第二项规定。 处罚类别 罚款 处罚内容 处以罚款壹万陆仟元整 罚款金额（万元） 1.6 没收违法所得没收非法财物的金额（万元） 暂扣或吊销证照名称及编号 处罚决定日期 2026/07/02 处罚有效期 2027/01/02 公示截止期 2026/10/02 处罚机关 江苏省药品监督管理局 处罚机关统一社会信用代码 11320000014000394R 数据来源单位 江苏省药品监督管理局 数据来源单位统一社会信用代码 11320000014000394R 备注 公示截止期依据文件：市场监督管理行政处罚信息公示规定。罚款金额已确认。

为认真落实省委、省政府关于全面提升全省文旅康养服务品质决策部署，做好旅游旺季医疗器械监管工作，保障广大游客用械安全，近期，省药品监管局立足监管职能，精心部署、靠前督导，组织开展旅游旺季景区景点医疗器械质量安全督导检查。本次检查邀请国家药监局驻局专家指导，抽调业务骨干组成检查组，以“四不两直”方式对景区旅游服务区、景点沿线商铺、自助售卖点位等游客密集、氧气销量集中的经营主体，开展医疗器械质量安全检查，重点检查便携式制氧机、便携式供氧器、医用制氧机及电子血压计、电子体温计、血糖仪、急救包、医用敷料等游客高频使用应急医疗器械。检查聚焦源头管控、全链排查。一是多维排查风险隐患。围绕经营主体、进货源头、经营现场等多维度开展全链条监管核查，逐项核验经营单位备案、许可资质、供货商资质、产品合格证明、进货票据及进销台账，紧盯热销器械、护理用品采购渠道，杜绝来源不清、凭证缺失、台账不完善等，全面检查产品仓储陈列、效期管控等情况，严禁过期、变质产品对外销售，闭环排查消除经营现场各类风险隐患。二是强化自动售械机监管。检查组按照自动售械有关要求，现场为景区自助售械点开展合规指导，逐项核查备案资质、日常运维管理制度落实情况，保障游客能够便捷、安全买到合规应急医疗器械。三是加强宣贯引导。在现场检查中同步开展合规宣讲，向经营企业普及医疗器械经营管理规范、台账登记、风险自查等重点要求，进一步压实企业主体责任、提升合规经营意识，引导营造良好旅游市场经营环境。四是压实属地监管。对各市州属地监管落实成效进行实地核验，梳理监管薄弱环节与突出问题，及时反馈属地监管部门、交办整改事项，进一步压紧压实属地日常监管责任。截止目前，全省各市州市场监管局共开展旅游旺季医疗器械监督检查100余次，出动执法人员500余人次，检查经营使用主体380余家，对发现的问题督促相关经营主体及时整改闭环。下一步，省药品监管局持续加大旅游市场医疗器械质量安全监管力度，常态化排查整治医疗器械经营安全隐患，畅通投诉举报渠道，严厉打击各类违法违规行为，进一步筑牢旅游旺季群众用械安全防线。

Delivery Method:VIA Electronic MailProduct:Medical DevicesRecipient:Jian XuPresidentBMC Medical Co., Ltd.No. 16 Lize RoadRoom 10, 17F Building 4, Huiya PlazaFengtai Qu Beijing Shi, 100073China(b)(6)Issuing Office:Center for Devices and Radiological HealthUnited StatesWARNING LETTERCMS # 725759May 20, 2026Dear Mr. Xu:During an inspection of 3B Medical, Inc. (d.b.a. React Health, Inc.) located at 5475 Rings Road, Dublin, OH 43017 from December 1, 2025 through December 10, 2025, an investigator from the United States Food and Drug Administration (FDA) determined that your firm is the specification developer and 510(k) owner of various ventilator devices that are imported to the United States by 3B Medical, Inc. This includes Auto-Adjusting Positive Airway Pressure (Auto-CPAP or APAP) ventilator devices, intended for the treatment of obstructive sleep apnea in adults, under the brand name of G3X APAP (G4600). Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or function of the body.Unapproved Device ViolationsOur inspection revealed that your G3X APAP devices are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption under section 520(g) of the Act, 21 U.S.C. § 360j(g). The devices are also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because your firm introduced or delivered for introduction into interstate commerce for commercial distribution these devices with significant changes or modifications without submitting a new premarket notification to FDA, as required by section 510(k) of the Act, 21 U.S.C. § 360(k), and 21 CFR 807.81(a)(3). For a device requiring premarket approval, the notification required by section 510(k) is deemed satisfied when a PMA is pending before the agency. [21 CFR 807.81(b)]. The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.Your firm has made significant changes or modifications to the design of the Luna® CPAP and Auto CPAP System which was granted clearance on September 8, 2016 under 510(k) number K153387. The inspection at 3B Medical, Inc. established that you are the design change authority and 510(k) owner of the device. For example, FDA has reviewed your firm’s nP3_Product System Verification Report_G3-2.11.01 and Design change evaluation report, Project code: nP3 for the Luna G3 APAP, Model LG3600, approved on March 12, 2025, which revealed that the firmware/software was updated with additional recognition features, i.e., (1) Flow Limitation, (2) Respiratory Effort-Related Arousals (RERA), and (3) Periodic breathing, to distinguish between central hypopnea and obstructive hypopnea events.Furthermore, the sound abatement system of the cleared Luna APAP devices was modified to ‘(b)(4)’ or ‘(b)(4)’ and a new (b)(4) was added to the cleared Luna APAP device to match the sound reduction as a result of the material change. Additionally, the Printed Circuit Board Assembly (PCBA) includes a new (b)(4) chip compatible with the new algorithm and new data structure master control software. These design modifications to the cleared Luna APAP appear to have given rise to a new model branded as G3X APAP. These changes could significantly affect safety or effectiveness because they are significant changes in the design and materials of these devices. The firmware update introduced new detection algorithms capable of distinguishing between central and obstructive hypopnea events, which affects the accuracy of event classification and the data available to clinicians for evaluating therapy effectiveness and informing future therapy adjustments. The removal of (b)(4) represents a material change to the gas pathway that raises biocompatibility concerns, and when combined with the addition of a new (b)(4), these changes could affect the overall pressure and flow profile of the device, thereby impacting therapy delivery. The addition of a new (b)(4) PCBA chip and updated master control software introduces potential implications for electrical safety and overall device performance. Collectively, these changes represent significant modifications in device design, materials, and software that could significantly affect the safety and effectiveness of the device.FDA’s regulations at 21 CFR 807.81(a)(3)(i) provide that submission of a 510(k) is required for “a change or modification in the device that could significantly affect the safety or effectiveness of the device, e.g., a significant change or modification in design, material, chemical composition, energy source, or manufacturing process.” Thus, the G3X APAP is misbranded under 502(o) because of your failure to submit the required premarket notification for the modifications. FDA requests that your firm cease any activities that result in the misbranding or adulteration of your devices.For further explanation on the need for a new premarket notification, or "510(k)," for changes to the intended use or design affecting safety and effectiveness, consult the guidance document "Deciding When to Submit a 510(k) for a Change to an Existing Device — Guidance for Industry and Food and Drug Administration Staff (fda.gov)." The “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program Guidance for Industry and Food and Drug Administration Staff,” is also recommended for obtaining FDA feedback on the 510(k) submission for the G3 X APAP devices.Correction and Removals ViolationsOur inspection also revealed that your firm’s Luna G3 APAP devices are misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 806 – Medical Devices; Reports of Corrections and Removals.Significant violations include, but are not limited to, the following:1. Failure to submit a Report required by 21 CFR 806.10 to FDA, within 10 working days of initiating the correction or removal. For example: your Luna G3 APAP devices with firmware G3-2.00.76 could cause the Luna G3 APAP device to unexpectedly shut down during use, which causes loss of therapy for patients with obstructive sleep apnea. You communicated with 3B (React Health) in (b)(4) to (b)(4). The action of updating the firmware to G3-2.00.77 is a medical device correction or removal initiated to reduce a risk to health posed by the device or to remedy a violation of the Act caused by the device which may present a risk to health, for which you are required to submit a Report of Correction or Removal to FDA.Your firm has not submitted a Report of Correction or Removal to FDA for the firmware update to G3-2.00.77 as of May 19, 2026.Other federal agencies may take your compliance with the FD&C Act and its implementing regulations into account when considering the award of federal contracts.On February 2, 2024, the FDA issued a final rule amending the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) Regulation under 21 CFR 820 to align more closely with the international consensus standard for Quality Management Systems for medical devices used by many other regulatory authorities around the world. The revised part 820, referred to as the Quality Management System Regulation (QMSR), became effective on February 2, 2026. The inspection of 3B Medical on December 1, 2025 to December 10, 2025 was conducted pursuant to the QS Regulation, which was in effect at the time of the inspection. However, should any corrective actions you propose or implement relate to device current good manufacturing practice (CGMP) requirements, they must be made pursuant to the QMSR requirements in effect as of February 2, 2026. For more information on the QMSR please refer to our frequently asked questions webpage: https://www.fda.gov/medical-devices/quality-system-qs-regulationmedical-device-current-good-manufacturing-practices-cgmp/quality-management-system-regulation-final-rule-amending-quality-system-regulation-frequently-asked.Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to address the noted violations, including an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective action (which must address systemic problems) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Please provide a translation of documentation not in English to facilitate our review. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration as part of your response.Your firm’s response should be sent via email to Gina Brackett, Establishment Assessment Team 1 Assistant Director at CDRHEnforcement@fda.hhs.gov. Please include in the subject line, “CMS Case 725759” when replying. If you have any questions about the contents of this letter, please contact: Sargum Morgan, Compliance Officer at sargum.morgan@fda.hhs.gov.Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of any violations and take prompt actions to address any violations and bring the products into compliance.Sincerely,/S/Barbara A. MarsdenDirectorOffice of Regulatory ProgramsOffice of Product Evaluation and QualityCenter for Devices and Radiological HealthCC:(b)(4), (b)(6)