NMPA Cancels 31 Medical Device Registration Certificates on July 1, 2026

Summary

On July 1, 2026, the National Medical Products Administration (NMPA) announced that, in accordance with the Regulations on the Supervision and Administration of Medical Devices and upon application by the companies, it had cancelled 31 medical device registration certificates held by 14 companies. The products involved include electronic stethoscopes, phototherapy units, Mycoplasma pneumoniae detection kits, patient monitors, bone screws, guidewires and other devices. Companies should monitor changes in registration status and promptly handle inventory, labels and market activities for cancelled products to avoid compliance risks.

Source and Applicability

Source organization: NMPA Medical Devices

Original announcement date: June 29, 2026

NMPA publication date: July 1, 2026

AIMEILI publication time: July 9, 2026, 15:00

Source: NMPA Medical Devices, https://www.nmpa.gov.cn/xxgk/ggtg/ylqxggtg/ylqxqtggtg/20260701104619178.html

This article is prepared from publicly available NMPA Medical Devices information. Specific requirements are subject to the latest official release by the regulatory authority.

Full Translation of the NMPA Announcement

In accordance with the relevant provisions of the Regulations on the Supervision and Administration of Medical Devices, and upon application by the companies, the National Medical Products Administration has cancelled the medical device registration certificates of the following 31 products from 14 companies:

• 1. Tyto Care Ltd. (泰妥医疗有限公司): one product, Electronic Stethoscope Tyto Stethoscope, registration certificate No. 国械注进20222070544.
• 2. Lutronic Corporation ((株)路创丽公司): one product, Phototherapy Unit, registration certificate No. 国械注进20172097215.
• 3. Shanxi Kangbao Biological Technology Co., Ltd. (山西康宝生物科技有限公司): one product, Mycoplasma pneumoniae IgM Antibody Detection Kit (enzyme-linked immunoassay-capture method), registration certificate No. 国械注准20153402137.
• 4. DiaSorin Inc. (索灵诊断（美国）有限公司): one product, Herpes Simplex Virus Type 1 IgG Antibody Quality Control Material LIAISON® Control HSV-1 IgG, registration certificate No. 国械注进20173402194.
• 5. Hanil T&M Co., Ltd. (주식회사 한일티엠): two products, Microwave Therapy Device 극초담파 자극기, registration certificate No. 国械注进20223090487; Shockwave Therapy Device, registration certificate No. 国械注进20222090333.
• 6. KARL STORZ SE & Co. KG (卡尔史托斯公司): six products, Video Bronchoscopes (电子支气管内窥镜), registration certificate No. 国械注进20142065496; Portable Anesthesia Laryngoscope Imaging System C-MAC Video-oropharynx Laryngoscope Imaging System, registration certificate No. 国械注进20152060617; C-MAC S Video Laryngoscope (Electronic Anesthesia Laryngoscope), registration certificate No. 国械注进20142065828; The Mobile Compact Solution (Endoscope Image Display Device), registration certificate No. 国械注进20152061295; Anesthesia Fiberscope Systems (纤维气管插管内窥镜), registration certificate No. 国械注进20142066057; Retromolar Intubation Endoscopes (半硬性气管插管镜), registration certificate No. 国械注进20142065822.
• 7. Avanos Medical, Inc. (爱诺生医疗股份有限公司): one product, Powered Inflatable Tube Massager (加压冷疗系统), registration certificate No. 国械注进20192090386.
• 8. Guangdong Biolight Meditech Co., Ltd. (广东宝莱特医用科技股份有限公司): four products, Patient Monitors, registration certificate Nos. 国械注准20173074623; 国械注准20153070227; 国械注准20173074618; 国械注准20173074624.
• 9. Shenyang Dongya Medical Research Institute Co., Ltd. (沈阳东亚医疗研究所有限公司): one product, Track-Toothed Arch-Type Compression Bone Plate (轨道齿式拱型加压接骨钢板), registration certificate No. 国械注准20163132022.
• 10. Mediox Orvosi Műszergyártó Kft. (匈牙利迈迪奥有限公司): three products, Cannulated Screw, registration certificate No. 国械注进20163132784; Locking Plate System (Metal Straight Locking Bone Plate System), registration certificate No. 国械注进20163131691; Metal Bone Screw, registration certificate No. 国械注进20163132872.
• 11. Foshan Qiyou Medical Technology Co., Ltd. (佛山市其右医疗科技有限公司): five products, Peripheral Vascular Guidewire, registration certificate No. 国械注准20223030164; Guiding Wire, registration certificate No. 国械注准20223031448; Neurovascular Guidewire, registration certificate No. 国械注准20223031519; Guiding Wire, registration certificate No. 国械注准20223031687; Hydrophilic Coated Guidewire, registration certificate No. 国械注准20233030594.
• 12. Baonan Biotech Co., Ltd. (宝楠生技股份有限公司): one product, Posterior Spinal Screw-Rod System (先鋒脊椎內固定系統、先鋒脊椎固定系統), registration certificate No. 国械注许20173130048.
• 13. Zeon Medical Inc. (瑞翁医疗株式会社 / ゼオンメディカル株式会社): three products, Stone Retrieval/Lithotripsy Basket ゼメックス クラッシャーカテーテルＭ, registration certificate No. 国械注进20252020201; Biliary Dilation Catheter ＥＳダイレータ, registration certificate No. 国械注进20242020235; Single-Use Sterile Gastrointestinal Traction Clip けん引クリップ, registration certificate No. 国械注进20242020493.
• 14. ConvaTec Inc. (康维德股份有限公司): one product, Advanced Pouches System (ostomy bag), registration certificate No. 国械注进20172146259.

Hereby announced.

National Medical Products Administration

June 29, 2026

AIMEILI Regulatory Interpretation and Business Impact

The NMPA cancellation of 31 medical device registration certificates in a single announcement involves 14 domestic and foreign companies and covers electronic endoscopes, therapeutic devices, in vitro diagnostic reagents, orthopedic implants, vascular guidewires, ostomy pouches and other categories. From an international regulatory consulting perspective, the key implications for medical device companies are as follows.

1. Loss of lawful market access

Cancellation of a registration certificate means that the product loses its legal basis for marketing in China. Registrants of cancelled products should immediately stop manufacturing, importing, selling and using the affected products and should complete inventory disposal, label replacement, market recall and other follow-up actions in accordance with the Regulations on the Supervision and Administration of Medical Devices. For imported products, the designated domestic agent should coordinate with the overseas manufacturer on the China market exit process; failure to do so may result in administrative penalties.

2. Voluntary cancellation versus regulatory revocation

All cancellations in this announcement were initiated by the companies rather than imposed by the regulator. This indicates that voluntary cancellation is a compliant exit route when a product’s commercial strategy changes, technology is updated or the product no longer meets current standards. However, for certificates still within their validity period, companies should continuously monitor regulatory changes, such as the new GB 9706 series standards and adjustments to IVD classification, to avoid passive cancellation because products cannot meet new requirements.

3. Technical documentation management

Technical materials for cancelled products, such as product technical requirements, clinical evaluation reports and quality management system documents, should still be retained in accordance with records management rules, generally for at least two years after the expiry of the registration certificate. Companies planning to re-register or change a product should note that the original registration certificate number is no longer valid, and a new application should be submitted under the initial registration pathway or another applicable registration pathway.

4. Clinical evaluation and performance verification

The cancellation of several products, such as electronic stethoscopes, phototherapy units and Mycoplasma pneumoniae detection kits, highlights the need to carefully assess the continued validity of clinical data. For example, if a product’s clinical evaluation relies on comparison with a predicate device and that predicate device has been cancelled, the company should select a new comparator or supplement clinical trial data.

5. Labeling and instructions for use updates

Inventory labels and instructions for use for cancelled products must not continue to be used. Products already in circulation should be recalled or relabeled within the required period. For other products sold by the same company, care should be taken to avoid confusion with cancelled products, especially where products belong to the same series or share similar registration certificate number prefixes.

6. Post-market maintenance and complaint handling

Even after a product is cancelled, the company remains responsible for adverse event monitoring and complaint handling for products already sold. Companies should establish after-sales traceability mechanisms for cancelled products to ensure that customer requests can be addressed within a reasonable period.

7. Implications for foreign companies entering China

The cancellation list also provides a cautionary example for foreign companies planning to enter the China market. Some companies, such as KARL STORZ and Zeon Medical, cancelled multiple products, possibly due to product line adjustments or compliance costs. New entrants should fully assess the long-term maintenance costs of China registration, including changes, renewal, quality management system audits and post-market obligations, to avoid certificate invalidation due to insufficient resources.

Business impact for manufacturers, distributors, CROs and regulatory teams

• Manufacturers: review the registration status of the affected products, stop related production and import activities, and arrange inventory, labeling and recall actions.
• Distributors: verify whether stock on hand involves cancelled certificates and suspend sales or distribution activities for affected products unless otherwise permitted.
• CROs and regulatory teams: check whether comparator devices, clinical evaluation strategies or registration plans rely on any cancelled product or certificate.
• Regulatory affairs teams: monitor certificate validity, standards updates and classification changes, and maintain a product portfolio review process.

Overall, registration certificate cancellation is an important part of the medical device lifecycle management. Chinese medical device companies should use this announcement as a reference, regularly review their product portfolios, proactively phase out non-compliant or low-value products, and strengthen registration status monitoring to ensure that commercial activities remain within the legal framework.

FAQ

Can the July 1, 2026 NMPA cancellation list be used directly as a basis for a regulatory submission?

No. This article is intended for preliminary understanding and project assessment. Formal submissions must be based on the latest requirements of the target country regulator, the product classification conclusion and the company’s actual documentation.

What should companies do first after seeing this update?

Companies should first conduct a documentation gap assessment to determine whether the update affects the registration pathway, technical file, labeling, quality management system or post-market maintenance obligations.