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NMPA New Approvals In July 2022
In July 2022, NMPA approved 197 medical devices, including 20 Class III imported products, 22 Class II imported products, and 152 Class III domestic products.
Below is a list of approved Class III and Class II imported products in July, 2022.
Medical Device/IVD | Manufacturer | Category |
Breast Implant | Mentor | Class III |
Vascular Stent Graft | Angiomed GmbH & Co. Medizintechnik KG | Class III |
Medical X-ray angiography equipment | GE MEDICAL SYSTEMS SCS | Class III |
Hemodynamic and Electrophysiological Recording System | Siemens Healthcare GmbH | Class III |
Cochlear implant | Advanced Bionics AG | Class III |
Biodentine | SEPTODONT | Class III |
Sterile siliconised needles | SEPTODONT | Class III |
Ophthalmic Photocoagulator | Lumenis Inc. | Class III |
Ear nose X-ray cone beam tomography equipment | Xoran Europe D.o.o | Class III |
Catheter sheath system | 東郷メディキット株式会社 | Class III |
Hip Joint Prostheses-Acetabular Liner | Zimmer Inc. | Class III |
Hip Joint Prostheses-Acetabular Liner | Zimmer Inc. | Class III |
Hydrophilic coated guide catheter | PendraCare International B.V. | Class III |
Semiconductor laser hair remover | Formatk Systems Ltd. | Class III |
Implantable Pacemaker | Medtronic Inc. | Class III |
Syringe kits for drug mixing | MEDEX | Class III |
Special needle for disposable implantable drug delivery device | pfm medical cpp SA | Class III |
Double curing resin cement | VERICOM CO., LTD. | Class III |
Ureteral stents and sets | Urotech GmbH | Class III |
Implantable deep brain nerve stimulator | Medtronic Inc. | Class III |
Small Bone Powered Surgical Systems | Stryker Instruments | Class II |
Disposable electronic bronchoscope | Ambu A/S | Class II |
Digital mobile photographic X-ray machine | 富士フイルム株式会社 | Class II |
Shock wave therapeutic apparatus | (주) 한일 티엠 | Class II |
Creatinine and urea nitrogen electrodes | Nova Biomedical Corporation | Class II |
Disposable heated breathing tube | Drägerwerk AG & Co. KGaA | Class II |
Body composition analyzer | AKERN SRL | Class II |
EEA Circular Stapler with Tri-Staple Technology | Covidien llc | Class II |
Disposable Foley Catheters | ConvaTec Limited | Class II |
Disposable Trocar | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | Class II |
Electric peeling machine | Aesculap AG | Class II |
Lower limb medical rehabilitation training apparatus | ArjoHuntleigh AB | Class II |
Monitoring information management software | Philips Medizin Systeme Böblingen GmbH | Class II |
Seawater nasal spray | Jadran-Galenski laboratorij d.d. | Class II |
Puncture instrument and accessories for laparoscope | AMNOTEC International Medical GmbH | Class II |
Ultrasonic scaler | SATELEC A Company of ACTEON Group | Class II |
Multiconstituent Calibrator | Siemens Healthcare Diagnostics Inc. | Class II |
Dental diaphragms | Bay Materials LLC | Class II |
Drills | WARANTEC CO., Ltd. | Class II |
Multi-test control | Bio-Rad Laboratories, Inc. | Class II |
Embryo incubator | Planer Limited | Class II |
Infusion pump | AMPALL CO.,Ltd | Class II |
Sources: NMPA
To promote the reform of the medical device registrant system (Market Authorization Holder,MAH for short) in the Guangdong – Hong Kong – Macao Greater Bay Area, Implementation Plan of Supporting Hong Kong And Macao Medical Device Registrants To Produce Medical Devices In 9 Cities of The Greater Bay Area was issued on June 29, 2022.
The Greater Bay Area – with a total population of approximately 78 million people – includes nine mega cities of Guangdong province: Guangzhou, Shenzhen, Zhuhai, Foshan, Dongguan, Zhongshan, Jiangmen, Huizhou, and Zhaoqing.
Scope of application:
- Product scope: Applicable to the medical devices that are held and produced by enterprises legally registered in Hong Kong Special Administrative Region or Macao Special Administrative Region and have been registered for market in China with the Medical Device Registration Certificate.
- Applicable enterprises: If the medical device registrant is a Hong Kong or Macao enterprise, the legal person of a foreign-invested enterprise established in the Greater Bay Area shall act as an agent to handle the registration of medical device changes, assist the Hong Kong and Macao medical device registrants to perform their obligations and assume relevant responsibilities.
Work procedures
- Identify domestic agent;
- Sign the commissioned production agreement;
- Change the manufacturing address of the medical device registration certificate;
- The entrusted production enterprise fulfills its reporting obligations.
BradyKnows elite team has extensive experiences in medical device MAH and localization in China, please contact info@bradyknowsmedical.com for any questions.
On July 13, 2022, CMDE of NMPA issued a notice of the Compliance Technical Guideline of Essential Principles of Medical Device Safety and Performance (hereinafter referred to as the “Essential Principles”).
The Essential Principles is the basic requirements for the safety and effectiveness of medical devices based on risk. The applicant for registration should consciously fulfill the main responsibility to integrate the requirements of the Essential Principles into the development and manufacturing process of medical devices, under the control of the quality management system to form the corresponding evidence of compliance, submitted as proof of product safety and effectiveness during registration.
BradyKnows can help guide applicants to register filing in a scientific and reasonable manner. If you have any questions on medical device registration, please contact info@bradyknowsmedical.com.
NMPA Notice On Special Review Procedures Of Innovative Medical Devices
NMPA published Special Review Procedures Of Innovative Medical Devices on November 5, 2018. The implementation of this procedure has played a positive role in promoting medical device R&D innovation, the promotion and application of new technologies, and the high-quality development of the industry.
Innovative medical devices should meet the following requirements:
- Applicant owns the patent rights of product core technology in China according to the law or acquires legal right to use in China;
- Applicant has completed the preliminary research of the product and has a product prototype. The research process is authentic and controlled, and the research data is complete and traceable;
- The main working principle or mechanism is pioneering in China, the performance or safety of the product is fundamentally improved compared with similar products, and is technically at the international advanced level with significant clinical value.
The priority and support given by the NMPA for innovative medical device:
- Special personnel from the NMPA provides support with innovative medical devices to speed up the registration procedures;
- Priority testing of innovative devices and issuance of testing reports;
- Priority for technical review of innovative medical devices, NMPA priority for their administrative approval;
- Approved by the review process of registration of medical devices to apply for changes in licensing matters, the NAPA is also given priority;
- Applicants can fill out the application form for communication of innovative medical devices before the registration application is accepted and during the technical review process, and communicate with CMDE on major technical issues, major safety issues, clinical trial protocols, summary and evaluation of phase clinical trial results, and other important issues that require communication.
To sum up, Special Review Procedures Of Innovative Medical Devices opens up a green channel for the registration of innovative medical devices. BradyKnows has helped many medical device manufacturers apply for the NMPA registration via the innovative medical device pathway. For more questions related to Special Review Procedures Of Innovative Medical Devices, please contact info@bradyknowsmedical.com.
Resources – Webinar
Please click here to review the record of BradyKnows webinar.
- Medical Device Real World Evidence (RWE) In China: Policies, Usage, Study Plan, Case Study
- China Regulatory Updates Of Q1/2022 & Tips For Medical Device Registration Under Covid
- How To Increase The Likelihood Of China CER Approval?
- Keep Up With The Enhancement Of Medical Device Post-Market Surveillance In China: GMP, GSP, And NMPA Onsite Inspections
Resources – Documents Download
- Registration Review Guideline Of The Requirements For Submission Of Clinical Trial Data Of Medical Devices (November 25,2021)
- Guideline For The Registration Review Of Artificial Intelligent Medical Device (March 7, 2022)