China NMPA Newsletter – July 2022


2022-08-30

Featured Articles

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 () 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


China Supporting Hong Kong And Macao Medical Device Registrants To Produce Medical Devices In 9 Cities of The Greater Bay Area

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:

Work procedures

BradyKnows elite team has extensive experiences in medical device MAH and localization in China, please contact info@bradyknowsmedical.com for any questions.

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Notice For Basic Principles of Medical Device Safety and Performance Compliance Technical Guide Released

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.

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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:

The priority and support given by the NMPA for innovative medical device:

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.

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