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
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 ofSupporting 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 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.
