In September 2022, NMPA approved 222 medical devices, including 24 Class III imported products, 33 Class II imported products, and 163 Class III domestic products.
Below is a list of approved Class III and Class II imported products in September, 2022.
Medical Device/IVD
Manufacturer
Category
Captivator Cold Single-Use Polypectomy Snare
Boston Scientific Corporation
Class III
Air Optix Plus Hydraglyde For Astigmatism Soft Contact Lens
Alcon Laboratories, Inc.
Class III
Cranial Fixation Sterile Set
Rebstock Instruments GmbH
Class III
Diagnostic Ultrasound System
Siemens Medical Solutions
USA, Inc.
Class III
Radiation Treatment Planning System
Elekta Solutions AB
Class III
Patient Monitor
Philips Medizin Systeme
Böblingen GmbH
Class III
OMNIset TPE
B.Braun Avitum AG
Class III
Dental Implant
Nobel Biocare AB
Class III
SURGICEL FIBRILLAR Absorbable Hemostat
Ethicon, LLC
Class III
Guidewires
日本ライフライン株式会社
Class III
Legion System and Accessories
Alcon Laboratories, Inc.
Class III
ArthroCare ENT Plasma Wands
ArthroCare Corporation
Class III
LIAISON® XL murex HCV Ab
DiaSorin S.p.A.
Class III
Idylla™ System
Biocartis NV
Class III
Lasersystem for assisted reproduction
Vitrolife GmbH
Class III
Ennovate Spinal System Implants
Aesculap AG
Class III
Titanium Suture Anchor
Arthrex,Inc.
Class III
AQUACEL® Foam Pro Dressing
ConvaTec Limited
Class III
Soft hydrophilic contact lens
株式会社メニコン
Class III
HD-Tubing systems Accessories
Fresenius Medical Care AG
& Co. KGaA
Class III
Computed tomography x-ray system
GE MEDICAL SYSTEMS,LLC
Class III
VNS Therapy System
LivaNova USA, Inc.
Class III
Surgical Microscope
Carl Zeiss Meditec AG
Class III
BIOSURE REGENESORB Interference Screw
Smith & Nephew Inc.,
Endoscopy Division
Class III
Tracheostomy Tube
Covidien llc
Class II
Lens Fragmentation Device
Carl Zeiss Meditec AG
Class II
GARDIAN TM 25 mm SYRINGE FILTERS
Pall Medical, a Division of
Pall International Sàrl
Class II
Dental Ceramics
Institut Straumann AG
Class II
Stat Profile Prime Plus Auto QC Cartridge
Nova Biomedical Corporation
Class II
VITEK 2 AST-YS08
BIOMERIEUX S.A.
Class II
Stimulator for Functional Electrical Stimulation
HASOMED GmbH
Class II
Body Composition Analyzer
InBody Co., Ltd.
Class II
Insufflator
Aesculap AG
Class II
Hawkins Breast Localization Needle
Argon Medical Devices, Inc.
Class II
Minivette® POCT
SARSTEDT AG & Co. KG
Class II
Hawkins Breast Localization Needle
Argon Medical Devices, Inc.
Class II
Angel of Water Colon Hydrotherapy System
Lifestream purification
Systems, LLC
Class II
qUAntify Plus Control
Bio-Rad Laboratories, Inc.
Class II
Erythropoietin (EPO)
Siemens Healthcare
Diagnostics Inc.
Class II
Medical Image Processing Software
Vital Images, Inc.
Class II
Looking Glass 4K Integrated Visualization System
ConMed Corporation
Class II
EV3.0 Camera Control Unit
Aesculap AG
Class II
EEG recorder
lifelines Ltd.
Class II
Medical cooling therapeutics
日本シグマックス株式会社
Class II
Stat Profile Prime Plus Calibrator Cartridge
Nova Biomedical Corporation
Class II
CalSet Vitamin D total III
Roche Diagnostics GmbH
Class II
PreciControl Vitamin D total II
Roche Diagnostics GmbH
Class II
Videocolposcope
Karl Kaps GmbH & Co. KG
Class II
Fundus Camera
Natus Medical Incorporated
DBA Excel-Tech Ltd.(XLTEK)
Class II
Autorefractometer
株式会社ニデック
Class II
GIA stapler and cartridge with Tri-Staple technology
On August 31, NMPA released a notice on the issue of Filing Examination Requirements for Medical Device Registration and other Documents (NMPA Notice No. 40 of 2022). According to the notice, the trial requirements issued with NMPA Notice No.42 of 2019 have been revised and the new requirements will be implemented from the date of release.
This revision involves a wide range of NMPA filing examination work, with 11 new requirements totaling 170 pages issued together with the notice.
For example, according to the newly released Filing Examination Requirement for Medical Device Registration, clinical evaluation will be completed by staff of NMPA’s Clinical and Biostatistics Department, instead of personnel from its Review Department or Clinical and Biostatistics Department as specified in the 2019 trial requirements. Besides, the basic review question has also been changed from “Is it definite that the product can be regulated as medical device?” to “Is it definite that the product can be regulated as medical device or the device-dominant combo product?”
BradyKnows elite team has rich experience in helping overseas clients to overcome challenges during China registration. If you have any questions on China market, please contact info@bradyknowsmedical.com.
In order to do a good job of quality management system audit under medical device MAH (Market Authorization Holder) system and improve the QMS audit quality for medical device registration, NMPA issued Guidelines for Quality Management System Audit of Medical Device Registration (NMPA, No. 50, 2022) on October 10, 2022.
This guideline is applicable to the on-site audit of the quality management system for Class II and Class III medical device registration carried out by the medical device regulatory authorities.
This guideline has a total of 73 audit items, of which 32 are marked with “*” key items and 41 general items.
It covers the key contents of quality management system, registration audit requirements, self-test audit requirements, etc. At the same time the quality management system principles, institutions and personnel, plant, facilities and equipment, document management, design and development, procurement, production, quality control, commissioned production and product authenticity as the key contents of the audit are explained in details.
Compared with the 2020 version, this version has added GMP, GCP and self-test provisions, clarifies the requirements for commissioned production and clinical, and revises and removes some of the content for easier execution.
BradyKnows elite team has rich experience in medical device quality management system audit, covering ISO 13485, FDA 21 CFR 820, ISO 11135, NMPA GMP etc. If you have any questions about the audit in China and NMPA overseas audit, please contact info@bradyknowsmedical.com.
On Sep 26, 2022, NMPA approved the registration application of the innovative device “Proton Therapy System” produced by Shanghai APACTRON Particle Equipment Co., Ltd.
Consisting of the accelerator system and the therapy system, this device provides proton beams for radiotherapy. It is designed for the treatment of malignant solid tumors and certain benign diseases. Specific indications should be determined by clinicians according to the actual situation.
China has provided fast-track approvals for innovative medical devices. About 178 domestic and foreign innovative medical devices have been approved so far. The approval of the “Proton Therapy System” marks a new step in the localization of high-end medical devices in China and improves tumor diagnosis and treatment.
BradyKnows elite team provides turnkey solutions to innovative manufacturers from R&D, China entry strategy, registration, clinical evaluation and post-market surveillance.
If you have any questions on innovative pathway, please contact info@bradyknowsmedical.com. We would love to do more help on your China business.
Wednesday, November 2, 2022, 7:00am-8:00am(PDT), 10:00am-11:00am(EDT) (US and Canada)
Wednesday, November 2, 2022, 4:00pm-5:00pm CET (Europe)
Wednesday, November 2, 2022, 10:00pm-11:00pm(Beijing Time)
Since the release of “Made in China 2025” by the State Council of China in 2015, the localization of domestic medical devices is becoming a general trend. In recent years, the state has continuously introduced policies to encourage and support domestic substitution of medical devices.
In April 2022, the Anhui province issued the Circular on Regulation Government Procurement of Imported Products by Public Medical Institutions, which prohibits all public medical institutions from purchasing imported products without approval. Since 2021, Zhejiang, Guangdong, Sichuan, and Shanxi Provinces have successively released the latest “Imported Medical Device Procurement List” to tighten the product type and quantity of imported medical devices. From encouraging to prioritizing domestic production, and now purchasing domestic medical devices, these policies have provided a more favorable competitive environment for domestic products.
For a long time, imported medical devices have occupied a leading position in the Chinese market, especially for high-end products. However, in most low-end markets, price and patient affordability remain decisive. International companies still face price-based simple competition, especially under the preference and protection of domestic production. To better develop the economical market, some companies decided to switch to local production.
As a leading consulting company for China’s medical device market entry, BradyKnows Medical has helped many international companies to develop China’s localization strategies to ensure their regulatory compliance with the local authorities. In this webinar, the agenda includes:
Agenda:
Introduction of China localization of medical devices
Key policies supporting medical device localization in China
