In July 2023, NMPA approved 197 medical devices, including 21 Class III imported products, 21 Class II imported products, and 150 Class III domestic products. Below is a list of approved Class III and Class II imported products in July 2023.
Medical Device/IVD
Manufacturer
Category
Dental Implant
Dentis Co.,Ltd.
Class III
Dual Mobility Vivacit-E Polyethylene Hip Bearing
Zimmer Inc.
Class III
Clearlab eyedia multi-purpose solution
Clearlab SG Pte. Ltd.
Class III
NovaSure Impedance Controlled Endometrial Ablation System
Hologic, Inc.
Class III
Endoskeleton TCS Interbody System
Medtronic Sofamor Danek USA, Inc.
Class III
Adaptix™ Interbody System with Titan nanoLOCK™ Surface Technology
Medtronic Sofamor Danek USA, Inc.
Class III
Persona Trabecular Metal Knee System
Zimmer Inc.
Class III
SP-CL Hip Stem Prosthesis
Waldemar Link GmbH & Co.KG
Class III
CP-Monitor
Spiegelberg(GmbH&Co)KG
Class III
Opalescence Endo Endodontic Whitening System
Ultradent Products, Inc.
Class III
ROSA Recon Platform
Zimmer CAS
Class III
Comprehensive Reverse Shoulder System
Zimmer Inc.
Class III
Medical System for Ultrasound Diagnosis
Compumedics Germany GmbH
Class III
NeuroSpeed PTA Balloon Catheter
Acandis GmbH
Class III
AcrySof™ IQ Vivity™ Toric Extended Vision IOL
Alcon Laboratories, Incorporated
Class III
Self-curing general purpose adhesive for dental gum adhesives
株式会社トクヤマデンタル
Class III
Holmium (Ho:YAG) laser therapy machine
Lumenis Limited
Class III
Ozone Generators
Dr.J.Hansler GmbH
Class III
Infusion Syringe Pump
B. Braun Melsungen AG
Class III
Diacan Flex
B.Braun Avitum AG
Class III
Preloaded System Intraocular Lens
HOYA Medical Singapore Pte. Ltd.
Class III
Surgical Saw Blade
Zimmer Surgical, Inc.
Class II
DAMON Q2 SINGLE PATIENT KIT
Ormco Corporation
Class II
Sterile Nitrile Examination Glove
Hartalega Sdn. Bhd.
Class II
Metal Self-ligating bracket
American Orthodontics
Class II
MicroScan Pos Combo Panel Type 44
Beckman Coulter, Inc.
Class II
Tina-quant Soluble Transferrin Receptor II（STFR2）
Roche Diagnostics GmbH
Class II
HISCL KL-6 Assay Kit
SEKISUI MEDICAL CO., LTD.
Class II
Line Polarized Light Pain Therapy
東京医研株式会社
Class II
Mick Applicator System
Mick Radio-Nuclear Instruments，Inc.
Class II
Sof-Tray Sheets
Ultradent Products, Inc.
Class II
Midas Rex MR8 ClearView Tools
Medtronic Powered Surgical Solutions
Class II
Guide drills for dental implant system
PointNix Co.,Ltd.
Class II
ElisaRSR™ IA-2 Ab Version 2
RSR Limited
Class II
Ultra-clean bench for in vitro fertilization
ASTEC CO.,LTD.
Class II
Electronic Biliary Endoscopy
オリンパスメディカルシステムズ株式会社
Class II
ENT MR8 ClearView
Medtronic Powered Surgical Solutions
Class II
PHOTO THERMOLYSIS DEVICE
Active Optical Systems Ltd.
Class II
Low Frequency Combination Stimulator
TRYCAM TECHNOLOGY CO.,LTD.
Class II
Factor II Assay Kit (Coagulation Method)
Roche Diagnostics GmbH
Class II
Single-use Lens Injection System
ODC Industries
Class II
POLYAMID monofilament non absorbable sterile surgical suture
TH. KAZANTZIDIS S.A. – MEDIPAC
Class II
Medical Device/IVD
Manufacturer
Category
Dental Implant
Dentis Co.,Ltd.
Class III
Dual Mobility Vivacit-E Polyethylene Hip Bearing
Zimmer Inc.
Class III
Clearlab eyedia multi-purpose solution
Clearlab SG Pte. Ltd.
Class III
NovaSure Impedance Controlled Endometrial Ablation System
Hologic, Inc.
Class III
Endoskeleton TCS Interbody System
Medtronic Sofamor Danek USA, Inc.
Class III
Adaptix™ Interbody System with Titan nanoLOCK™ Surface Technology
Medtronic Sofamor Danek USA, Inc.
Class III
Persona Trabecular Metal Knee System
Zimmer Inc.
Class III
SP-CL Hip Stem Prosthesis
Waldemar Link GmbH & Co.KG
Class III
CP-Monitor
Spiegelberg(GmbH&Co)KG
Class III
Opalescence Endo Endodontic Whitening System
Ultradent Products, Inc.
Class III
ROSA Recon Platform
Zimmer CAS
Class III
Comprehensive Reverse Shoulder System
Zimmer Inc.
Class III
Medical System for Ultrasound Diagnosis
Compumedics Germany GmbH
Class III
NeuroSpeed PTA Balloon Catheter
Acandis GmbH
Class III
AcrySof™ IQ Vivity™ Toric Extended Vision IOL
Alcon Laboratories, Incorporated
Class III
Self-curing general purpose adhesive for dental gum adhesives
As per the “Regulations for the
Supervision and Administration
of Medical Devices” (Order 739)
effective since 2021 and the new
“Good Clinical Practice of
Medical Devices” effective since
2022, China Shanghai local NMPA
conducted the onsite audit on 12
ongoing clinical trials with 19
clinical sites in Shanghai,
including 6 clinical trials for
Class II projects (3 active
devices and 3 IVDs) and 6
clinical trials for Class III
projects (4 innovative devices
and 2 dental implants).
The inspection results from
local NMPA disclose that the
basic quality of the clinical
trial process is controllable,
the content of the information
is traceable, and no serious
deviation, nor authenticity
issues, but there are some
compliance issues:
On July 19, NMPA issued a notice
on further strengthening and
improving the classification
management of medical devices.
The classification management of
medical devices is an important
foundational system for
regulatory oversight. In recent
years, China has continuously
promoted the reform of
classification management for
medical devices, improving the
management system and
operational mechanisms, and
timely revising the
classification rules and
catalog. As a result, the
regulatory effectiveness and
industry development have been
significantly enhanced.
On July 20, NMPA released the
updated “Medical Device Clinical
Evaluation Exempt Catalogue”
(NMPA, No. 71, 2021) in order to
manage the registration of
medical devices more
effectively.
Major items in this Clinical
Evaluation Exempt Catalogue:
