In August 2022, NMPA approved 210 medical devices, including 25 Class III imported products, 22 Class II imported products, and 161 Class III domestic products.
Below is a list of approved Class III and Class II imported products in August, 2022.
Medical Device/IVD
Manufacturer
Category
SURGICEL Powder and SURGICEL Endoscopic Applicator
Ethicon,LLC
Class III
Radiofrequency Cannulas
Avanos Medical, Inc.
Class III
HIV Ag/Ab Combo (CHIV) Quality Control
Siemens Healthcare Diagnostics Inc.
Class III
Electroporation Generator
ANGIODYNAMICS, INC.
Class III
Implantable Cardioverter / Defibrillators
BIOTRONIK SE & Co.KG
Class III
SOFT CONTACT LENS
Bausch & Lomb Incorporated
Class III
Freka FKJ Set
Fresenius Kabi AG
Class III
Guidewires
朝日インテック株式会社
Class III
Free prostate specific antigen test kit (chemiluminescence method)
Siemens Healthcare Diagnostics Products Limited
Class III
Implantable Pacemaker
Vitatron Holding B.V.
Class III
Non-Invasive Lipolysis system
Cynosure, LLC
Class III
FilmArray® Meningitis/Encephalitis (ME) Panel
BioFire Diagnostics, LLC
Class III
Single-use sterile needle
(주)동방메디컬 분당지점
Class III
Vertebral Body Replacement
Medtronic Sofamor Danek USA, Inc.
Class III
Orthodontic Fixation Screw
GNI co.,ltd
Class III
MicroCatheter
Stryker Neurovascular
Class III
Surgical Navigation System
Paritic Inc.
Class III
MRIdian Linac System
ViewRay Incorporated
Class III
Infusion Pump
B. Braun Melsungen AG
Class III
Peripheral Implantation of Central Venous Catheter Kit and Accessories
L&Z US, Inc.
Class III
Dental Implants
SIC invent AG
Class III
Percutaneous endoscopic gastrostomy device
Fresenius Kabi AG
Class III
MicroCatheter
ACCURATE MEDICAL THERAPEUTICS LTD
Class III
Solitaire FR Revascularization Device
Micro Therapeutics, Inc.DBA ev3 Neurovascular
Class III
Dental implant system
medentis medical GmbH
Class III
Beating Heart Stabilizing & Positioning Devices
Terumo Cardiovascular Systems Corporation
Class II
CONTOUR Curved Cutter Stapler and Reloads
Ethicon Endo-Surgery, LLC
Class II
Ophthalmic Knives
マニー株式会社
Class II
Oral Dispenser
B.Braun Melsungen AG
Class II
D-Dimer detection kit (immunoturbidimetry)
SYSMEX CORPORATION
Class II
Pepsinogen I (PGI) Test Kit (Chemiluminescence Method)
Fujirebio Inc.
Class II
Calcitonin Test Kit (Microparticle Chemiluminescence Immunoassay)
Siemens Healthcare Diagnostics Inc.
Class II
Platelet Incubator
Helmer Scientific.
Class II
Surgical Table
STERIS SAS
Class II
CONTOUR Plus Blood Glucose Test Strips
Ascensia Diabetes Care Holdings AG
Class II
Medical endoscope LED Light Source
Aesculap AG
Class II
Accessories for Cochlear Implant Systems
Advanced Bionics AG
Class II
Disposable puncture and fascia suture sleeve group
In order to do a good job in the filing of Class I medical devices, the NMPA issued a notice concerning the filing of Class I medical devices (including Class I IVD) on August 11, 2022.
The Notice clarifies the product management category determination, filing information requirements, post-filing management and other content to further standardize the Class I medical devices (including the Class I IVD) filing-related work.
The Notice further clarifies the nature of filing, emphasizing that the filing entity submits the filing information that meets the requirements of the Class I Medical Device Filing Information Requirements And Instructions is completed after the filing. Also refine the filing information requirements, new product name, product description, intended use, model/ specification and other key content requirements.
As per BradyKnows experiences on Class I medical device filing, the timeline from kicking off project and dossier preparation to getting filing approval is estimated at one month. Our elite team has extensive experience in medical device filings and registration in China, please contact info@bradyknowsmedical.com for any questions.
In order to continuously optimize the business environment and promote the high-quality development of the medical device industry in Guangdong Province, on August 29, 2022, the Guangdong Provincial Drug Administration formulated the Guidelines on the Registration Application of Registered Class II Medical Devices (trial). It mainly describes the scope of application and the requirements of declaration.
Applicable scope of this guidance:
For cross-provincial mergers, reorganizations, or enterprises within the same group, the products that have obtained the Class II medical device registration certificate from outside the province moving to Guangdong for registration, and the products will not undergo substantial changes.
For overseas medical device registrants, through their sole proprietorships, joint ventures or authorized provincial registration applicants, transfer products that have obtained the Class II imported medical device registration certificate to Guangdong province for registration, there is no substantial changes in the products. The above scenario is also within the applicable scope of this guidance.
The Guangdong Provincial Drug Administration establishes communication channels and organizes the review department to communicate with enterprises in need. If it falls within the scope of application of guideline, the review department will organize the inspection of the medical device registration quality management system. If the verification is passed, the enterprise submits the registration application materials and the verification results of the registration quality management system.
BradyKnows has helped many domestic and overseas medical device manufacturers apply for NMPA registration with the least burdensome solution for China entry. Please contact info@bradyknowsmedical.com for any questions.
On August 10, 2022, NMPA issued a notice to collect public comments to establish industry standards of MD clinical evaluation and IVD clinical performance studies in terms and definitions.
NMPA released the Medical Device Clinical Evaluation-Terms and Definitions (2022 Draft for comments) and Clinical Performance Studies of In Vitro Diagnostic Reagent – Terms and Definitions (2022 Draft for comments). Both documents define terms and definitions for medical device and IVD clinical evaluation, including those commonly used in clinical investigation designs, conducts, records and reports. It lays the foundation for medical device clinical evaluation. The standard involves no specific products and serves as a recommended one, which will be implemented 12 months after publication.
It is a great opportunity to have your voices heard by NMPA reviewers and get involved in the process. If you have any comments on this, please contact info@bradyknowmedical.com before October 1, 2022. We will help you submit your comments to NMPA before October 8, 2022
