In March 2023, NMPA approved 290 medical devices, including 33 Class III imported products, 26 Class II imported products, and 227 Class III domestic products.
Below is a list of approved Class III and Class II imported products in March 2023.
Medical Device/IVD
Manufacturer
Category
Dental Putty-Bioactive Synthetic Bone Graft
NovaBone Products, LLC
Class III
ONALISA Lidocaine Filler
GENOSS Co., Ltd.
Class III
Accessories for Dental Implants
Biomet 3i, LLC
Class III
Continuous hemodialysis filter and supporting pipeline
Gambro Industries
Class III
Digital X-ray Radiography and Fluoroscopy system
Siemens Healthcare GmbH
Class III
Surgical Navigation System
Blue Belt Technologies, Inc.
Class III
Xpert® MTB/RIF Ultra
Cepheid AB
Class III
Lomatuell H Paraffin Gauze Dressing
Lohmann & Rauscher International GmbH & Co. KG
Class III
Single-use body cavity thermal perfusion line assembly
RanD S.p.A.
Class III
Pipeline™ Flex Embolization Device with Shield Technology™
Micro Therapeutics, Inc.DBA ev3 Neurovascular
Class III
Umbilical Vessels Catheter
Haolang Medical USA Corporation
Class III
HPV Positive Control Kit
Roche Molecular Systems, Inc.
Class III
Dental implant abutment
SAMWON D.M.P
Class III
Blood Collection Needles
Sarstedt AG & Co. KG
Class III
QUARTZ SPLINT
R.T.D.
Class III
Preloaded Intraocular Lens
HOYA Medical Singapore Pte. Ltd.
Class III
ENROUTE Transcarotid Neuroprotection System
Silk Road Medical, Inc.
Class III
Avelle Negative Pressure Wound Therapy(NPWT) System
ConvaTec Limited
Class III
ANATOMIC PEEK PTC Cervical Fusion System
Medtronic Sofamor Danek USA, Inc.
Class III
Image Guided Surgery Platform
Brainlab AG
Class III
ELECTRO DETACH GENERATOR v4
株式会社カネカ
Class III
3Dimensions Mammography System
Hologic, Inc.
Class III
Lumipulse® G HBsAg-Quant Calibrators
Fujirebio Inc.
Class III
Lumipulse® HBsAg Controls
Fujirebio Inc.
Class III
Staining Solution for Cataract Surgery
D.O.R.C. Dutch Ophthalmic Research Center (International) B.V.
Class III
Attune Cementless Knee System
DePuy (Ireland)
Class III
Augmented Mini Baseplate
Biomet Orhopedics
Class III
Surgery navigation system
X-Nav Technologies, LLC
Class III
HydroTac transparent/HydroTac transparent comfort
Paul Hartmann AG
Class III
Prismaflex HF20 Set
Gambro Industries
Class III
Active Thoracoscopic and Laparoscopic Hand Instruments
Olympus Winter & Ibe GmbH
Class III
NIM Vital Nerve Monitoring System
Medtronic Xomed, Inc.
Class III
Systane iLux MGD Thermal Pulsation System
Alcon Laboratories, Inc.
Class III
Clip device
ゼオンメディカル株式会社
Class II
Lava™ Esthetic
3M Deutschland GmbH
Class II
Single-use buried needle
(주)서치메디컬
Class II
Passive Thoracoscopic and Laparoscopic Hand Instruments
CIMDR Insights on China Medical Device Regulatory Environment
From March 1 to March 4, 2023, the 13th China International Medical Device Regulatory Forum (CIMDR) was held in Fuzhou, Fujian Province, China. CIMDR is one of the most important regulatory conferences in China on medical device, and NMPA, CMDE and related experts will attend this forum to release the latest regulatory updates. The major insights from the 13th CIMDR are listed as below.
NMPA CMDE will reconstruct the review process based on clinical orientation. The review of clinical evaluation reports (CER) based on equivalence for some products with matured review experience will be conducted by CMDE Department 1-6 rather than Clinical and Biostatistics Department 1-2.
The acceptance of registration projects (excluding class I) indicated a 12.1% year-over-year decrease, while the completion of such projects with 8.9% year-over-year increase from 2021. NMPA CMDE made max effort to increase the review efficiency.
NMPA continues to encourage the innovation of medica device. In 2022, the NMPA received 343 applications for special approval pathway of innovative medical devices, of which 68 were approved to enter the special review procedure; 55 innovative medical device registrations were approved.
Comprehensive clinical evaluation system has been established. In China, three clinical pathways of clinical evaluation exemption clinical evaluation based on equivalence and clinical trial are the most powerful basis to support and assist manufacturers to do a good job in clinical evaluation.
NMPA conducts nine upfront review pilot projects and six Hainan RWS fast track projects approved, among which two approved medical devices with RWE to support clinical evaluation were completed by BradyKnows.
NMPA Released the 45th Batch of Medical Device Approvals for 2023
On March 14, 2023, the NMPA issued the 45th batch of information on medical device approvals, including 9 new registration approvals with 5 new imported medical devices and 4 new domestic medical devices. Details are listed as below.
No.
Product Name
Applicant
Approval Data
1
Emergency and Transport Ventilator
Shenzhen Comen Medical Instrument Co., Ltd.
2023-03-13
2
Cerebrovascular Interventional Surgery Assist Operating System
Yidu Hebei Robot Tech Co., Ltd.
2023-03-13
3
High frequency surgical equipment
Xinjing Yunying Medical Technology (Zaozhuang) Co., Ltd. (BradyKnows Zaozhuang Company)
Xinjing Yunying Medical Technology (Zaozhuang) Co., Ltd. is a subsidiary of BradyKnows (BradyKnows Zaozhuang Company), focusing on high-frequency surgical equipment, accessories and other electrosurgical devices. In addition, BradyKnows Zaozhuang Company is a localization base for overseas medical device manufacturers to help our clients enter China faster and aim to support global distribution.
NMPA Latest Announcement on Implementation of China GB 9706.1-2020 and Related Standards on March 16, 2023
NMPA released the latest announcement on the implementation key issues of the new China GB 9706.1-2020 and collateral standards on March 16, 2023. GB 9706.1-2020 Medical electrical equipment—Part 1: General requirements for basic safety and essential performance has been released (IEC 60601-1:2012, MOD) on April 9, 2020, and will take effective since May 1, 2023. Its collateral standards have been released, and specialized standards are being published successively. Implementation key issues for GB 9706 series standards taking effective:
For the products with applicable specialized standards of GB 9706.1-2020, GB 9706.1-2020 and collateral standards can be implemented simultaneously with the final specialized standards. For the products with no specialized standards, GB 9706.1-2020 and collateral standards will be implemented since May 1, 2023.
For the products that have obtained the registration certificate or filing, considering that the test of the new standard has been greatly affected by COVID since 2020, a 3-year extension period and a 2-year extension period have been given for the change registration or change filing of the product. For example, for the product with applicable specialized standard, if the effective date of specialized standard is May 1, 2024, the change registration of the registered product shall be completed before May 1, 2027, and the change filing of the filed product shall be completed before May 1, 2026; If there is no applicable specialized standards for the product, or the effective date of applicable specialized standard for the product is May 1, 2023, the corresponding change registration shall be completed before May 1, 2026, and the corresponding change filing shall be completed before May 1, 2025.
As for the products for new registration or new filing after the implementation of the new standards, the manufacturers shall submit the test report meeting the requirements of the new standards, and then can be approved for marketing only after obtaining the registration certificate or filing.
China Released Measures for the Ethical Review of Life Sciences and Medical Research Involving Human
China authorities, including the National Health Commission (NHC), Ministry of Education, Ministry of Science and Technology and National Administration of Traditional Chinese Medicine, released the Measures for the Ethics Review of Life Sciences and Medical Research Involving Human on Feb 18, 2023.
The life science and medical research involving human refers to the research activities involving human subject or human biological samples and information data (including health records, behaviors, etc.). The Measures mentions the focus of Ethnic Committee, ICF, supervision etc. requirements, and the filing should be done for such research.
