China NMPA Newsletter – January 2023

2023-03-08

Featured Articles

NMPA New Approvals in January 2023

In January 2023, NMPA approved 124 medical devices, including 11 Class III imported products, 12 Class II imported products, and 99 Class III domestic products.

Below is a list of approved Class III and Class II imported products in January 2023.

Medical Device/IVD	Manufacturer	Category
Cardiac Resynchronization Device Tiered-therapy Cardioverter/Defibrillator	St. Jude Medical Coordination Center BVBA	Class III
Bio-Medicus Life Support Catheter and Introducer	Medtronic, Inc.	Class III
BD Vacutainer® Safety-Lok™ Blood Collection Set	Becton Dickinson and Company	Class III
Belotero Volume Lidocaine	Anteis SA	Class III
Athletis OVER-THE-WIRE PTA Balloon Dilatation Catheter	Boston Scientific Corporation	Class III
Restylane Volyme	Q-Med AB	Class III
TiBases and Screws	Zfx GmbH	Class III
Medical X-Ray angiography equipment	GE MEDICAL SYSTEMS SCS	Class III
Diagnostic Ultrasound System	ESAOTE S.p.A.	Class III
Ultrasound Diagnostic Equipment	SUPERSONIC IMAGINE	Class III
Cardiac Resynchronization Device Tiered-therapy Cardioverter/Defibrillator	St.Jude Medical Coordination Center BVBA	Class III
Dissecting Tools	Medtronic Powered Surgical Solutions	Class II
Riptide™ Large Bore Aspiration Tubing	Micro Therapeutics, Inc.DBA ev3 Neurovascular	Class II
Vertebroplasty Adjuncts	Seawon Meditech Co., Ltd.	Class II
Subcyclo Probe	QUANTEL MEDICAL	Class II
HDL Cholesterol Calibrator (HDLC CAL)		Class II
QUANTA-Lyser 3000 ELISA/IFA + Incubator	INOVA Diagnostics, Inc.	Class II
Automatic air mattress systems	Care of Sweden AB	Class II
Mobile ECG Atrial Fibrillation Alert Software	삼성전자(주)	Class II
Wrist0x2 Pulse 0ximeter	Nonin Medical,Inc.	Class II
Diagnostic X-Ray tube	VAREX IMAGING CORPORATION	Class II
Skater Fix	Argon Medical Devices, Inc.	Class II
Aqua Maris® Strong nasal spray	Jadran-Galenski laboratorij d.d.	Class II

NMPA CMDE Annual Report for Year 2022

The Center For Medical Device Evaluation of NMPA (NMPA CMDE for short) has made a summary of the work in 2022, the report is as follows:

Ⅰ. Registration application

It accepted 20,865 applications for registration of medical devices, including 5,389 filing changes, 2,035 imported Class I filing. A total of 13,066 applications were transferred to the technical review process, the transfer of the finalized project 14,486, 1,300 more than in 2021, an increase of 9.9 percent year-on-year.

II. Emergency Review Status

11 Nucleic acid test kit
10 Antibody test kit
47 Antigen detection kits
2 Medical device products

III. Review time

Application Type	Product Category	Average review time	Average time for expert consultation	Average time for applicant supplementary phase	Total time
Product Registration	Class II	72	0	245	317
	Class III	99	1	178	278
	Class II+Class III	95	1	187	283
Registration change of permitted matters	Class II	45	0	81	126
	Class III	69	0	60	129
	Class II+Class III	64	0	64	128
Renewal Registration	Class II	24	0	13	37
	Class III	46	0	28	74
	Class II+Class III	39	0	24	62

IV. Collective decision-making

29 meetings of CMDE technical meetings
679 meetings of CMDE branch technical meetings

Ⅴ. Deficiency letter, expert panel meeting and audit

Supplementary Information for deficiency letter
Issued 5,698 deficiency letters
Received 5,626 items of supplementary dossiers
Expert panel meeting
Initiated 114 expert panel meetings
Organized 107 expert panel meetings
QMS audit
Initiated 2,465 QMS audits
Received 2,125 auditing results

Ⅵ. Innovation and priority review

Special review of innovative medical devices

Received 343 innovation applications, up 37.8% year-on-year;
Organized and held 309 expert review meetings;
Completed review of 361 items.

Priority approval for medical device audits

Received 31 priority approval requests, down 24.4% year-on-year;
Organized 13 expert review meetings;
Completed the review of 34 items.

Ⅶ. Manufacturer consulting

Provided 7,717 times ofpre-acceptance consultation
Provided 6,466 times of supplementary dossier consultation

The Ministry Of Finance of China Reduces Tariffs On Imported Medical Devices

To protect human health and reduce patients’ economic burden, the Ministry of Finance of the People’s Republic of China issued the tariff adjustment plan on December 29, and will reduce import tariffs for 13 types of medical devices from January 1, 2023; and 37 types of medical device products will achieve zero import tariffs.

Policy Highlights

Further reduction of import tariffs for some medical devices

China will implement provisional import tax rates lower than the most-favored-nation (MFN) tariff rate for 1020 items. Among them, 13 types of medical devices such as spring rings, dentures, raw materials for vascular stents and contrast agents will achieve further reduction in import tariffs starting Jan 1, 2023.

Zero import tariff for some medical devices

The eighth step of tariff reduction will be implemented for the MFN tariff rate of the products listed in the Amendment to the Tariff Concession Schedule of the World Trade Organization Accession Protocol of the People’s Republic of China for the expansion of the information technology agreement. After the implementation of the policy, 37 types of medical device products will achieve zero tariff on imports starting July 1, 2023.

New tax item for surgical robots

In the adjustment of import and export tariffs, it is clear that surgical robot tax items will be increased in 2023 to meet the needs of industrial development and scientific and technological progress. Surgical robot refers to a medical device consisting of a robotic arm, console, imaging system and other components that can perform complex surgical operations in a minimally invasive manner. Including orthopedic surgery robot, neurosurgery robot, radiation interventional surgery robots.

NMPA Facilitates the Usage of Medical Device Master Files

The NMPA issued a notice on further clarifying matters related to the registration and use of the master files of medical devices on January 18, 2023.

Combined with the registration and use of medical device master files, the following matters are clarified:

Medical device master file is a form of technical data, such data is submitted directly by its owner to the medical device regulator, used to authorize the applicant for registration of medical device products in the declaration of medical device registration and other matters. The registration of medical device master file is a voluntary act.
Medical device master file registration is mainly related to medical device raw materials. Medical device master file system applies to the medical device registration applicant in China’s imports of Class II, Class III and domestic Class III medical devices (including in vitro diagnostic reagents) registration, changes, clinical trial approval and other applications referenced in the registration of the master file. According to the actual situation, local NMPA can carry out the main file registration items of domestic Class II medical devices by referring to this announcement.

New China CER Website

The new website was built based on the newly updated clinical evaluation requirements and regulation in China under the Order 739.

We are here to help you obtain China market approval for your medical devices with a comprehensive Clinical Evaluation Report (CER). Before jumping to any conclusions, use our newly developed tool for a

CER FEASIBILITY SELF-EVALUATION

Resources – Webinar/Short Videos

Please click here to review the record of BradyKnows webinar and short videos.

Revisiting 2022 And Looking Into 2023: Regulatory Updates For Medical Device Market Access In China
Keep Up With The Trend Of Medical Devices Localization In China: Background, Policy, Regulation, And Case Study
What is Hainan Boao Lecheng International Medical Tourism Pilot Zone?
What Can International Medical Device Manufacturer Do in Hainan Medical Tourism Pilot Zone?
Hainan Urgent Use Program for International Medical Device Manufacturers
China’s Medical Device -Clinical Evaluation Pathways
Real-World Evidence for NMPA Premarket Clinical Evaluation
Faster China NMPA Approval via Real-World Study in Hainan
Commercial & Regulatory Benefits of Entering Hainan Pilot Zone
Usage of Real-World Evidence for Medical Devices China vs. US

Resources – FAQ