9 Key events in China healthcare in 2022

▍01# Fifty-five innovative medical devices were approved for sale

In 2022, a total of 55 innovative medical devices were approved for marketing, which is the largest number of innovative products approved for marketing since the implementation of the special approval procedure for innovative medical devices. By the end of 2022, more than 180 innovative medical devices have been approved for listing through special approval or review procedures.

Comments: The release and implementation of Special Examination and Approval Procedures for Innovative Medical Devices (Trial) (revised into Special Examination and Approval Procedures for Innovative Medical Devices in 2018) set up a “green channel” for rapid examination and approval of innovative medical devices.

▍02# Implementation of the newly revised Class I Medical Device Product Catalog

On January 1, 2022, the newly revised Category I Medical Device Product Catalog came into effect. The catalog comprehensively integrates the information of Category I medical device products in 2014 edition, 2017 Edition and related medical device classification and definition documents published in the past, with the 2017 edition catalog as the main framework. It contains 19 subdirectories, 119 first-level product categories, 368 second-level product categories and 2,629 product name examples in the 2017 edition of the catalog, which increases 90 pieces of product information and 538 new product name examples compared with the 2017 edition of the catalog.

▍03# Medical Device Production Supervision and Management Measures and Medical Device Operation Supervision and Management Measures were issued and implemented

On March 22, 2022, the State Administration for Market Regulation issued the revised Measures for the Supervision and Administration of Medical Device Production and the revised Measures for the Supervision and Administration of Medical Device Business, which will come into force on May 1, 2022. The two management measures strictly implement the “four strictest” requirements, implement the provisions of the “Regulations on the Supervision and Administration of medical devices”, fully implement the registration system of medical devices, optimize the administrative license handling process, strengthen the supervision and inspection measures, improve the supervision and inspection means, consolidate the main responsibility of enterprises, and further increase the punishment for illegal behaviors.

▍04#The newly revised Quality Management Standard for Clinical Trials of Medical Devices has been issued and implemented.

On March 31, 2022, the NMPA and the National Health Commission jointly issued the newly revised “Clinical Trial Quality Management Standards for Medical Devices”, which will come into force on May 1, 2022. The newly revised Quality Management Standards for Clinical Trials of Medical Devices combined with industry needs and regulatory practice, simplified and optimized relevant requirements, strengthened the responsibilities of relevant parties in clinical trials of medical devices, and included the quality management requirements for clinical trials of in vitro diagnostic reagents.

Comment: Now, the medical device clinical trial organization has been changed from qualification to record management.

▍05#The NMPA established a centralized unit for standardization technology of traditional Chinese medicine devices

On June 7, 2022, the NMPA issued an announcement and decided to establish a centralized unit for standardization technology of traditional Chinese medicine devices. The centralized unit of standardization technology of traditional Chinese medical devices is mainly responsible for the preparation and revision of basic general standards, product standards, method standards and other relevant standards in the field of traditional Chinese medical devices.

▍06#“Implementation Plan for Supporting Hong Kong and Macao Medical Device Registrants to Produce Medical Devices in 9 Mainland Cities of Dawan District” was released

 On June 29, 2022, the NMPA issued the Implementation Plan for Supporting Hong Kong and Macao Medical Device Registrants to Produce Medical Devices in 9 Cities in the Mainland of Dawan District (hereinafter referred to as the Implementation Plan), detailing the scope of application, working procedures, application path and material requirements of cross-border commissioned production of Hong Kong and Macao enterprises, and clarifying the division of responsibilities between the State Food and Drug Administration and Guangdong Food and Drug Administration.

▍07#The NMPA strengthens the supervision of decorative color contact lenses

On August 30, 2022, the NMPA issued the Notice on the Special Rectification Action to Regulate the production and marketing behavior of Decorative Colored Contact Lenses and decided to organize a three-month special rectification action to regulate the production and marketing behavior of decorative colored contact lenses nationwide from September 1, 2022. This special rectification action focused on severely cracking down on the production and operation of unregistered decorative color contact lenses, illegal online sales, lack of medical device production and operation qualifications, and over-range operations, and seriously investigating and punishing relevant cases, punishing offenders, exposing typical cases, eliminating potential quality and safety risks, establishing and improving mechanisms, and forming a standardized and orderly market order.

▍08#  The first domestic proton therapy system was approved for market

On September 26, 2022, the NMPA approved Shanghai APACTRON Particle Equipment Co., Ltd, an application for registration of the proton therapy system innovation products.

The product provides proton beams for radiotherapy, which can reduce the dose of surrounding normal tissue, especially the tissue behind the target, while achieving a high dose at the tumor site. It is suitable for the treatment of systemic solid malignancies and certain benign diseases.

Comments: As the first domestic proton therapy system approved for market in China, the key technologies and core components of this product are all domestically produced. The overall function and performance of this product are comparable to that of imported devices, and its operation is stable and reliable.

▍09#  Medical sodium hyaluronate product management category is clear

On November 14, 2022, the State Food and Drug Administration issued the Announcement on the Management Categories of Medical sodium hyaluronate products, which clarified the management attributes and management categories of medical sodium hyaluronate (sodium hyaluronate) products with different intended uses (indications) and working principles, so as to strengthen the supervision and management of medical sodium hyaluronate (sodium hyaluronate) products. We will further standardize the registration and filing of related products to ensure the safety and effectiveness of medicinal devices for public use.

China is encouraging China end uses for more domestic products in latest years. Thus, more and more overseas manufacturers are planning localization in China. BradyKnows localization team has extensive experiences in facility establishment, audit, supplier evaluation, manufacturing, registration, and marketing in China. Pls feel free to let us know any questions on China entry via info@bradyknowsmedical.com

Source：Yixintong

Translated & edited by Bradyknows