China NMPA Newsletter – September 2022

Featured Articles

NMPA New Approvals In September 2022

In September 2022, NMPA approved 222 medical devices, including 24 Class III imported products, 33 Class II imported products, and 163 Class III domestic products.

Below is a list of approved Class III and Class II imported products in September, 2022.

Sources: NMPA

NMPA Notice on the Filing Examination Requirements for Medical Device Registration

On August 31, NMPA released a notice on the issue of Filing Examination Requirements for Medical Device Registration and other Documents (NMPA Notice No. 40 of 2022). According to the notice, the trial requirements issued with NMPA Notice No.42 of 2019 have been revised and the new requirements will be implemented from the date of release.

This revision involves a wide range of NMPA filing examination work, with 11 new requirements totaling 170 pages issued together with the notice.

For example, according to the newly released Filing Examination Requirement for Medical Device Registration, clinical evaluation will be completed by staff of NMPA’s Clinical and Biostatistics Department, instead of personnel from its Review Department or Clinical and Biostatistics Department as specified in the 2019 trial requirements. Besides, the basic review question has also been changed from “Is it definite that the product can be regulated as medical device?” to “Is it definite that the product can be regulated as medical device or the device-dominant combo product?”

BradyKnows elite team has rich experience in helping overseas clients to overcome challenges during China registration. If you have any questions on China market, please contact info@bradyknowsmedical.com.

NMPA Notice on the Publication of Guidelines for Quality Management System Audit of Medical Device Registration

In order to do a good job of quality management system audit under medical device MAH (Market Authorization Holder) system and improve the QMS audit quality for medical device registration, NMPA issued Guidelines for Quality Management System Audit of Medical Device Registration (NMPA, No. 50, 2022) on October 10, 2022.

This guideline is applicable to the on-site audit of the quality management system for Class II and Class III medical device registration carried out by the medical device regulatory authorities.

This guideline has a total of 73 audit items, of which 32 are marked with “*” key items and 41 general items.

It covers the key contents of quality management system, registration audit requirements, self-test audit requirements, etc. At the same time the quality management system principles, institutions and personnel, plant, facilities and equipment, document management, design and development, procurement, production, quality control, commissioned production and product authenticity as the key contents of the audit are explained in details.

Compared with the 2020 version, this version has added GMP, GCP and self-test provisions, clarifies the requirements for commissioned production and clinical, and revises and removes some of the content for easier execution.

BradyKnows elite team has rich experience in medical device quality management system audit, covering ISO 13485, FDA 21 CFR 820, ISO 11135, NMPA GMP etc. If you have any questions about the audit in China and NMPA overseas audit, please contact info@bradyknowsmedical.com.

China’s First Domestically Produced Proton Therapy System Gained Approval for Marketing

On Sep 26, 2022, NMPA approved the registration application of the innovative device “Proton Therapy System” produced by Shanghai APACTRON Particle Equipment Co., Ltd.

Consisting of the accelerator system and the therapy system, this device provides proton beams for radiotherapy. It is designed for the treatment of malignant solid tumors and certain benign diseases. Specific indications should be determined by clinicians according to the actual situation.

China has provided fast-track approvals for innovative medical devices. About 178 domestic and foreign innovative medical devices have been approved so far. The approval of the “Proton Therapy System” marks a new step in the localization of high-end medical devices in China and improves tumor diagnosis and treatment.

BradyKnows elite team provides turnkey solutions to innovative manufacturers from R&D, China entry strategy, registration, clinical evaluation and post-market surveillance.

If you have any questions on innovative pathway, please contact info@bradyknowsmedical.com. We would love to do more help on

your China business.

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

Keep Up With The Trend Of Medical Devices Localization In China: Background, Policy, Regulation, And Case Study

Date:

• Wednesday, November 2, 2022, 7:00am-8:00am(PDT), 10:00am-11:00am(EDT) (US and Canada)

• Wednesday, November 2, 2022, 4:00pm-5:00pm CET (Europe)

• Wednesday, November 2, 2022, 10:00pm-11:00pm(Beijing Time)

Since the release of “Made in China 2025” by the State Council of China in 2015, the localization of domestic medical devices is becoming a general trend. In recent years, the state has continuously introduced policies to encourage and support domestic substitution of medical devices.

In April 2022, the Anhui province issued the Circular on Regulation Government Procurement of Imported Products by Public Medical Institutions, which prohibits all public medical institutions from purchasing imported products without approval. Since 2021, Zhejiang, Guangdong, Sichuan, and Shanxi Provinces have successively released the latest “Imported Medical Device Procurement List” to tighten the product type and quantity of imported medical devices.  From encouraging to prioritizing domestic production, and now purchasing domestic medical devices, these policies have provided a more favorable competitive environment for domestic products.

For a long time, imported medical devices have occupied a leading position in the Chinese market, especially for high-end products. However, in most low-end markets, price and patient affordability remain decisive. International companies still face price-based simple competition, especially under the preference and protection of domestic production. To better develop the economical market, some companies decided to switch to local production.

As a leading consulting company for China’s medical device market entry, BradyKnows Medical has helped many international companies to develop China’s localization strategies to ensure their regulatory compliance with the local authorities. In this webinar, the agenda includes:

Agenda:

• Introduction of China localization of medical devices

• Key policies supporting medical device localization in China

• Multiple solutions to achieve China localization

• NMPA registration of domestic medical devices

Please click here to review the record of BradyKnows webinar.

• Introduction Of Medical Device Registration Process In China

• Medical Device Real World Evidence (RWE) In China: Policies, Usage, Study Plan, Case Study

• China Regulatory Updates Of Q1/2022 & Tips For Medical Device Registration Under Covid

• How To Increase The Likelihood Of China CER Approval?

• Keep Up With The Enhancement Of Medical Device Post-Market Surveillance In China: GMP, GSP, And NMPA Onsite Inspections

Resources – Documents Download

• GB/T 25102.1—2010 Electroacoustics—Hearing Aids—Part 1: Hearing Aids With Induction Pick-up Coil Input（April 1, 2011)

• GB/T 25102.100 Electroacoustics—Hearing Aids—Part 0: Measurement Of Electroacoustical Characteristics（April 1, 2011)

• YY 0989.7-2017 Implants For Surgery-Active Implantable Medical Devices-Part 7: Particular Requirements For Cochlear Implant Systems( Jan 1, 2018)

• GB 6174.1-2015 Implants For Surgery-Active Implantable Medical Devices-Part 1: General Requirements For Safety, Marking And For Information To Be Provided By The Manufacturer(July 1, 2017)

Resources – FAQ

• High Frequency Surgical Equipment Has Generator And Surgical Accessories, Are They Able To Submit Registration Separately? If Separately Registered, Do They Have To Clarify The Matching Situation?

• Ultrasound Soft Tissue Surgical Equipment Includes Main Engine, Transducer, Surgical Instruments, And Foot Switch. Will It Be Possible To Add Convertor Through Changes To Registration So That The Transducer And Surgical Instruments Can Be Connected Into Other Manufactures’ Main Engine?

• If Large-scale Imaging Equipment Provides A Third-party Physiological Gating Signal Interface, But Does Not Include Gating Equipment, What Aspects Should Be Considered In The Application Materials?

• Carbon Dioxide Laser Therapy Equipment Adopts New Design Structure Used For New Clinical Body Parts, Does It Need Animal Experiment? Do We Need The Control Group In The Animal Experiment?

• What Clinical Body Parts Should Be Included In Clinical Trials Of Medical X-ray Diagnostic Equipment ( Class M)?

• For Active Medical Devices With Software, How To Consider The Influence Of Software Difference Using Comparison With Predicate Medical Device In Clinical Evaluation?

• For Active Medical Device, Using Comparison With Predicate Medical Device In Clinical Evaluation, Can We Only Compare The Key Performances?

• Under What Circumstances Do Environmental Tests Need To Be Carried Out On Medical Electrical Equipment?

• When Submit Change Of Permission Items For Adding Models, Is It Necessary For Type Testing?

• When The Registration Certificate Of Active Products Is Changed, If There Is No Change To The Electrical Components^ But The Shell Structure And Overall Sealing Performance Of The Equipment Are Changed, Can The Electrical Safety And Electromagnetic Compatibility Test Be Exempted?

• Medical Endoscopes Have Several Models, How To Choose The Typical Model For Type Test?

• Do Medical Optical Endoscope And Laser Fiber Optics Need To Be Tested For EMC?

• Do Wireless Accessories Of The Active Medical Devices Need To Be Tested During The EMC Test?

• How To Choose The Operation Mode In EMC Test?

• How To Determine The Essential Performance Of Immunity Test In EMC Test Of Active Medical Devices?

• Is It Necessary For EMC Test Together With Inactive Accessories In Product Composition?

• How To Select EMC Test Samples?

• Is It Necessary To Associate EMC Test Report With Electrical Safety Test Report?

• In The Product Technical Requirements Of Active Medical Devices, How To Compose The “product Mode And Specification And Instruction For Division”?

• If The Active Medical Device Is Used With A Computer, How To Describe The Computer In The Product Registration?

• If Medical Device Does Not Have Internet Connections, Is It Not Applicable To The Cybersecurity Requirement?

• What Kind Of Medical Devices Are Applicable To The “Guidance For Premarket Review For Medical Devices Cybersecurity”? Can The Cybersecurity Description Document Be Submitted Within The Software Description Document?

• The Active Medical Device Contains The APP Software Used By Users. If The Android APP Is Registered, Is It Necessary To Be Tested When Adding IOS APP? Is Clinical Evaluation Data Required?

• If Active Medical Device Needs To Be Cooperated With Software, With Specified Software Version Listed In The Registration Certificate, When The Software Version Is Updated, Could The Software Information In The Device Certificate Be Updated During Registration Renewal?

• If Medical Device Software Is Updated, When Will It Need To Submit Change Of Permission Items?