China NMPA Newsletter – November 2022

Featured Articles

Seize Golden Chance To Facilitate Your Market Access To China: Shanghai Launched Several Favorable Measures For Overseas MedTech Companies

In order to support the development of biomedical R&D economy, Shanghai Municipal Drug Administration issued a number of policy measures to accelerate the development of global biomedical R&D economy and industrialization on November 21, 2022.

Main Objective

By 2025, the development pattern of global biomedical R&D economy and industrialization will be initially formed; The overall scale of the R&D economy reached over 100 billion yuan; Cultivate or introduce more than 100 blockbuster products of innovative medical devices; Cultivate more than 50 innovative headquarters with multiple functions of biomedical R&D, sales and settlement; More than 20 high-level biomedicine incubators and accelerators will be cultivated.

By 2030, Shanghai’s position in global biomedical R&D economy and industrialization will be further highlighted. A number of innovative drugs and medical devices that are developed and listed in Shanghai will emerge, and a number of innovative biomedical headquarters and innovation platforms with domestic and international influence will be gathered.

Policy Highlights

• Enhance capacity for R&D and innovation;

• Support new models of R&D and production of innovative drugs and medical devices;

• Introduce and cultivate innovative headquarters;

• Support the construction of high-level incubation and transformation platforms;

• Increase the activity of biomedical intellectual property trading;

• Support the launch and use of R&D innovative products;

For the products that meet the conditions and enter the national and municipal special examination procedures for innovative medical devices, the qualified products will be given no more than 30% of the R&D investment and no more than 5 million yuan of financial support according to the procedures.

Brady is particularly aware of the process of special review procedures that can help applicants to complete the registration of innovative medical devices in a scientific and rational manner. For more questions, please contact info@bradyknowsmedical.com.

China Starts Implementing The Third Batch Of Medical Device UDI

NMPA issued the Announcement on the implementation of the third batch of Medical Devices UDI (Draft for Comments) on November 30, 2022. (Hereinafter referred to as the Draft for Comments).

The draft for comments points out that, in accordance with the risk degree and regulatory needs, some disposable products with great clinical demand, varieties listed in the scope of medical insurance collection, medical cosmetology related products and other Class II medical devices will be identified as the unique identification and implementation of the third batch of medical devices.

The implementation of the third batch unique identification of medical devices catalog includes 141 medical devices, such as ultrasound surgical equipment accessories, medical laser fiber, high-frequency surgical equipment, electric anastomoses, vascular suture devices, optical endoscopes, electronic endoscopes, peritoneal dialysis equipment, pacing system analysis equipment, biopsy needles, protective clothing, hearing aids, blood cell analysis instruments, etc.

For the medical devices listed in the third batch of implementation product catalog, the registration applicant shall pay attention to the following points:

According to the draft, medical devices manufactured from June 1, 2024, should have a UDI; The third batch of products previously produced with unique marking may not have unique marking. The production date is subject to the label of the medical device.

For those applying for registration from June 1, 2024, the applicant shall submit the product identification of its smallest sales unit in the registration management system; If the registration has been accepted or approved before June 1, 2024, the registration applicant shall submit the product identification of its minimum sales unit in the registration management system when the product registration is renewed or changed.

For the medical devices manufactured from June 1, 2024, before they are put on the market, the registration applicant shall upload the product identification of the minimum sales unit and higher level packaging and relevant data to the unique identification database of medical devices in accordance with relevant standards or specifications, so as to ensure that the data are true, accurate, complete and traceable.

For medical devices whose information has been maintained in the medical Insurance Medical Consumables Classification and code database of the National Healthcare Security Administration, the medical insurance medical consumables classification and code fields should be supplemented and improved in the unique identification database of medical insurance medical consumables. Meanwhile, relevant information about the UDI of medical devices should be improved in the maintenance of the medical insurance medical consumables classification and code database, and the consistency with the data in the medical device UDI database should be confirmed.

The more detail information of the third batch of medical devices UDI startup in China, please contact info@bradyknowsmedical.com.

NMPA Medical Device Classification Catalogue Updating

According to the Working Procedure for Dynamic Adjustment of the Medical Device Classification Catalogue and related requirements, the  Center for Medical Device Standardization Administration, a branch of NMPA, organized the professional group of the Technical Committee of Medical Device Classification to study and form the dynamic adjustment opinions of the Medical Device Classification Catalogue on the basis of collecting the adjustment opinions of the Medical Device Classification Catalogue in the early stage. And now they are soliciting public opinions.

In this new Catalogue update version, some medical devices are upgraded to Class III from Class II, such as ultrasound cutting coagulating shears, or Class III down to Class II, or Class I upgraded to Class II.

NMPA Notice On Medical Sodium Hyaluronate Product Category

With the rapid development of science and technology and industry, new products continue to emerge. The NMPA issued the Notice On Medical Sodium Hyaluronate Product Category on November 14, 2022 (No.103, 2022, hereinafter referred to as Notice No. 103).

The main content of the revision consists of 11 articles:

• At present, sodium hyaluronate products are used at the edge of drugs, medical devices and cosmetics. Notice No. 103 has identified the classification of edge products and drug-device combination products involving sodium hyaluronate.

• A medical sodium hyaluronate product for the treatment of urinary bladder epithelial glucosamine protective layer defects has been approved for marketing as a Class III medical device. This kind of product is not approved in accordance with the situation of drug marketing.

• When the medical sodium hyaluronate product is used for injection into the dermis and below, as an injection filling product to increase tissue volume, if the product does not contain pharmaceutical ingredients to play pharmacological, metabolic or immunological effects, it shall be regulated as Class III medical device; If the product contains local anesthetics and other drugs, it is judged to be a drug-device combination product mainly based on medical devices.

• When the medical sodium hyaluronate products are injected into the dermis to improve the skin condition mainly through the moisturizing and hydrating effects of sodium hyaluronate, if the products do not contain pharmaceutical ingredients that play pharmacological, metabolic or immunological effects, they shall be regulated as Class III medical devices; If the product contains local anesthetics and other drugs, it is judged to be a drug-device combination product mainly based on medical devices.

• Medical dressings that clearly contain sodium hyaluronate in Notice No. 103 are regulated as medical devices if they do not contain pharmaceutical ingredients that have pharmacological, metabolic or immunological effects; If it can be partially or completely absorbed by the body or used for chronic wounds, it should be regulated as Class Ⅲ medical device. If it can not be absorbed by the body and is used for non-chronic wounds, it should be regulated as Class II medical device.

• In view of the fact that scar repair materials assisting in improving and preventing the formation of dermatologic rational scars have been listed in the Classification Catalogue of Medical Devices (14-12-02), scar repair materials shall be regulated according to Class II medical devices. When such products contain sodium hyaluronate, their regulation properties and categories do not change.

• Sodium hyaluronate is generally extracted from animal tissues or produced by microbial fermentation, which has certain potential risks. The safety and effectiveness of Class I medical devices cannot be guaranteed by regulatory measures. Therefore, the regulation category of medical sodium hyaluronate products under the regulation of medical devices should not be lower than Class II.

• Sodium hyaluronate has been used in cosmetics. Products containing sodium hyaluronate for the purpose of cleaning, protection, modification and beautification shall not be administered as drugs or medical devices. Such products should not be claimed for medical use.

• Lotion, disinfectant solution and antiseptic swab that are only used to disinfect damaged skin and wounds shall not be administered as drugs or medical devices.

• If the modified sodium hyaluronate is verified to be consistent with the relevant physical, chemical and biological properties of sodium hyaluronate, the regulation attributes and categories may be implemented by reference to this notice.

• In order to clarify the implementation requirements, the relevant matters of registration application under different circumstances are stipulated. For the situation involving the transformation of product regulation attributes or categories, the implementation transition period of about 2 years is given to ensure a smooth transition.

If you have any questions on Medical Sodium Hyaluronate Products, please contact info@bradyknowsmedical.com.

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

Resources – Webinar/Short Videos

Please click here to review the record of BradyKnows webinar.

• 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

• What Should Be Noticed In The Shelf Life Verification Of Non-active Implantable Devices With Sterilized Packaging?

• What Are The Raw Material Requirements For Non-electrically Driven Infusion Pumps For Single Use?

• What Data Should Be Provided For The Mechanical Performance Study Of Orthopedic Implants?

• What Should Be Considered In Performance Evaluation Of The Individual Component Of Artificial Joint Products During Registration Application As A Single Component?

• How Should Fatigue Limits For Orthopedic Implant Products Be Obtained?

• When Finite Element Analysis Tool Is Used To Evaluate The Performance Of A Product, What Aspects Should Be Paid Attention To?

• What Should Be Noted In The Process Verification Of The Final Cleaning Of Metal Orthopedic Implants?

• What Aspects Should Be Considered In The Study Of Static And Dynamic Mechanical Properties Of Orthopedic Implants?

• For Medical Devices Made Of Biological Tissue Materials Such As Animal-derived Or Allogenic Tissues Through The Decellularization Process, Which Item Requirements Related To Quality Control Of Immunogenicity Should Be Considered At Least?

• What Should Be Noted In The Fatigue Test And Study Of Intravascular Stent?

• In The Product Test Report, What Should Be Focused On When Applying For The Registration Of Dialysate Concentrate For Hemodialysis?

• How To Choose Similar Products When The Safety And Effectiveness Evaluation Of The Product Under Application Involves The Comparison With Similar Products?

• For Marketed Animal-derived Dental Biomaterials, If There Are Changes In The Geographical Origins Of Animals, But No Change In The Animal Type, Sampling Site And Tissue Type, And Both The Technical Requirements And Registration Certificate Do Not Reflect The Geographical Origins Of Animals, Is It Necessary To Apply For Change Of Permission Items?

• How To Determine The Cutting Performance (end Cutting, Side Cutting) Of Dental Drill For Implant?

• What Data Should Be Submitted For Absorbable Hemostatic Products To Prove The Hemostatic Mechanism Of The Product?

• What Are The Factors To Be Considered In The In Vitro Degradation Test Of Absorbable Hemostatic Products?

• What Is The Recirculation Of A Central Venous Catheter For Blood Purification? What Is Its Significance For Measurement?

• What Are The Requirements For The Hardness Of Key Components Of The Stapler?

• In The Performance Study Of Individualized Abutments, What Contents Should Be Focused On?

• When Abnormal Results Are Present In The Study On Chemical Performance Of Non-active Medical Device Products, How To Make Evaluation?

• What Technical Files Should Be Provided If The Soft Corneal Contact Lenses Use Aspheric Optics Intended To Improve Optical Imaging?

• As To The Related Requirements In YY/T 0308 “Medical Sodium Hyaluronate Gel” For Shear Viscosity, Intrinsic Viscosity Number, Weight Average Molecular Weight And Moleeular Weight Distribution Coefficient How Should Cross-linked Sodium Hyaluronate Gel For Injection Products Refer To Such Requirements?

• Is An In-vitro Degradation Test Required For Injectable Sodium Hyaluronate Gel For Plastic Surgery? What’s The Specific Requirement?

• For Implantable Drug-supplying Device With Coatings What Kind Of Performance Studies Should Be Carried Out?

• What Should Be Included In The Quality Control Of Processing Aids Used In The Production And Processing Of Orthopedic Implants?

• What Should Be Noted In The Development Of The Performance Requirements And Performance Indicators For The Suture In Suture Anchors?

• How To Define The Sphericity Of Metal Powder For Additive Manufacturing In Dentistry? Why Is It Necessary To Specify The Sphericity Of Powder?

• For The Orthodontic Anchor Screw Made Of The Same Materials As Those Of The Marketed Products Is It Necessary To Conduct The Fatigue Test And Study?

• For The Wear Performance Study Of Components Made From Polyethylene Materials In Artificial Joint Products, Is It Acceptable To Use The Wear Performance Research Data Of Ordinary Ultra-high Molecular Weight Polyethylene Products To Replace That Of Highly Cross-linked Ultra-high Molecular Weight Polyethylene Products?