China NMPA Newsletter – December 2022
Featured Articles
NMPA New Approvals in December 2022
In December 2022, NMPA approved 339 medical devices, including 37 Class III imported products, 25 Class II imported products, and 273 Class III domestic products. A total of 2,500 medical device products were approved by NMPA in 2022.
NMPA is encouraging China end uses for more domestic products in latest years. Thus, more and more overseas manufacturers are planning localization in China.
Below is a list of approved Class III and Class II imported products in December, 2022.
| Medical Device/IVD | Manufacturer | Category |
| Emprint™ Ablation System with Thermosphere™ Technology | Covidien llc | Class III |
| Single Photon Emission Computed Tomography System | Spectrum Dynamics Medical Ltd. | Class III |
| Insulin Pump | SOOIL Development Co., Ltd | Class III |
| HIV Ag/Ab Combo (CHIV) Assay | Siemens Healthcare Diagnostics Inc. | Class III |
| Anesthesia System | MAQUET CRITICAL CARE AB | Class III |
| Phacomeulsification/Vitrectomy system and accessories | D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. | Class III |
| HemosIL Normal Control Assayed | Instrumentation Laboratory Company | Class III |
| Medical X-Ray angiography equipment | GE MEDICAL SYSTEMS SCS | Class III |
| nGEN™ Generator | Biosense Webster (Israel) Ltd. | Class III |
| Disposable Syringe Needle | Feel Tech Co., Ltd. | Class III |
| Prowler Select Plus Infusion Catheter | Medos International SARL | Class III |
| RapidVit™ Omni media for vitrification | Vitrolife Sweden AB | Class III |
| LifeStent 5F Vascular Stent System | Angiomed GmbH & Co. Medizintechnik KG | Class III |
| Ranger / Ranger SL Over-The-Wire Paclitaxel- Coated PTA Balloon Catheter | Hemoteq AG | Class III |
| Microcoil System | Medos International SARL | Class III |
| Auxiliary articulation tube | Atos Medical AB | Class III |
| Soft (Hydrophilic) Contact Lens | CooperVision Inc. | Class III |
| AngioSculpt PTA Scoring Balloon Catheter | Spectranetics Corporation | Class III |
| Delta Xtend Reverse Shoulder System | DePuy (Ireland) | Class III |
| Angiographic Catheter | ANGIODYNAMICS,INC. | Class III |
| Cordis Angiographic Needle | Cordis Cashel | Class III |
| Multipurpose I.V.Connection System | VYGON | Class III |
| One-Link | Baxter Healthcare SA | Class III |
| TECNIS Synergy OptiBlue Intraocular Lens | Johnson & Johnson Surgical Vision, Inc. | Class III |
| CLYDESDALE PTC Spinal System | Medtronic Sofamor Danek USA, Inc. | Class III |
| V.A.C.VERAFLO Dressing Kit | KCI USA, Inc. | Class III |
| Cochlear Implants | MED-EL Elektromedizinische Geräte GmbH | Class III |
| Implantable Pacemaker | Medtronic Inc. | Class III |
| Peripheral Coil System | MicroVention,Inc. | Class III |
| Infant radiation warming table | アトムメディカル株式会社 | Class III |
| Sterile pen needles for single use | Novo Nordisk A/S | Class III |
| Microcatheter System | テルモ·クリニカルサプライ株式会社 | Class III |
| Lumipulse® HBcrAg Controls | Fujirebio Inc. | Class III |
| Cranial surgical navigation and positioning system | Medtronic Navigation, Inc. | Class III |
| cobas® Buffer Negative Control Kit | Roche Diagnostics GmbH | Class III |
| TrapLiner catheter | Vascular Solutions LLC | Class III |
| Teeth Whitening Gel | Nanova Biomaterials, Inc. | Class III |
| Response Reader Advanced System | Response Biomedical Corporation | Class II |
| Valleylab Smoke Evacuation Rocker Switch Pencil | Covidien llc | Class II |
| OMNI II Programmer | Impulse Dynamics (USA), Inc. | Class II |
| Flexible Video-Cystoskop HD | KARL STORZ SE & Co.KG | Class II |
| Calibrator sTfR II | Roche Diagnostics GmbH | Class II |
| Seramun SpotSight® plate mono | Seramun Diagnostica GmbH | Class II |
| Amber Mill Blocks & Disks | HASS CORPORATION | Class II |
| Dissecting Tools | Medtronic Powered Surgical Solutions | Class II |
| The Electric Stealth-Midas MR8 System | Medtronic Powered Surgical Solutions | Class II |
| Implant Handpiece-Contra-angle | KaVo Dental GmbH | Class II |
| Audio Processor | MED-EL Elektromedizinische Geräte GmbH | Class II |
| Laser systems for patient alignment | LAP GmbH Laser Applikationen | Class II |
| LIAISON® XS | DiaSorin S.p.A. | Class II |
| X-ray flat panel detector | キヤノン電子管デバイス株式会社 | Class II |
| Mammography X-ray unit | Planmed Oy | Class II |
| EmbryoScope Flex | Vitrolife A/S | Class II |
| EmbryoScope Flex | Vitrolife A/S | Class II |
| Patient Programmer | Medtronic Inc. | Class II |
| Patient Table | Dornier MedTech GmbH | Class II |
| BIS Extend sensor | Covidien llc | Class II |
| Portable X-ray system | Osstem Implant Co., Ltd. | Class II |
| McGRATH MAC Video Laryngoscope | Aircraft Medical Limited | Class II |
| BIOPHEN LMWH Control Low | HYPHEN BioMed | Class II |
| eG1 Cutting Tips | The Anspach Effort, Inc. | Class II |
| aTgII Quality Control (aTgII QC) | Siemens Healthcare Diagnostics Products Limited | Class II |
NMPA Adjusting Registration Application Payment Terms
NMPA issued a notice on the deferment of payment of registration review fees for drugs and medical device products (No. 81 of 2022) on September 29, 2022.
The main contents are as follows:
- Registration applicants who submit applications for registration of drugs and medical devices products and are accepted during the October 1 to December 31, 2022, the registration fee is suspended for one quarter from the date it is due, without late payment fees.
- Payment of review fees can be made by individuals using the payment code online transfer, but it needs to be handled in the bank that has opened the “non-tax payment” item.
- Recently, because of the Covid-19, the average acceptance review time will be increased by 2 working days on top of the original 5 working days.
NMPA Encouraging Enterprises to Lead Standard Drafting
According to the work deployment of the NMPA, the Center for Medical Device Standardization Administration NMPA has drafted the “Enterprise Led Drafting of Recommended Industry Standards for Medical Devices (Trial)” under the framework of the “Medical Device Standardization and Revision Management” to regulate the drafting of recommended industry standards for medical devices by enterprises. With the approval of the NMPA, the draft for comment is now available for public comment as required.
This is the description of the new and old standard system given by the National Standards Commission when the group standard came out in 2018, that is, the recommended industry standard should be dominated by the government.
NMPA Collects Public Comments On Guidelines for Registration Review of Implantable Medical Device Battery
In order to standardize the requirements for technical review and guide the registration and application of enterprises, CMDE has organized the drafting of the Guidelines for Registration Review of Implantable Medical Device Battery (Draft for Comments), which will solicit comments from now on.
Scope Of Application
These guidelines apply to implantable medical device batteries, for other medical device batteries also have some reference significance, including but not limited to lithium-ion batteries, nickel-metal hydride batteries, nickel-cadmium batteries, lead batteries, dry cells and other chemical batteries, photovoltaic batteries and other physical batteries, flexible batteries and other new batteries.
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
- How To Choose A Typical Product When Conducting A Test Of Performance Study On Orthopedic Implants?
- For Different Types Of Porcelain Powder Or Porcelain Block, If The Chemical Composition Of One Type Of Product Can Cover Other Types Of Products, Is It Possible To Select Only The Type Of Product For The Biocompatibility Test?
- What Aspects Should Be Paid Attention To In Biocompatibility Evaluation Of Single Use Tubing Systems For Hemodialysis?
- How To Select The Types Of Extraction Medium For Biological Tests?
- What Is The Difference Between Pyrogens And Bacterial Endotoxins In Medical Devices?
- Should Microbial Ingress Evaluation Be Carried Out For Needleless Connector Products For Infusion? How To Choose The Test Microorganism When Conducting Microbial Ingress Test?
- How To Perform Biocompatibility Evaluation On The Implant Products Processed Using Additive Manufacturing?
- When A Non-active Medical Device Changes, Under What Circumstances Should Re-evaluation Of Its Safety Be Considered?
- Which Biological Tests Require The Use Of Two Extraction Media In Biological Evaluation Of Dental Materials? As The Subchronic Toxicity Test Requires A Large Sample Size, It Is Possible To Consider Using Only One Extraction Medium?
- Under Which Circumstances Should The Pulp And Dentin Usage Test Be Taken Into Consideration During The Biological Evaluation Of Dental Materials?
- Is It Necessary To Conduct Subchronic Toxicity Test For Dental Noble-metal Alloys?
- Is Mouse Embryo Assay Required For Consumable Products For In Vitro Assisted Reproduction (except The Fluid For In Vitro Assisted Reproduction)?
- Is It Possible To Use The Same Raw Materials As Those Of The Final Product For Biocompatibility Test?
- If An Orthopedic Implant Made Of Pure Titanium Or Titanium Alloy Material Is Treated With Colored Anodizing, And The Surface Of The Product Contains Residual Impurity Elements In Addition To The Matrix Element, How To Perform The Biological Evaluation?
- In The Biocompatibility Evaluation Study Of Dressing Products, What Should Be Paid Attention To In Extract Preparation And The Selection Of Evaluation Items?
- If The Abutment Product Has Undergone Colored Anodizing Treatment, How To Submit The Biological Evaluation Data?
- What Are The Common Problems To Be Noted In The Subchronic Toxicity Test Section Of Biological Evaluation Report?
- Should All Models And Specifications Of Dialysate Concentrates Be Subjected To Stability Verification?
- How Should The Shelf Life Of A Dialysate Concentrate Product Be Determined? How Should The Stability Verification Studies Be Performed For Dialysate Concentrate Products?
- What Data Should Be Provided At Least For Radiation Sterilization Verification Of Non-active Implant?
- For Animal-derived Dental Biomaterials, If The Sterilization Method Is Changed, Can The Method Be Added Or Changed Through The Procedures For Change Of Permission Items?
- Does The Ophthalmic Viscoelastic Device Have To Be Terminally Sterilized, Or Can Aseptic Processing Instead Of Terminal Sterilization Be Acceptable?
- For Non-active Medical Device Products With Sterilized Packaging, How To Submit The Performance Evaluation Data For Primary Packaging?
- How To Set The Shelf Life Of Dental Burs And Drills?
- After Completing The Accelerated Stability Test And Study, Can The Product Be Stored And Transported Without Being Subject To Certain Conditions?
