China NMPA Newsletter – April 2022
Featured Articles
NMPA New Approvals In April 2022
In April 2022, NMPA approved 212 medical devices, including 35 Class III imported products, 20 Class II imported products, and 154 Class III domestic products.
Below is a list of approved Class III and Class II imported products in April, 2022.
| Medical Device/IVD | Manufacturer | Category |
| Hydrophilic-coated intravascular angiography catheter | Terumo | Class III |
| Ticron Coated Braided Polyester Nonabsorbable Suture | Covidien llc | Class III |
| Safari²™ Guidewires | Lake Region Medical | Class III |
| Healix Advance SP PEEK Anchor | Medos International SARL | Class III |
| LUCENCE | TEKNIMED S.A.S | Class III |
| Vantage Galan 3T MRT-3020 | Canon | Class III |
| Peripheral Coil System | MicroVention,Inc. | Class III |
| Laparoscopic high-frequency surgical instruments | GIMMI GmbH | Class III |
| Implantable Cardioverter/Defibrillators | MicroPort CRM S.r.l. | Class III |
| Stellant Flex Disposable Kit | Bayer Medical Care Inc. | Class III |
| SCENARIA View | Fuji Film | Class III |
| Dermalax Deep | ACROSS CO., LTD. | Class III |
| Collagen-based dental bone filling material | GENOSS Co., Ltd. | Class III |
| Triathlon Tritanium Knee System | Howmedica Osteonics Corp. | Class III |
| True Form Reshapable Guide Wire | Merit Medical Systems, Inc. | Class III |
| Tubing systems for Continuous Blood purification | Fresenius Medical Care AG & Co. KGaA | Class III |
| GO2 Steerable Guide Wire System | Merit Medical Systems,Inc. | Class III |
| Disposable blunt tip needle | (주)제일테크 | Class III |
| HydroSoft 3D Embolic System | MicroVention, Inc. | Class III |
| INDIGO Aspiration System | Penumbra, Inc. | Class III |
| Fresenius HD-Tubing systems | Fresenius Medical Care AG & Co. KGaA | Class III |
| Tubing Systems for Continuous Blood Purification | Fresenius Medical Care AG & Co. KGaA | Class III |
| Orthophos S 3D | Sirona Dental Systems GmbH | Class III |
| Resectoscope accessories | STEMA Medizintechnik GmbH | Class III |
| Hemodynamic and Electrophysiological Recording System | Siemens Healthcare GmbH | Class III |
| 20223130205 | NeoTract, Inc. | Class III |
| Dental Implant | Nobel Biocare AB | Class III |
| CD HORIZON Spinal System | Medtronic Sofamor Danek USA, Inc. | Class III |
| ACUVUE® VITA™ Brand Contact Lenses for ASTIGMATISM | Johnson & Johnson Vision Care,Inc. | Class III |
| Fracture and Correction System | In2Bones USA | Class III |
| ABT12 multi-purpose solution | Bausch & Lomb Incorporated | Class III |
| Resection endoscopes and accessories | GIMMI GmbH | Class III |
| Ultrasound Diagnostic Equipment | SAMSUNG MEDISON CO., LTD. | Class III |
| Aptima HIV-1 Quant Dx Assay | Hologic, Inc. | Class III |
| Lumipulse® G Pepsinogen II | Fujirebio Inc. | Class III |
| Erythropoietin (EPO) Quality Control | Siemens Healthcare Diagnostics Inc. | Class II |
| Lumipulse® ProGRP Controls | Fujirebio Inc. | Class II |
| 3D OCT-1 Maestro2 | Topcon | Class II |
| Ambu aView Monitor | Ambu A/S | Class II |
| Total Bile Acids | SENTINEL CH. S.p.A. | Class II |
| Therapy Monitor | Fresenius Medical Care AG & Co. KGaA | Class II |
| Rifampicin Susceptibility Test Disc | Oxoid Limited | Class II |
| Amoxycillin/Clavulanic Acid Susceptibility Test Disc | Oxoid Limited | Class II |
| Surgical Microscope | Leica Microsystems (Schweiz) AG | Class II |
| Vitamin D total II CalSet | Roche Diagnostics GmbH | Class II |
| CONTOUR CARE blood glucose meter | Ascensia Diabetes Care Holdings AG | Class II |
| EUROArrayScanner | EUROIMMUN Medizinische Labordiagnostika AG | Class II |
| Acrobat® 2 Calibrated Tip Wire Guide | Wilson-Cook Medical, Inc. | Class II |
| Primescan AC | Sirona Dental Systems GmbH | Class II |
| Androstenedione (ANDRO) | Siemens Healthcare Diagnostics Inc. | Class II |
| P-FDP CALIBRATOR | 希森美康株式会社 SYSMEX CORPORATION | Class II |
| D-Dimer CALIBRATOR NEO | SYSMEX CORPORATION | Class II |
| LIASAUTO CONTROL | SYSMEX CORPORATION | Class II |
| The F1 Battery Powered Micro system | Stryker Instruments | Class II |
| SpyScope DS II Access and Delivery Catheter | Boston Scientific Corporation | Class II |
Source: NMPA
NMPA Enhances Cross-reginal MAH Surveillance
The implementation of medical device MAH in China is aiming at promoting the reform of medical device review and approval mechanism and enhancing the management of medical device whole life cycle.
On April 2, 2022, NMPA issued a notice to provide recommendations on how to execute cross-regional MAH surveillance. These requirements are covered the current Measures for the Supervision and Administration of Medical Device Production in China are Bureau Order No. 53 issued in 2022.
More and more overseas manufacturers pay attentions on MAH, since they are aware of localization urgency.
Affected by factors such as supply chain, the cost of imported medical devices is higher than that of domestic medical devices. In the past, many foreign manufacturers do not have the urgency of localization. However, since the implementation of the volume-based centralized procurement, product prices plummeted, and the market competition has become more intense. Foreign manufacturers have started to consider how to reduce costs.
Regulatory Restrictions on the contract manufacturing in China
The current Measures for the Supervision and Administration of Medical Device Production in China are Bureau Order No. 53 issued in 2022.
For regulatory jurisdiction is described as
Those engaged in the production of medical devices or the supervision and administration of medical devices within the territory of the People’s Republic of China shall abide by the Measures. The most significant difference between this provision and the 2014 version is that the requirement for the filing of OEM entity only for export has been removed.
The medical products administrations of provinces, autonomous regions and municipalities is responsible for the supervision and administration of the production of medical devices within the administrative area of the province, autonomous regions and municipalities.
The National Medical Products Administration (NMPA) is responsible for the supervision, inspection, and management of overseas medical device registrants.
For contract production management is described as
Article 32: If the medical device registrant or filing entity entrusts any other party for production, the quality assurance ability and risk management ability of the entrusted party shall be assessed, a quality agreement for entrusted production shall be signed in accordance with the guidelines for entrusted production quality agreement formulated by NMPA, and the fulfillment of relevant agreed obligations by the entrusted party shall be monitored.
Although the scope of medical device registrants and filing entities is not limited here, when combined with the following terms:
Article 61: If the imported medical device registrant and filing entity appoints a domestic business entity as the agent, the agent shall assist the registrant and filing entity in fulfilling the responsibilities and obligations as prescribed in the Regulations on the Supervision and Administration of Medical Devices and under the Measures.
Article 62: The production of the imported medical devices shall meet the relevant requirements for producing medical devices in China and accept the overseas inspections organized by the NMPA. The agent shall be responsible for coordinating and cooperating with the related work of the overseas inspection.
Imported medical device registrants, filing entities, and agents refuse, obstruct, delay, or evade the overseas inspection organized by NMPA, resulting in the inability to carry out the inspection work and the inability to confirm the effective operation of the quality management system. NMPA may handle the situation by the provisions of Article 72, paragraph 2, of the Regulations on the Supervision and Administration of Medical Devices.
To sum up, NMPA has not yet given regulatory consent to foreign companies entrusting Chinese companies to manufacture and enter the Chinese market as imported products.
China Regulatory Updates of Q1 2022 & Tips for Medical Device Registration Under Covid
As we entered year 3 of the Covid pandemic, China medical device market continues to be attractive and competitive for many manufacturers globally. A total of 3,228 Class II and 3, 689 Class III products were approved by NMPA in 2021, showing an increase of 5.9% and 11.4% respectively compared with 2020, and these numbers are expected to go up again in 2022.
From the regulatory perspective, the implementation of Order 739 has triggered many key regulations and guidelines updates/release down the stream. Some key updates have already forced medical device manufacturers targeting the Chinese market to reformulate their regulatory & clinical strategy.
BradyKnows offers this webinar to help medical device professionals keep up with the major regulatory updates for medical device registration/compliance in China for the first quarter of 2022. You will also learn some tips for running successful medical device registration projects in China under the pandemic.
Agenda:
- Major regulatory updates for China medical devices in the first quarter of 2022 including:
- The 2022 National sampling inspection for the quality of medical devices
- SaMD/SiMD software registration and newly revised guidelines for AI, and cybersecurity
- Newly revised China GCP
- China local production (e.g. contract manufacturing)
- List of newly released product-specific guidance documents
- Tips for medical device manufacturers for running projects in China under the Covid including:
- Type testing
- Clinical studies
- NMPA communications
- Is It Necessary To Do Information Back Up And Filing For The Clinical Data Provided Or Open For Use?
- For Approved International Cooperation Projects, Does The Partner Need To Conduct Information Back Up And Filing?
- Is It Necessary To Apply For International Cooperative Scientific Research If The Scientific Research Carried Out By Using China’s Human Genetic Resources Is Funded By Foreign Parties But Has No Substantive Participation?
