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/IVDManufacturerCategory
Hydrophilic-coated intravascular angiography catheterTerumoClass III
Ticron Coated Braided Polyester Nonabsorbable SutureCovidien llcClass III
Safari²™ GuidewiresLake Region MedicalClass III
Healix Advance SP PEEK AnchorMedos International SARLClass III
Vantage Galan 3T MRT-3020CanonClass III
Peripheral Coil SystemMicroVention,Inc.Class III
Laparoscopic high-frequency surgical instrumentsGIMMI GmbHClass III
Implantable Cardioverter/DefibrillatorsMicroPort CRM S.r.l.Class III
Stellant Flex Disposable KitBayer Medical Care Inc.Class III
SCENARIA ViewFuji FilmClass III
Dermalax DeepACROSS CO., LTD.Class III
Collagen-based dental bone filling materialGENOSS Co., Ltd.Class III
Triathlon Tritanium Knee SystemHowmedica Osteonics Corp.Class III
True Form Reshapable Guide WireMerit Medical Systems, Inc.Class III
Tubing systems for Continuous Blood purificationFresenius Medical Care AG & Co. KGaAClass III
GO2 Steerable Guide Wire SystemMerit Medical Systems,Inc.Class III
Disposable blunt tip needle(주)제일테크Class III
HydroSoft 3D Embolic SystemMicroVention, Inc.Class III
INDIGO Aspiration SystemPenumbra, Inc.Class III
Fresenius HD-Tubing systemsFresenius Medical Care AG & Co. KGaAClass III
Tubing Systems for Continuous Blood PurificationFresenius Medical Care AG & Co. KGaAClass III
Orthophos S 3DSirona Dental Systems GmbHClass III
Resectoscope accessoriesSTEMA Medizintechnik GmbHClass III
Hemodynamic and Electrophysiological Recording SystemSiemens Healthcare GmbHClass III
20223130205NeoTract, Inc.Class III
Dental ImplantNobel Biocare ABClass III
CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc.Class III
ACUVUE® VITA™ Brand Contact Lenses for ASTIGMATISMJohnson & Johnson Vision Care,Inc.Class III
Fracture and Correction SystemIn2Bones USAClass III
ABT12 multi-purpose solutionBausch & Lomb IncorporatedClass III
Resection endoscopes and accessoriesGIMMI GmbHClass III
Ultrasound Diagnostic EquipmentSAMSUNG MEDISON CO., LTD.Class III
Aptima HIV-1 Quant Dx AssayHologic, Inc.Class III
Lumipulse® G Pepsinogen IIFujirebio Inc.Class III
Erythropoietin (EPO) Quality ControlSiemens Healthcare Diagnostics Inc.Class II
Lumipulse® ProGRP ControlsFujirebio Inc.Class II
3D OCT-1 Maestro2TopconClass II
Ambu aView MonitorAmbu A/SClass II
Total Bile AcidsSENTINEL CH. S.p.A.Class II
Therapy MonitorFresenius Medical Care AG & Co. KGaAClass II
Rifampicin Susceptibility Test DiscOxoid LimitedClass II
Amoxycillin/Clavulanic Acid Susceptibility Test DiscOxoid LimitedClass II
Surgical MicroscopeLeica Microsystems (Schweiz) AGClass II
Vitamin D total II CalSetRoche Diagnostics GmbHClass II
CONTOUR CARE blood glucose meterAscensia Diabetes Care Holdings AGClass II
EUROArrayScannerEUROIMMUN Medizinische Labordiagnostika AGClass II
Acrobat® 2 Calibrated Tip Wire GuideWilson-Cook Medical, Inc.Class II
Primescan ACSirona Dental Systems GmbHClass II
Androstenedione (ANDRO)Siemens Healthcare Diagnostics Inc.Class II
The F1 Battery Powered Micro systemStryker InstrumentsClass II
SpyScope DS II Access and Delivery CatheterBoston Scientific CorporationClass 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.


Resources – Webinar

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.


Resources – NMPA FAQs-HGRAC