May 6, 2020

In early March, we reported on emergency measures being employed in various Asia-Pacific countries, including China, to combat the COVID-19 pandemic. Since that time, some noteworthy new developments have occurred as part of China’s regulatory response.

Detailed requirements for IVD test kits and PPE

On March 30 the National Medical Products Administration (NMPA) summarized the regulatory requirements and standards for COVID-19 IVD detection reagents and personal protective equipment (PPE), as follows:

  • The NMPA classifies COVID-19 detection reagents as Class III IVDs. Therefore, companies must apply for registration and submit the required documents, which are listed in the announcement.
  • Medical masks and protective clothing are regulated as Class II medical devices, while goggles and face shields​ are regulated as Class I medical devices. Three mandatory Chinese ​standards and one voluntary standard are applicable to these devices, as follows: (1) GB 19082-2009 (Technical Requirements for Single-Use Protective Clothing for Medical Use), (2) GB 19083-2010 (Technical Requirements for Protective Face Mask for Medical Use), (3) YY 0469-2011 (Surgical mask), and (4) YY/T 0969-2013 (Single-Use Medical Face Mask). The announcement also summarizes production licensing and Quality Management System requirements for these devices.
  • The NMPA has also​ launched a page titled "Medical Device Registration Information in China" to help the public determine whether a domestic ​device or IVD pertaining to COVID-19 is registered.

Changing registration requirements for export of critical medical supplies

On March 31 the NMPA issued Announcement No. 5 of 2020, Export of Medical Devices for COVID-19. This states that Chinese companies must ensure that their new coronavirus detection reagents, medical masks, medical protective clothing, ventilators, and infrared thermometers have been registered with the NMPA in order to export to other markets. Manufacturers must provide a declaration to Customs to confirm that the exported products are registered with the NMPA and also meet the quality standards of the importing country; a template for this declaration is included as an annex to the announcement.

A subsequent announcement on April 25 from China’s Ministry of Commerce adjusted this requirement. From this point forward, manufacturers of the products covered in Announcement No. 5 must ensure that each product has been certified or registered by the country or region of import and is compliant with the relevant quality standards and safety requirements. Domestic regulatory approval is no longer required, although NMPA registration will still serve to show that a device is exported in accordance with Chinese quality standards. 

Many devices no longer eligible for emergency approval

​It appears that the NMPA is only approving some COVID-19 IVDs through the emergency registration route at this time, and other​ Class III devices may not be accepted for emergency approval. Additionally, some provinces (such as Henan, Zhejiang, and Hunan) have closed emergency approval for all Class II devices.

As a possible alternative for a faster review, interested manufacturers could try to confirm whether a province would accept their device for the “Green Channel” priority review route. Different provinces have varying requirements and criteria. 

Learn how other device markets are responding to COVID-19.

NMPA focuses on inspections of sterile and implantable medical devices

The NMPA published Announcement No. 34 of 2020 on April 14 in order to reinforce the supervision and inspection of sterile and implantable medical device companies in China, in conjunction with the prevention and control of COVID-19. Notably, these companies must complete and submit the relevant self-inspection forms (provided as attachments to the announcement)​ before the end of June.

According to the announcement, inspections will focus on "high-value medical consumables," devices used for the prevention and control of novel coronavirus epidemics (especially medical protective clothing, masks, and other large-scale products), single-use infusion equipment, etc. There will also be a focus on companies with multiple years of random sampling failures or serious defects in previous inspections; those who lack the appropriate certifications or training; those who fail to meet requirements for self-inspection; or any other companies for which serious security risks are identified. The announcement also outlines the key points to be verified in an inspection.

Provisions for documents that cannot be notarized

China’s Center for Medical Device Evaluation (CMDE) has issued Notice No. 13 of 2020, specifying arrangements for the submission of notarized documents, due to lockdowns and/or remote office arrangements in other countries that may make them difficult to obtain. Documents for the registration, modification, and renewal of imported Class II and III medical devices (or IVD reagents), as well as clinical trial approval applications, that cannot be notarized may be temporarily submitted with a signature by the (foreign) applicant or manufacturer. The signature must be accompanied by an explanation for the absence of the notarized documents and a promise to bear the corresponding legal responsibility. Additionally, the notarized documents must be submitted as part of the supplementary materials requested during the application review process.

Learn more about China NMPA medical device regulatory issues at Emergo by UL:

  • China NMPA medical device registration and approval consulting
  • Medical device clinical and testing requirements assessment for China
  • Process chart: NMPA regulatory approval for medical devices
  • Whitepaper: China NMPA medical device registration
  • Webinar: Medical device registration in China

Author

  • Timothy Herr

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