Coronavirus Spurs Emergency Device Approvals in China; Reveals Lessons for Manufactures to Speed Market Entry

While the Novel Coronavirus (COVID-19) has caused a tragic loss of life in China, the crisis demonstrates the flexibility of the country’s health agency. In just a couple of weeks, dozens of essentials detection kits, medical devices and supplies received accelerated regulatory approval.

Thankfully, the outbreak appears to be contained and could be over by April, according to Academician Zhong Nanshan in a February 11 Reuters interview. As the crisis winds down, this incident may have a variety of implications on medical device manufacturers, including lessons for expedited market entry, a greater push for electronic document submission and challenges to ongoing clinical trials.

While the Novel Coronavirus (COVID-19) has caused a tragic loss of life in China, the crisis demonstrates the flexibility of the country’s health agency. In just a couple of weeks, dozens of essentials detection kits, medical devices and supplies received accelerated regulatory approval.

Thankfully, the outbreak appears to be contained and could be over by April, according to Academician Zhong Nanshan in a February 11 Reuters interview. As the crisis winds down, this incident may have a variety of implications on medical device manufacturers, including lessons for expedited market entry, a greater push for electronic document submission and challenges to ongoing clinical trials.

Emergency Approvals for Devices and DiagnosticsOn January 27, the NMPA authorized the import of non-NMPA approved medical devices to combat COVID-19, provided the devices met certain standards.

“The Notice of Importing Non-NMPA Approved Medical Devices,” published by the Center of Medical Device Evaluation (CMDE), informs provincial counterparts to allow the import of non-NMPA approved medical devices to help contain the coronavirus as long as those devices have the following:

• FDA approval, CE Marking, or Japan approval;
• Testing report; and
• Solid Quality Management System (QMS)

The notice specifies that “the provincial NMPA shall cooperate with local departments of Industry and Information Technology, Health and Customs to ensure smooth importation and customs clearance. Provincial NMPAs shall issue the Certificate of Import License if needed.”

As of February 5, provincial NMPA offices granted Emergency Approvals to 72 medical devices, with a focus on protective supplies, ventilation devices and sterilization.Diagnostic devices benefited as well, as provincial NMPAs streamlined review procedures. For example. the First Novel Coronavirus Nucleic Acid Detection Kit moved from submission to approval in only two days.  On January 28, Jiangsu Province issued the Testing Report and granted Emergency Approval for the test kit. Within two weeks, National NMPA granted seven Emergency Approvals to devices employing the nucleic acid method of testing for the virus.

Amid the COVID-19 crisis, China NMPA has taken many measures to handle its insufficient medical resources. Along with emergency approval procedures and the importation of non-NMPA approved devices, expect additional reforms to be triggered by this crisis and potential new opportunities for medical device manufacturer to accelerate China registration:

• Promising prospects for biologic therapy, novel IVDs, Companion Diagnostics (CDx), Next-Generation Sequencing (NGS) instruments, big data, and AI diagnosis devices.  
• Accelerated approval of protective supplies, diagnostics for emergency use, and sterilization and ventilation devices aimed at this outbreak of coronavirus.
• Increased use of conditional approval and clinical experience data including Real-World Data (RWD). The conditional approval pathway has been applied to the seven manufacturers of coronavirus nucleic acid detection reagents and they obtained approvals in one week;
• More harmonization with international standards. Non-NMPA approved devices with FDA approval, CE Marking, or Japan approval can be imported to China under emergent situations. More international standards will be recognized by China.
• High-efficiency online office in China, covering Chinese regulatory authorities, hospitals, type testing centers, especially for E-submission to NMPA, Institutional Review Board (IRB)/Ethics Committee (EC) approval, Human Genetic Resources (HGR) filing under emergencies.

NMPA Mandates E-submissions
An unexpected side effect of this crisis has been the expedited use of E-submissions. Launched on June 24, 2019, the Electronic Regulated Product Submission (eRPS) system did not prohibit paper submissions. That changed on January 30 as NMPA issued a directive mandating eRPS use during the outbreak:

The “Notice of Modification of Application Acceptance and Consultation Services during Coronavirus Outbreak,” dated February 3, 2020, says the applicants who have obtained the CA (Certificate Authority) shall submit applications through the eRPS system.

The Notice explains that NMPA is to:

• Suspend onsite submission of paper documents related to initial and renewal registration; Applicants must submit documents via mail.
• Suspend face-to-face NMPA pre-consultations; Applicants shall call CMDE.
• Suspend face-to-face supplement phase evaluations; Applicants shall apply on CMDE website
• Suspend face-to-face meetings for Innovation Application, Priority Review, and Clinical Trial Application; Applicants shall contact CMDE and set up an E-meeting or conference call.

Clinical Trials Face New Challenges
The coronavirus outbreak will have a significant impact on clinical trials in China. Although the healthcare facilities are running properly and the usage of medical devices has not been affected, the burden on pulmonology departments and outpatients rose noticeably which could bring negative effects to the overall operation of hospitals.

In response, 206 hospitals issued “Special Measures Related to Good Clinical Practice” on February 13. Fudan Cancer Hospital, which worked with China Med Device on Innovation Device CT-Linac, a combination of CT and accelerator for radiotherapy, implemented several actions including:

• Principal Investigator (PI) shall decide if postponed follow-up visit or remote communication with subjects is needed; Deviation of follow-up method shall be reported to Ethics Committee
• Subjects are advised to conduct tests at a local hospital and keep complete information such as medical records and test results; the investigators will remotely review the results and send the drug to the subject; subjects must take all documents at the next visit.
• If a hospital visit is necessary, call the subjects in advance to visit. Ask if they have gone to the epicenter Hubei Province, and inform subjects they must remain the normal body temperature when visiting, must wear a mask, and make the visit arrangements in advance.
• Sponsors, Clinical Research Organizations (CROs) and Site Management Organizations (SMOs) shall respectively provide their employees with protective supplies.

Editor’s Note: If you are facing challenges due to the coronavirus crisis, China Medical Device has resources to help. Email us at [email protected] with the name of the hospital where your clinical study is or will be conducted and we will contact you to discuss the best options.

As hospitals divert resources to the coronavirus, manufacturers conducting clinical-trials of their medical devices could be affected by revised policies, such as:

• Decreased paperwork for IRB/EC approval, HGR filing, local NMPA filing, etc. Sponsors must submit electronically and use an E-signature.
• Transformed EC review, utilizing E-submission and remote meetings with committee members
• More frequent use of a database for patient registry and Adverse Event monitoring
• Increased remote supervision and decreased visits by Clinical Research Organization (CRO) staff to cut down service fees
• More Electronic Data Capture (EDC) applied to medical device clinical trials instead of paper CRF, etc.

As a qualified CRO, China Med Device can help overseas manufacturers perform type testing in China, manage clinical trials for registration and conduct post-market follow up studies. If you have any clinical trial data or real-world data outside of China, please do not hesitate to contact us at [email protected]. These data can be another clinical pathway for China registration instead of a clinical trial. Our medical experts will assess your clinical data and identify the most feasible pathway to save your time and money.