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

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

Picture by BBC News

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 info@ChinaMedDevice.com 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 info@chinameddevice.com. 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.  

Editor’s Note: For more information on the Emergency Approval pathway, including the best options to register your device or IVD, feel free to email us at info@ChinaMedDevice.com. We can help you identify the product codes, compare your standards with NMPA-complied ones, submit type testing report if needed, register the products with right provincial NMPA, and ensure smooth customs clearance.

About ChinaMed Device, LLC 

ChinaMed Device, LLC (www.ChinaMedDevice.com) provides regulatory and commercialization turnkey solutions for medical device, IVD, CDx, and combination products in China. As a qualified NMPA (CFDA) legal representative with offices in Boston and Beijing, we can represent manufacturers for the complete product life cycle without their need to create a local entity in China. Our NMPA (CFDA) regulatory services include strategy, registration, local type testing, product technical requirement (PTR), clinical evaluation report (CER), clinical trial, GMP and post-market surveillance (AE, recall, inspection, etc.). Our commercialization services include market research, reimbursement, partnership strategy, and distribution qualification.