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:
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:
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:
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:
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 firstname.lastname@example.org. 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.