From regulatory submission to approval, it only took 2 days for a coronavirus nucleic acid detection kit to go to market. On January 28, Jiangsu provincial NMPA issued the Test Report for the First Novel Coronavirus Nucleic Acid Detection Kit, describing the procedure of expedited regulatory process in the coronavirus pandemic:
12:25 pm, Jan 26 Received Type Testing Application for First Novel Coronavirus Nucleic Acid Detection Kit, submitted by Shuoshi Bio
12:35 pm, Jan 26 Type Testing Emergency Team initiated work. Confirmed testing capability based on PTR (Product Technical Requirement) submitted by manufacturer, and requested positive control samples.
9 am, Jan 27 Received positive control samples and conducted type testing
10 am, Jan 27 Finished type testing
8 am, Jan 28 Data compiling
10 am, Jan 28 Testing Report presented. Emergency Approval granted
By Jan 28, Jiangsu provincial NMPA finished Emergency Type Testing for two medical protective mask manufacturers; received one protective clothing application; and had consultation call with 4 others.
For our post on three fast-track channels, please click HERE.
How Do Overseas Manufacturers Qualify
China national NMPA transferred the regulatory authority to the provincial ones, opening green line for overseas medical products amid the virus outbreak.
NMPA informed local counterparts on Monday Jan 27 to “allow import none -NMPA approval devices but have FDA approval, CE mark, or Japan approval, to help conquer 2019 Novel Coronavirus (‘2019-nCoV’)”.
In the Notice national NMPA further stated that overseas products can be filing, instead of “registering”, for provincial approval. In China, “filling” is for Class I devices which does not require clinical trial.
What Supplies are Needed
Shanghai government issued an online notice on Monday Jan 27, listing the urgent needs on supplying below products:
- Medical protective clothing with rubber strip (piece)(complying with GB19082-2003)
- Medical protective mask (N95, complying with GB19083-2010)
- Surgical mask (complying with YY0469-2011)
- Disposable Medical Cap
- Disposable Medical Shoe Cover
- Protective helmet
- Disposable isolation gown
- Nitrile gloves
- Sterile gloves
- Non-contact infrared thermometer
If you want to export medical equipment and supplies via China provincial emergency pathway, please contact info@ChinaMedDevice.com.
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.