The compliance with the NMPA (CFDA) clinical trial requirements in China is getting more strictly audited and reinforced. On November 13th, NMPA (CFDA) issued the 2nd notification in 2018 for the upcoming clinical audit for two IVDs and eight medical devices companies. Foreign manufacturers, RSR from UK and Q-Med from Sweden are on the list. These audits will be conducted at 31 clinical sites (hospitals).
How to ensure IVD/Device Good Clinical Practice (GCP) complies with NMPA (CFDA) ever changing requirements? NMPA (CFDA) published "Draft IVD Clinical Trial Guideline for Feedback" on November 22nd, 2018. It specifies that IVD clinical trial sites must be listed on the NMPA (CFDA) filed institutions for Medical Device Clinical Trial Sites. In addition, it requires using fresh samples, instead of stored sample, and statistically significant sampling size. For more information on these changes please contact us at Info@ChinaMedDevice.com for an initial consultation.
Complete list of companies receiving the 2nd batch of clinical audits:
- RSR: Aquaporin-4 (AQP4) autoantibody kit
- Wantai Kairui: Antigen CA242 assay kit
- Q-Med: Sodium hyaluronate injection
- Wuhan Yunhe: Semiconductor laser therapeutic instrument
- Qingdao Zhonghao: Acellular porcine corneal stroma (APCS)
- Shanghai Jieshi: Perfluorooctanesulfonic acid (pfos) ophthalmic solution
- Shandong Huaan: Biodegradable Rapamycin-eluting coronary stent system
- Beijing Hongqiang Furui: Mid-infrared 1550nm therapeutic laser
- Jiangsu Huaxia: disposable pain relief bag
- Guanhao: Bone Repair Biomaterials
For our comments on the "Draft IVD Clinical Trial Guideline for Feedback", please click HERE.
For clinical sites in the 2nd batch of clinical audits, please email info@ChinaMedDevice.com.
Keep yourself updated with CFDA News Roundup, click HERE to opt-in. For market access newsletter, click HERE. For CRO services in China, click HERE.
About ChinaMed Device, LLC
ChinaMed Device, LLC (www.ChinaMedDevice.com), a Boston headquartered company, provides regulatory and commercialization turnkey solutions for western medical device, IVD, CDx and combination products to enter China. Our NMPA (CFDA) regulatory services include: regulatory strategy, RA, clinical evaluation report (CER), clinical trial, QA, GMP and post-market compliance. Our commercialization services include: market assessment research, reimbursement, partnership, and distribution qualification. We are a NMPA (CFDA) certified legal agent with offices in Boston and Beijing enabling us to service our clients 24/7.
------------------------------
Grace Fu Palma
China Med Device, LLC
MA, U.S.
gpalma@chinameddevice.com978-390-4453
www.chinameddevice.com------------------------------