Adjustment of Notarization Documents for Some Medical Device Registration Applications

On April 15, 2020, CMDE released a notice of adjusting the notarial documents for some of the medical device registration applications. This adjustment mainly focuses on the submission time and form considering the global spread of COVID-19, e.g., the notarization dossiers could be submitted during the supplementary phase due to the overseas notarization process delayed. NMPA will accept the e-notarization form from overseas manufacturers. Bradynuoen can provide the turnkey solutions to manufacturers for China entry.

Link: https://www.cmde.org.cn/CL0004/20760.html

About China Med Device

ChinaMed Device provides regulatory and commercialization turnkey solutions for western medical device, IVD, CDx and combination products to enter China. As a certified NMPA (CFDA) legal agent with offices in Boston (China Med Device) and Beijing (Bradynuoen), we can represent overseas manufacturers for the complete product life cycle without their need to set up local entity in China. Our NMPA (CFDA) regulatory services include: RA, regulatory strategy, regulatory submissions, clinical evaluation reports (CER), clinical trials, QA, GMP and post-market compliance. Our commercialization services include: market assessment research, reimbursement, partnership strategies, and distribution qualification.

Offices:

China Med Device, Boston, US

Bradynuoen, Beijing, China

Address: Rm 1501-1502, East Ocean Centre, Jianguomen, Beijing, China

Tel: +86 10 65155991, +86 18600392020

Email: info@chinameddevice.cn

Website: www.chinameddevice.cn