Uncategorized

March 18, 2020

NMPA Roundup February Coronavirus Special Issue

Amid the novel Coronavirus (COVID-19) outbreak, we deliver the Coronavirus Special Roundup to give you insights on the measures China NMPA has taken to handle its insufficient medical resources and […]
March 13, 2020

Practical Lessons for Coronavirus Related Products Fast Track Clearance in China

Wednesday, March 18, 2020 | 12:00 pm – 12:45 pm ETIn response to the Novel Coronavirus (COVID-19) outbreak, China regulatory agencies issued over 70 Emergency Approvals of medical devices, including diagnostic […]
February 19, 2020

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

While the Novel Coronavirus (COVID-19) has caused a tragic loss of life in China, the crisis demonstrates the flexibility of the country’s health agency. In just a couple of weeks, […]
December 16, 2019
Medical Device Classification & Registration in China

Medical Device Classification & Registration in China – 4 Things You Must Know

You may find it complicated and confusing when trying to navigate through China’s medical device classification, registration and clinical trials process. In addition, to make the matters worse, specific regulatory […]
December 13, 2019

Real World Data Clinical Guideline Published Today; China Med Device Pioneered in the Program

Pic: China Premier Li Keqiang visited the Hainan International Medical Tourism Pilot Zone on Mar 25, 2019. NMPA issued the “Guideline on Real World Data (RWD) Used in Medical Device […]