September 30, 2020

China NMPA Delayed UDI Implementation Date to Jan 1st, 2021

NMPA issued a notice today to delay the UDI implementation date. The first batch of medical devices have changed from October 1st, 2020 to January 1st, 2021. The notice adjusted […]
September 30, 2020

Mandatory Fields for China NMPA UDI Database Filing and New Rules

Last year, NMPA issued a number of UDI related policies regarding the UDI implementation. There is a UDI database portal (https://udi.nmpa.gov.cn) established which includes sections of Filing entrance, UDI regulations, […]
August 6, 2020

NMPA approved BRAF mutation detection kits

Oncology biomarker testing, as an important tool to guide the treatment of targeted therapy, has been one of the hottest areas for IVD manufactures world-wide. BRAF gene mutations are one […]
June 30, 2020
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CMD New Webinar! Learn China Mandatory Period Risk Evaluation Report (PRER) and the latest PMS Requirements in China NMPA and US FDA

Thursday, July 9, 2020 | 12:00 pm – 1:10 pm ET Register Now! China has been increasing its surveillance on post market monitoring with more regulations and random inspections both […]
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 […]
December 11, 2019

16 Devices Recalled in November; One Class I Recall

NMPA announced Recall Notices for 16 imported medical devices in November. Class I recall (the most serious): Edwards Lifesciences: Aortic perfusion cannula Class II and Class III recall: GE: Patient […]
December 5, 2019
Medical Device GMP in China

GMP for Medical Devices in China – A Quick Guide

Striving to meet good manufacturing practices (GMP) for medical devices in China can be challenging. The following article will provide answers to the most common questions about GMP for medical […]
November 22, 2019

NMPA Focuses on 3D Printed Device: Five Guidelines Issued in Three Months

NMPA published five guidelines for 3D printed devices from August to October 2019: Registration Guideline on 3D Printed Implantable Bone, Joint and Oral Hard Tissue Registration Guideline on 3D Printed […]