Blogs

June 23, 2017

Market Analysis: China’s Cardiovascular Device Market

As the No. 1 cause of death worldwide, mortality from cardiovascular disease in China is also increasing significantly. In Beijing, for example, the total loss of cardiovascular disease life expectancy […]
June 21, 2017

China Market Flash: Venus Medtech Acquires InterValve

China’s Venus Medtech acquired U.S. company InterValve to create a systematic TAVR treatment and strengthen its global expansion. Venus Medtech announced in this month that it has purchased U.S. Company […]
June 19, 2017

CFDA Updates: China Joins ICH

ICH Assembly approved the China Food and Drug Administration (CFDA) as a new Regulatory Member, and Pharmaceutical Inspection Co-operation Scheme (PIC/S) as a new Observer. The International Council for Harmonisation […]
June 14, 2017

CFDA issued the revised version of “Passive Implantable Medical Device Shelf Validity Period Registration Guideline”

On May 26th, CFDA issued a guideline of shelf validity period for passive implantable medical device.This guideline is a general requirement for passive implantable medical equipment shelf validity period and does not address other technical requirements.

The guideline is the revised version of “Passive Implantable Medical Device Shelf Life Registration Guideline” (CFDA, 2011)

Highlights of this revision:

1)     Changed Shelf Life to Shelf Validity Period

2)     Adjusted some wording

3)     Modified the definition of implanted medical equipment, consistent with the definition in "Medical Device Classification Regulation" (CFDA, No. 15).

June 14, 2017

China In-Vitro Diagnostics (IVD) Market Expected to Triple by 2022

IVD China MarketChina In-vitro diagnostics market is expected to be tripling its market size by the end of 2022 from 2016, according to a new report published by Research And […]