Blogs

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 CT Medical Equipment Market Growing at a Rapid Pace

According to the 2016 China CT Medical Equipment Market Research Reportpublished by the Chinese Association of Medical Equipment in May 2017, the CT market ownership (the number of the registered […]
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 […]
June 8, 2017

NuvOx Pharma, a China Med Device Client, Has Won the 1st Place As The Most Valuable Start-Up Company

Congratulations to NuvOx Pharma, a China Med Device client, for winning the 1st place of the start-up companies with the most investment value, out of 46 biopharma companies at the […]