CFDA Updates

June 29, 2017

CFDA Approves Novel Heart Valve Replacement Device

China’s Food and Drug Administration has approved a new-generation heart valve replacement product, which greatly reduces surgery time and increases survival rate. The J-Valve, an upgraded transcatheter aortic valve implantation […]
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 6, 2017

CFDA Updates: Draft of “Clinical Evaluation Basic Requirements for Clinical Exempt IVD Reagents” Issued, Along with the 2nd Batch of Clinical Exempt Class II IVD Reagents

On May 24,2017, CFDA issued the draft of “Clinical Evaluation Basic Requirements for Clinical Exempt IVD Reagents”. The 2nd batch of clinical exempt class II IVD reagents (130 reagents) have […]
June 6, 2017

CFDA Updates: Clinical Evaluation Requirements for Clinical Trial Exempt IVD Reagents (Draft)

According to Article 29 in the “Administrative Decree for the IVD Reagents Registration” (CFDA, No. 5), the clinical exempt IVD reagents will need the clinical performance evaluation based on the assessment of products’ intended use, interference factors, comprehensive literature review and other non-clinical-trial methods.