CFDA Updates

January 30, 2018

2018 CFDA Changes in IVD Product Classification

On December 29th 2017, CFDA issued Circular No. 226 of 2017, redefining the attributes and categories of IV diagnostic reagent products such as allergens, FACS, immunohistochemistry and in situ hybridization. […]
January 29, 2018

CFDA Must Read—— New Guideline for Medical Device Oversea Inspection

The CFDA is putting greater emphasis on the quality system management and post-market compliance of overseas medical device manufacturers. In the past, very rarely did the national CFDA make public […]
January 26, 2018

Key Aspects to Expedite Your Medical Device’s Approval with CFDA

After a major overhaul in 2014, the CFDA “Regulations on the Supervision and Administration of Medical Devices” have been focusing on registration quality management system verification with higher requirements, compared […]
January 26, 2018

Weekly CFDA Updates (Jan 14-20)

China Med Device publishes weekly CFDA updates covering medical device regulation, guideline, standard, recall, adverse event alert, recall, registration approval. Below are the CFDA updates from January 14 to January […]
January 24, 2018

CDFA Released Technical Guidelines for The Registration of Animal-Derived Medical Devices

On January 5th, 2018, CFDA released a “Medical Device Clinical Trial Design Guidelines.” Here is a summary of the scope, purpose and coverage of this document.   This guideline is […]