Blogs

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 […]
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.

May 31, 2017

CFDA Update: More On Overseas On-site Inspections

Under CFDA Guideline Nos 14 and 218 issued in 2015, China targets sterile devices, implant and IVDs for overseas onsite inspection for registration and issuing manufacturing permit, including change order […]
May 30, 2017

Market Segment – China’s Overall Dental Market Annual Growth Rate Is 20-30%

Market Segment Snapshot:China’s overall dental market annual growth rate is at 20-30% with the implants annual growth rate goes an even faster pace at >30%. China Med Device https://chinameddevice.com/ performed […]