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.
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 […]
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 […]