Brandwood Biomedical has established expanded operations in Beijing to support the continuing growth of our client base seeking services in China. We provide efficient and transparent local submission management and independent license holding services for international manufacturers seeking CFDA approvals.
Archives for October 2015
China CFDA continues its ambitious reform program. Director of Registrations Wang Zhexiong set out a five point reform plan combining updated and streamlined back office processes with updated technical standards and greater transparency of decision making.
Speaking at the China International Medical Device Regulatory Forum (CIMDR) in Guangzhou on 24 September, China Food and Drug Administration (CFDA) Deputy Commissioner Jiao Hong set out the agency’s plans for an international medical device manufacturing audit program. CFDA intends a growing foreign audits program commencing second half of 2015. What does this mean for exporters of devices to CHina?
Since the 2014 update to Chinese regulations, software is now clearly and unambiguously included in medical device regulation. The Chinese classification guidance included adjustments to software classification, raising all standalone medical device software to Class II or above. On 5th August, CFDA published its Software Registration Technical Review Guidance. The implementation of this guidance has raised some […]
OK here’s a quick quiz: which is the only part of the FDA’s Quality System Regulations apply to a manufacturer before they have received 510(k) clearance? Pat on the back for all who answered “21CFR 830.30” – that’s the Design Control regulation, and FDA requires that manufacturers comply with this regulation during the product development […]