At the March 2018 Shanghai meeting of IMDRF, new work item proposals from China on GCP practices and the update of technical standards were approved. These seemingly routine administrative efforts mask a radical change – with China for the first time taking the lead on IMDRF harmonization efforts and seeking to promulgate its own approaches into global regulation. We take a look at what’s really going on.
Presentations from CFDA leadership at the CIMDR meeting in Hangzhou point to continuing reform in Type Testing requirements, clinical trials supervision, device classifications and review processes. We take a look at the key messages from CFDA on China’s regulatory reform program.
After successfully completing its pilot introduction, the Medical Device Single Audit Program (MDSAP) has now been selected by a range of Medical Device Manufacturers as an option to meet their Regulatory obligations. In this blog we will discuss what is to be expected from the program and how MDSAP currently fits in the overall Regulatory landscape.
At the Irish Medtech Global Access conference in Galway this week, a common theme emerged: planned transitional arrangements schedules for ISO 13485:2016, the European Medical Device and IVD regulations and the MDSAP audit program will combine to create a Perfect Storm which will challenge their resources of Regulatory agencies and assessment bodies and manufacturers alike. You may think things are getting busy now, but in reality we are in the calm before the storm. Are you ready?
As regulations tighten – regulators get busier and backlogs and delays are increasing. In this environment, a single audit program not only reduces audit workload – it can offer speedier market access.
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?