Medical device regulatory affairs requires full time (or overtime) attention due to the myriad of new regulations /changes underway and/or forthcoming (MDR and IVDR are prime examples).
For medical device companies who also have to access to Asia region, the region does not have an equivalent of CE for Europe. This means that medical device companies have to submit to each and every regulatory agency for the Asia region (from China, Taiwan, Japan, South Korea, Australia/NZ and to each ASEAN country).
As for ASEAN countries, each country has a different pace of adoption and rollout of AMDD.
DH RegSys Regulatory Affairs team has and will continue to help our clients from multi-directions including
CE and US FDA approval
China NMPA approval
major ASEAN countries like Indonesia, Thailand, Vietnam, Philippines, Malaysia
