Asia Medical Device Registration

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Product registration in Asia can be complicated and tedious. Each country has its own product registration requirements and classification systems. 

 

Asia Harmonization Working Party (AHWP) was formed in 1999 to establish a harmonization requirement in the AHWP guidance based on GHTF/IMDRF. Each country will take reference from that guidance for their regulations. Due to the country concern topic, the authority will also incorporate their country specific requirements in their regulations.