Thai Cab­i­net Ap­proves Draft Amend­ment to the Med­i­cal De­vice Act

Thai-American Business (T-AB) Magazine - - Legal Updates -

On Novem­ber 3, the Cab­i­net ap­proved in prin­ci­ple the draft amend­ment to the Med­i­cal De­vice Act (“Draft Amend­ment”) as pro­posed by the Min­istry of Pub­lic Health ( MOPH).

The Draft Amend­ment aims to pro­vide bet­ter pro­tec­tion to con­sumers, en­sure com­pli­ance with the ASEAN Agree­ment on Med­i­cal De­vice Di­rec­tive ( AMDD) and in­ter­na­tional guide­lines, and re­lax cer­tain reg­u­la­tions to as­sist med­i­cal de­vice oper­a­tors. Sig­nif­i­cant amend­ments un­der the Draft Amend­ment in­clude:

• re­vis­ing the def­i­ni­tion of “med­i­cal de­vice” and adding def­i­ni­tions of “ac­ces­sories” and “no­ti­fi­ca­tion ap­pli­cant;” • rewrit­ing the clas­si­fi­ca­tions of groups of med­i­cal devices or med­i­cal devices ac­cord­ing to the risk as­sess­ments; • as­sist­ing oper­a­tors by re­vok­ing cus­toms ver­i­fi­ca­tion mea­sures in the case of med­i­cal devices ex­port; • re­vis­ing the time­line of the ap­pli­ca­tion process, and re­vis­ing ad­ver­tise­ment re­stric­tions; • adding a pro­vi­sion on penalty for the no­ti­fi­ca­tion ap­pli­cants, as well as in­creas­ing the penalty to be com­pat­i­ble with the present en­vi­ron­ment.

For more in­for­ma­tion con­tact Baker & Mcken­zie at peer­a­pan. tung­suwan@ bak­erm­cken­zie. com.

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