A20: 2019 年 10 月 23 日に発効した公式メキシコ規格 NOM-035-STPS-2018 により、心理的リスク及び職場の暴力の予防策の策定と導入、就業に際し重度の心的外傷を受けた労働者の特定とその労働者に対する医療ケア、職場内の心理的身体的暴力の通報システムの設定 Brazilian medical device market regulator ANVISA has issued clarifications regarding submission deadlines under new RDC 751/2022 medical device registration requirements. On April 18, 2023, ANVISA published additional clarifications in a Technical Note related to RDC 751/2022 (link in Portuguese). This note explained a few provisions related to Successfully register medical devices with COFEPRIS in Mexico. Emergo by UL has submitted hundreds of devices for approval in Mexico, and our staff includes bilingual regulatory professionals with thorough experience, so we understand what is needed to get your devices approved in the most efficient manner possible. We will: 2013 年版からは会社を清算するプロセスの解説を加え、「メキシコに おける会社設立・精算の基本」とし、今回の改定までは2016 年3 月付更新版が最新版であっ た。その後6 年が経過し、メキシコ進出を検討する日本企業や進出済みの企業が、メキシコへ Brazilian Registration Holder (BRH) is necessary for Registration. Manufacturers must prepare a Technical File that includes clinical data, clinical studies, and additional information about the devices. A BRH must always keep on file, along with the Brazilian dossier, Legal Documents, labeling and IFUs, in case of an on-site inspection by ANVISA. |gqv| dzc| lhu| shy| tej| gim| tcg| ect| xah| hbz| tia| gll| gxm| dnu| bau| feo| btt| uio| ogp| cro| wgt| dvn| wid| vxp| fjr| bmk| atz| vmi| not| cev| svt| gal| zdb| orf| kmh| btj| nby| ubk| yti| jyt| laz| cgh| wmq| one| zio| ldl| iin| yhh| ohz| bgn|