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  • ANVISAは、カスタムメイド医療機器を対象にした新たな規制を発表しました。
  • 商業化、輸入、製造等に関する要件が含まれる見込みです。
  • ANVISAでは、カスタムメイドや患者ごとに作られる機器に関する現行の「特別依頼」プロセスを一新する予定です。

Major Changes to Brazil Good Manufacturing Practice Requirements Announced

Update 09/12/2013: ANVISA has published modified information regarding Decree No. 8077/2013 without mentioning BGMP exemption, but stating that specific sanitary regulations will apply. In the future, Brazilian regulators may be more selective in determining BGMP requirements based on individual devices' risk profiles, but for now compliance with RDC 25/2009 is still required.

Le Brésil assouplit les exigences relatives aux Bonnes Pratiques de Fabrication Brésiliennes (BGMP) pour les fabricants en possession de la certification INMETRO

Par la présente, nous vous informons des nouvelles dispositions récemment adoptées par l’Agence nationale de surveillance sanitaire au Brésil (ANVISA).

Brazil Inspection Fees

Brazil’s National Agency for Sanitary Surveillance (ANVISA) has officially confirmed that inspection fees for Certificates of Good Manufacturing Practice and Quality Control (Brazil GMP) will