The regulatory role of anvisa has been intensive since. Medicamento rdc 6014 principio ativo rdc 452012 estabilidade excipientes embalagem rdc 7109 rotulagem rdc 4709 bula estudos in vitro rdc 3110 eqfar re 012005 estabilidade rdc 89903 validacao rdc 58 impurezas nt 03 dissolucao estudos in vivo re 0915 ddcm re 1170 be bpf rdc 1710 27. General overview of the brazilian regulatory framework 3. Brazil medical device regulations anvisa guidelines. Article 4 what material should be studied, article 5 what condition must be used and article 6 what results are acceptable and how their use in sim development. Mar 31, 2016 anvisa rdc 532015 has specific requirements for fds at its core. Farmcia e drogaria anvisa droga vegetal notificada conforme rdc 1010.
The regularized products in accordance with resolutions rdc no. Jul 06, 2016 on july 4th, anvisa published the document named questions and answers of the resolution rdc 532015 and guide n. With more than 10 years of experience in medical device regulatory and quality affairs, his expertise includes anvisa registration submissions and quality management system implementation and audits to rdc 16, iso 485, iso 9001, fda qsr, and other qms standards. Ministerio da saude pagina inicial da anvisa anvisa. Requirements for proof of gmp for registration processes of healthcare products en en pt. Brazil, the largest country in south america, has become the second largest pharmaceutical market in the emerging world. The document brings 47 questions and answers about degradation. These requirements are described in articles as summarized in table 1. Article 3 distributors and storage agents of medical devices and in vitro diagnostic devices shall. Brazil, anvisa, regulatory, registration, resolution, health surveillance, public. Requirements for economic information report en en pt.
A guide for importing medical equipment into brazil 1. Anvisa questions and answers of the resolution rdc 532015. Pdf, microsoft word or excel, each file can not exceed the size of 14 mb. Regulamentacao e implantacao da cosmetovigilancia no brasil. Rdc 302008 api registry portuguese rdc 572009 api marketing authorization english rdc 452012 api stability studies english rdc 692014 api gmp portuguese normative instruction in 152009 list 1 of apis subject to marketing authorization english. A guide for importing medical equipment into brazil. Resolution rdc5315 introduced in 2015 has provided. Resolution rdc n 2112017 changes the expiration date.
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