Brazilian Health Regulatory Agency (Anvisa) published the Resolution (RDC 348/2020), which established extraordinary and temporary rules to speed up the evaluation of new products by prioritizing the analysis of test registration requests for detection of the new coronavirus (SARSCoV-2).
I – Payment proof of the Health Surveillance Inspection Fee (TFVS) through the corresponding Brazilian Federal Tax Collection Form (GRU), or a fee exemption voucher;
II – Electronic application form provided by ANVISA
III – A technical dossier containing all required information for the corresponding risk class.
IV – For all imported products, a consularized declaration, accompanied by sworn translation, issued by the manufacturer within a maximum of two years, whenever there is not an express validity indicated in the document, authorizing the importer to represent and commercialize its product(s) in Brazil.
V – Proof of Certificate of Good Manufacturing and Control Practices issued by ANVISA, or proof of submission of GMP Certificate application.
III – A technical dossier
a) product description, containing the data listed below:
a.1) indication for use or intended use
a.2) detailed description of test method principle or instrument operating principles;
a.3) product risk class;
a.4) description of the product’s components and, when appropriate, description of the active ingredients of the components;
a.5) description of the commercial presentation and packaging (primary and secondary);
a.6) where applicable, for automated tests, description of the characteristics of the required or dedicated instrument;
a.7) where applicable, indication of the software to be used with the in vitro diagnostic product;
a.8) where applicable, description or complete list of the in vitro diagnostic product configurations/variations that will be available;
a.9) where applicable, description of accessories, other in vitro diagnostic products and any other product, which shall be used in combination with the target product; and
a.10) indication of the country(ies) in which the product(s) has/have been authorized or approved for commercialization
- b) product images (photographs, drawings or diagrams of the product or set of its components);
- c) product risk management report (risk analysis and risk reduction measures);
- d) where applicable, list of adopted technical standards;
- e) Certificate of Compliance issued by the Brazilian Compliance Evaluation System (SBAC), for instruments with compulsory certification, listed by ANVISA in specific regulations.
- f) performance studies, containing, when applicable:
f.1) biological samples
f.2) determination of metrological traceability of calibrator and control values
f.3) measurement accuracy
f.4) measurement precision
f.5) analytical sensitivity or detection limit
f.6) analytical specificity
f.7) high-dose prozone effect
f.8) measurement range (limits) or linearity range
f.9) definition of cut-off value
f.10) test procedure validation report
f.11) validation report of the cleaning and disinfection procedures for instruments that require direct contact with the patient or lay user
f.12) usability report for products intended for lay users
- g) product stability (except instruments)
- h) clinical performance, when applicable
- i) labeling and instructions for use (according with the requirements of Chapter V of RDC No. 36/2015)
- j) addresses of the manufacturing sites, including the sites of stages that are outsourced or contracted by the legal manufacturer;
- k) manufacturing processes with production process flowcharts describing manufacturing phases or stages required to produce a finished product, including control stages in process and finished product testing, identifying manufacturing sites, when applicable.
IV – Consularized declaration
- a) manufacturer company name and complete address;
- b) importer company name and complete address;
- c) express authorization for the importer to represent and commercialize the product(s) in Brazil;
- d) awareness of and compliance with the Good Manufacturing Practices for Medical Products requirements established by the Collegiate Board of Directors Resolution – RDC no. 16, of March 28th, 2013.
V – Proof of Certificate of Good Manufacturing
Certificate of Good Manufacturing Practices
R$ 73,000.00 Brazilian Reais
Product registration fee at ANVISA
Depends on the size of the company that registers the product.
*Companies with the size of Global Regulatory Partners:
R$ 14,000.00 Brazilian Reais.
About Global Regulatory Partners
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices and pharmaceutical companies globally. GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and Argentina. GRP helps many life science companies register their products in different countries in compliance with local regulations. To learn more, please contact us at firstname.lastname@example.org