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ANVISA和INMETRO

ANVISA is part of the Ministry of Health of Brazil and is responsible for the pre-market and post-market control of all medical devices, in vitro diagnostic products and other health-related products such as pharmaceuticals, hygiene products, cosmetics, etc. Its role is equivalent to the FDA of the United States, China's CFDA. INMETRO, under the ministry of Development, Industry and Foreign Trade of Brazil, is responsible for the formulation and management of product certification and measurement principles, as well as the accreditation and management of related laboratories and certification companies.

INMETRO's new requirements

Only companies established in Brazil are eligible to be certification applicants; Existing test reports should not be valid for more than 2 years (4 years for large equipment, such as MRI and CT); A set of test reports is valid for only one manufacturing site. If more than one assembly site is involved, it will be treated as a separate series and will require separate laboratory tests. The scope of plant assessments has been increased to include additional requirements that must be validated on site

ANVISA和INMETRO

INMETRO's new requirements

International Projects

China Project

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Database

400-0569-812

Database

400-0569-812