Mercosur
Mercosur (in Spanish), Mercosul (in Portuguese), is a South American trade bloc established in 1991 Its full members are Argentina, Brazil, Paraguay and Uruguay. Associate countries are Bolivia, Chile, Colombia, Ecuador, Guyana, Peru and Suriname.
MECOSUR developed the basic regulations - comparable to European Directives - for medical devices which had to be transposed into national legislations by the member states.
The basic regulation for the registration of medical devices is the GMC 40/00.
Argentina
Argentina as one of the Mercosur member countries transposed the GMC 40/00 into the national legislation.
General
The Importer is obliged to register the devices he intends to sell with ANMAT.
Classification
Similar to the European classification prior to 2007 with four classes:
Class I, II, III, IV
Product Registration
Manufacturers of class II,III,IV need to submit registration dossiers to ANMAT for review and integration into the RPPTM (Argentinian register of medical devices).
For class I devices the documentation is simplified.
Quality System
ANMAT requires the proof of an existing quality system, but does not perform audits at foreign manufacturers.
Specifics
The label of the device needs to identify if the products are free for sale or restrict to specific condition such as professional use only.
UDI Code is mandatory.
Brazil
One of the MDSAP participating countries and member of the Mercosur.
General
A partner acting as registration agent and importer is required.
Classification
Similar to the European classification prior to 2007 with four classes:
Class I, II, III, IV
Product registration
ANVISA registration ("REGISTRO") is required for Class III,IV Products.
Class II products require a listing with ANVISA ("CADASTRO").
As of 2019-04-30 the procedures for class I products were further simplified, they only require a "NOTIFICAÇAO".
Quality System
Manufacturers of Class III and IV products need to follow the RDC 16:2003 and implement a quality system (BPF) which can be covered e.g. by MDSAP audits.
Specifics
Some products (including all electro-medical devices) require the product certification "INMETRO" upfront.
Further Information
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| Content of this website was last updated 2019-10-22 |