Medical Device Regulatory Requirements in South America Countries such as Brazil, Argentina, Chile and other MERCOSUR members

Mercosur


Mercosur (in Spanisch), Mercosul (in Portugie-sisch), ist die abgekürzte Bezeichnung für den „Gemeinsamen Markt Südamerikas“  der bereits 1991 gegründet wurde.  Es handelt sich hierbei um einen Binnenmarkt mit mehr als 260 Millionen Menschen (Stand 2006).

Die vollwertigen Mitglieder sind Argentinien, Brasilien, Paraguay und Uruguay. Assoziierte Länder sind Bolivien, Chile, Colombian, Ecuador, Guyana, Peru und Suriname.

 

MECOSUR hat die grundlegenden Regularien für die Registrierung von Medizinprodukten geschaffen - vergleichbar mit Europäischen Richtlinien - die von den Mitgliedsstaaten in nationales Recht umgesetzt werden mußten.

 

Die maßgebliche Vorgabe für die Registrierung der Medizinprodukte ist die GMC 40/00.

 

MERCOSUR WEBSITE

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 reduced.

 

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