Background

INMETRO is the short form of the National Institute of Metrology, Standardization and Industrial Quality Brazil. The electrical and electronic products in the scope of compulsory certification required to have mandatory mark of INMETRO and a third party certification logo accredited by INMETRO (OCP) to enter and to be commercialized in Brazil.

According to Brazil regulation RDC 27/2011, active medical device are within the control scope, which must obtain INMETRO certificates before entering the Brazil market, and the certificates shall be submited to Brazilian Health Surveillance Agency (ANVISA) for review and registration to place the products on the market.

INMETRO mark issued by Intertek

INMETRO standards for medical device:

The procedure for medical device to apply INMETRO:

• Local product sampling & testing: IEC standard
• Local factory Inspection: ISO system auditing
• Document / report review
• Issuing certificate
• Annual monitoring factory inspection

Intertek Brazil INMETRO accreditation Scope

In April 2013, Intertek Brazil laboratory was accredited to issue INMETRO certification (OCP 0090) to the following products:

• Household electrical appliances  60335 (compulsory certification)
• IT products 60950 (voluntary certification)
• Medical Device 60601 (compulsory certification)

Intertek OCP mark

Intertek service

Intertek provides complete service for medical device including testing, certification and auditing covering CE, CB and ETL certifications, IEC 60601 3rd-edition testing, ISO13485, ISO14971 and QC080000 , FDA consulting, CFDA registration, etc. For more information, please contact us.