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How to Speed up INMETRO Certification for Brazil Market Accessing

2014-11-17 中文阅读版式订阅 +

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标示

INMETRO mark issued by Intertek

INMETRO standards for medical device:

1.ABNT NBR IEC 60601-1:1997	26.ABNT NBR IEC 60601-2-34:1997
2.ABNT NBR IEC 60601-1:2010	27.ABNT NBR IEC 60601-2-35:2006
3.ABNT NBR IEC 60601-2-2:2001	28.ABNT NBR IEC 60601-2-36:2006
4.ABNT NBR IEC 60601-2-3:1997	29.ABNT NBR IEC 60601-2-37:2003
5.ABNT NBR IEC 60601-2-4:2005	30.ABNT NBR IEC 60601-2-38:1998
6.ABNT NBR IEC 60601-2-5:1997	31.ABNT NBR IEC 60601-2-40:1998
7.ABNT NBR IEC 60601-2-6:1997	32.ABNT NBR IEC 60601-2-43:2004
8.ABNT NBR IEC 60601-2-7:2001	33.ABNT NBR IEC 60601-2-45:2005
9.ABNT NBR IEC 60601-2-10:2002	34.ABNT NBR IEC 60601-2-46:2000
10.ABNT NBR IEC 60601-2-12:2004	35.ABNT NBR IEC 60601-2-47:2003
11.ABNT NBR IEC 60601-2-13:2004	36.ABNT NBR IEC 60601-2-49:2003
12.ABNT NBR IEC 60601-2-16:2003	37.ABNT NBR IEC 60601-2-50:2003
13.ABNT NBR IEC 60601-2-18:2002	38.ABNT NBR IEC 60601-2-51:2003
14.ABNT NBR IEC 60601-2-19:2000	39.ABNT NBR IEC 60601-1-1:2004
15.ABNT NBR IEC 60601-2-20:1998	40.ABNT NBR IEC 60601-1-2:2006
16.ABNT NBR IEC 60601-2-21:2000	41.ABNT NBR IEC 60601-1-3:2001
17.ABNT NBR IEC 60601-2-22:1997	42.ABNT NBR IEC 60601-1-4:2004
18.ABNT NBR IEC 60601-2-24:1999	43.ABNT NBR IEC 61689:1998
19.ABNT NBR IEC 60601-2-25:2001	44.ABNT NBR ISO 7785-1:1999
20.ABNT NBR IEC 60601-2-26:1997	45.ABNT NBR ISO 7785-2:2004
21.ABNT NBR IEC 60601-2-27:1997	46.ABNT NBR ISO 9919:1997
22.ABNT NBR IEC 60601-2-28:2001	47.ABNT NBR ISO 11195:2000
23.ABNT NBR IEC 60601-2-30:1997	48.ABNT NBR ISO 9680:2001
24.ABNT NBR IEC 60601-2-31:1998	49.ABNT NBR ISO 6875:1998
25.ABNT NBR IEC 60601-2-32:2001	50.ABNT NBR ISO 8835-2:2010

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)

OCP标志

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.