Roland chung
Trusted Information Resource
Hello folks,
In the Brazil, as I know, there are certification process (INMETRO) and registration process (ANVISA) set for the medical device approval.
But I could not understand the INMETRO and ANVISA very well. I would like to raise some questions. Any comments are highly appreciated.
1) INMETRO is not only for medical device, it is also suitable for ordinary electrical products. Am I right?
2) ORDINANCE No. 350/2010 states that INMETRO is voluntary certification, except for products for which the Regulation Agency, Anvisa,
requires compulsory certification by means of the IN/Anvisa in effect. I want to know that where can I get the regulation of ANVISA? I could not find something in the www.anvisa.gov.br/eng/index.htm
3) I am wondering if all of the Medical Electrical Equipments are under the mandatory certification. I was told that if the standards are mandatory then the certification is compulsory. It seems that ABNT NBR IEC 60601 series are mandatory.
4) Can I skip the INMETRO certification and apply for the ANVISA registration directly? If there is an official document to explain this issue?
5) I was also told, the ANVISA could only be handled by UL Brazil. I am totally confused. As I know, certification bodies should be involved in the INMETRO process. But ANVISA can be done by Registration Offices and/or Legal Representers or Importers.
Thanks and regards,
Roland
In the Brazil, as I know, there are certification process (INMETRO) and registration process (ANVISA) set for the medical device approval.
But I could not understand the INMETRO and ANVISA very well. I would like to raise some questions. Any comments are highly appreciated.
1) INMETRO is not only for medical device, it is also suitable for ordinary electrical products. Am I right?
2) ORDINANCE No. 350/2010 states that INMETRO is voluntary certification, except for products for which the Regulation Agency, Anvisa,
requires compulsory certification by means of the IN/Anvisa in effect. I want to know that where can I get the regulation of ANVISA? I could not find something in the www.anvisa.gov.br/eng/index.htm
3) I am wondering if all of the Medical Electrical Equipments are under the mandatory certification. I was told that if the standards are mandatory then the certification is compulsory. It seems that ABNT NBR IEC 60601 series are mandatory.
4) Can I skip the INMETRO certification and apply for the ANVISA registration directly? If there is an official document to explain this issue?
5) I was also told, the ANVISA could only be handled by UL Brazil. I am totally confused. As I know, certification bodies should be involved in the INMETRO process. But ANVISA can be done by Registration Offices and/or Legal Representers or Importers.
Thanks and regards,
Roland