Medical Device News INMETRO (Brazil) Certification for Syringes, Needles and Infusion Sets

Marcelo

Inactive Registered Visitor
Hello all

Continuing the trend of Anvisa using INmetro certification as a means to verify some claims of safety and efficacy of medical devices, Inmetro published last week 3 new regulations - certification for syringes, needles and infusion sets.

The certification process uses Type 5 (the same as medical equipment certification) or type 7 (batch) iso certifications ans will required prior to registrations/cadastre of these devices. They also uses ISO standards for type testing.

In portuguese, on the following links:

Portaria INMETRO / MDIC número 501 de 29/12/2011 - Requisitos de Avaliação da Conformidade para Agulhas Hipodérmicas Estéreis para Uso Único e Agulhas Gengivais Estéreis para Uso Único

Portaria INMETRO / MDIC número 502 de 29/12/2011 - Requisitos de Avaliação da Conformidade para Equipos de Uso Único de Transfusão, de Infusão Gravitacional e de Infusão para Uso com Bomba de Infusão

Portaria INMETRO / MDIC número 503 de 29/12/2011 - Requisitos de Avaliação da Conformidade para Seringas Hipodérmicas Estéreis de Uso Único
 
M

maitre

Thanks Marcello for this information.
Looks like we have to expect a bunch of other products requiring the certification in the next future, isn't it?
How do I find the OCB that has the equipment performing the tests?
The scopes may just say "non-active products"...Can I find a comprehensive list of medical devices with mandatory INMETRO Certification?

I also found this N° 162 of 2012 (RTAC001804.pdf) on breast implants... Do the OCB provide tests on the breast implants?
 

jiligan

Involved In Discussions
Hello all

Continuing the trend of Anvisa using INmetro certification as a means to verify some claims of safety and efficacy of medical devices, Inmetro published last week 3 new regulations - certification for syringes, needles and infusion sets.

The certification process uses Type 5 (the same as medical equipment certification) or type 7 (batch) iso certifications ans will required prior to registrations/cadastre of these devices. They also uses ISO standards for type testing.
Hi Marcello,
Thank you for the links! I am still unsure of the requirement for the INMETRO certification for the syringes in our gastrostomy feeding tube kit. We have two syringes in our kit, neither are hypodermic. One syringe is for administering feed, medication and decompression, the other syringe is for balloon inflation or administering feed/medication. Both syringes screw directly to a port in the feeding tube. The kit is sold sterile. Is there any difference in the requirement for the INMETRO certification between the hypodermic syringes and the syringes found in our kits, or do all syringes require this certification?

Thank you for all your help!!!
 
Last edited by a moderator:

Marcelo

Inactive Registered Visitor
Hi Marcello,
Thank you for the links! I am still unsure of the requirement for the INMETRO certification for the syringes in our gastrostomy feeding tube kit. We have two syringes in our kit, neither are hypodermic. One syringe is for administering feed, medication and decompression, the other syringe is for balloon inflation or administering feed/medication. Both syringes screw directly to a port in the feeding tube. The kit is sold sterile. Is there any difference in the requirement for the INMETRO certification between the hypodermic syringes and the syringes found in our kits, or do all syringes require this certification?

Thank you for all your help!!!

The certification if for hypodermic syringes, so in principle, if your devices are not hypodermic, they may not require certification. But the best way to be really sure is to ask ANVISA or an OCP.
 

Mallappa

Involved In Discussions
Hello everyone,

It would be very helpful and I would really appreciate if you could answer few questions of mine in this regards. Please see below the list of questions for your reference.

Product in Scope: Blood Glucose Monitoring System

Blood Glucose Monitoring System is composed of following part.

1) Meter​
2) Strip​
3) Lancet​
4) Lancing Device​
5) Control Solution​
As per my understanding, the applicable regulation for the above product is - RESOLUTION - RDC NO. 36, OF AUGUST 26TH, 2015. But, i am not sure whether the inmetro is required or not since the product has/ require 3 volt lithium battery- please help me to understand Inmetro requirements clearly.

Questions

Q.1. Control Solution, does ANVISA classify this as a medical device?

Q.2. We don’t have any test report, whether Inmetro is required for the blood glucose monitoring device?


Thanks in advance,
 
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Marcelo

Inactive Registered Visitor
Hi, unless the blood glucose monitor is a medical electrical equipment (for example, the strip is linked to the the device for use and it touches the patient while connected to the device), it does not require Inmetro certification.

Anyway, there's a specific guidance note from ANVISA requiring compliance, between other things, to ISO 15197:2013 and they required that test reports are sent together with the submission - see INSTRUÇÃO NORMATIVA No 24, DE 17 DE MAIO DE 2018.
 

Mallappa

Involved In Discussions
Hi, unless the blood glucose monitor is a medical electrical equipment (for example, the strip is linked to the the device for use and it touches the patient while connected to the device), it does not require Inmetro certification.

Anyway, there's a specific guidance note from ANVISA requiring compliance, between other things, to ISO 15197:2013 and they required that test reports are sent together with the submission - see INSTRUÇÃO NORMATIVA No 24, DE 17 DE MAIO DE 2018.

Thank you Marcelo. I appreciate you help.
 
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