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Medical Device Approval in Brazil - Understanding INMETRO and ANVISA

MIXOLYDIAN

Starting to get Involved
#81
Marcelo: Do you know how I can find out what is the classification for a Hearing Aid (medical device) in Brazil? I checked ANVISA website but had no results.
Thanks.
 
A

Amy Wong

#83
Hello,

Does anyone know how long does it usually takes for the INMETRO Certification Process in Brazil, consider as a Class II Active Medical Device already have a valid IEC 60601-1 test and the IEC 60601-2-xx Particular?

Regarding the N 09 / 2013, for our device, the corresponding "IEC 60601-2-xx Particular" is not found on the list, does anyone has experience or recommendation to tackle this?

Many thanks for all of the information here! Always find it useful!

Thank you
 

Marcelo Antunes

Addicted to standards
Staff member
Admin
#84
Does anyone know how long does it usually takes for the INMETRO Certification Process in Brazil, consider as a Class II Active Medical Device already have a valid IEC 60601-1 test and the IEC 60601-2-xx Particular?
A rough estimate is something between 3-8 months, depending on some factors.

Regarding the N 09 / 2013, for our device, the corresponding "IEC 60601-2-xx Particular" is not found on the list, does anyone has experience or recommendation to tackle this?
IN 09/2013 has been replaced by IN 11/2014.
 

somashekar

Staff member
Super Moderator
#87
As I was looking through the MDSAP QMS manual along with the MDSAP Audit model, I find that the Audit model at several places draws your attention to Additional country-specific requirements., while the MDSAP QMS Manual does not state any such.
Ex:
>> Confirm that the manufacturer maintains a master list of the approved and effective documents [RDC ANVISA 16/2013: 3.1.5].
>> Verify that electronic records and documents have backups [RDC ANVISA 16/2013: 3.1.6].

Is from MDSAP Audit model, while this is not in the MDSAP QMS Manual ~~~
.
..
...
So how is the MDSAP QMS Manual serving the manufacturers to align with the requirements of the four participating regulators as it does not captures specific country requirements.
Should one then go back to RDC 16 / FDA 21 CFR 820 ... and others to not miss out specifics...
What then is the use of the MDSAP QMS Manual ... ??
 

Marcelo Antunes

Addicted to standards
Staff member
Admin
#88
The MDSAP QMS Manual is the QMS manual for the MDSAP program (for use by regulators), not for use of manufacturers applying the program.
 

somashekar

Staff member
Super Moderator
#89
The MDSAP QMS Manual is the QMS manual for the MDSAP program (for use by regulators), not for use of manufacturers applying the program.
The MDSAP Quality Management System (QMS) provides guidance to:
(1) Design and develop processes, products/outcomes, and services related to the MDSAP’s mission, and to critical management and administrative support services, and
(2) Continually improve and strengthen product/outcome and service quality.
This MDSAP Quality Management System Manual contains the required information to implement quality principles and practices throughout MDSAPs sites. The anticipated audience for this manual includes those in the public, regulated industry, counterpart agencies, and other MDSAP participants and members who wish to understand MDSAP QMS.
.... From the Foreword of the MDSAP QMS Manual...
 

Marcelo Antunes

Addicted to standards
Staff member
Admin
#90
The MDSAP Quality Management System (QMS) provides guidance to:
(1) Design and develop processes, products/outcomes, and services related to the MDSAP’s mission, and to critical management and administrative support services, and
(2) Continually improve and strengthen product/outcome and service quality.
This MDSAP Quality Management System Manual contains the required information to implement quality principles and practices throughout MDSAPs sites. The anticipated audience for this manual includes those in the public, regulated industry, counterpart agencies, and other MDSAP participants and members who wish to understand MDSAP QMS.
Well, that´s exactly what I said. It´s the MDSAP program QMS manual.
 
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