Regulatory Open Forum

We are a medical device company and have Class II products distributed in Brazil by our distributors.  There has been changes in the RDC's that are very confusing when looking them up on the website.  Please could someone post a list of the current standards/regulations for Brazil and which ones have been superseded.  The list will be very useful for our upcoming audit.  Also it would be greatly appreciated if there is a consultant specifically for Brazil whom may be able address this. We are well aware of ANVISA 665/2022 which is the most current but would also like to know the full name of the standards/regulations.  Many thanks

Hello,

There are several RDCs issued in the last years, the most relevant ones are the RDC 665/2022 (requirements for Brazilian GMP) and the RDC 751/2022 (requirements for notification and registration of medical devices). Then, there are many other RDC related to both products and companies, for example:

RDC 67/2009      Provisions regarding post-market surveillance.

RDC 551/2021    Provides for the mandatory execution and notification of field actions by health product registration holders in Brazil.

RDC 687/2022    Provides criteria for the issuance and renewal of Brazilian GMP.

RDC 431/2020    Requirements for registration holders to upload the Instructions for Use (IFU) for registered medical devices to ANVISA's electronic portal.

RDC 340/2020    Establishes Rules for Post-approval Modifications.

RDC 591/2021    Establishes a globally harmonized Unique Device Identification (UDI).

Among other RDCs that may be applicable depending on the type of products you commercialise.

Best regards,

Guillermo

We are a medical device company and have Class II products distributed in Brazil by our distributors.  There has been changes in the RDC's that are very confusing when looking them up on the website.  Please could someone post a list of the current standards/regulations for Brazil and which ones have been superseded.  The list will be very useful for our upcoming audit.  Also it would be greatly appreciated if there is a consultant specifically for Brazil whom may be able address this. We are well aware of ANVISA 665/2022 which is the most current but would also like to know the full name of the standards/regulations.  Many thanks

I noticed these are all ANVISA. How does INMETRO fit into the Brazilian system? Is there a similar list for INMETRO regulations?

Hello,

There are several RDCs issued in the last years, the most relevant ones are the RDC 665/2022 (requirements for Brazilian GMP) and the RDC 751/2022 (requirements for notification and registration of medical devices). Then, there are many other RDC related to both products and companies, for example:

RDC 67/2009      Provisions regarding post-market surveillance.

RDC 551/2021    Provides for the mandatory execution and notification of field actions by health product registration holders in Brazil.

RDC 687/2022    Provides criteria for the issuance and renewal of Brazilian GMP.

RDC 431/2020    Requirements for registration holders to upload the Instructions for Use (IFU) for registered medical devices to ANVISA's electronic portal.

RDC 340/2020    Establishes Rules for Post-approval Modifications.

RDC 591/2021    Establishes a globally harmonized Unique Device Identification (UDI).

Among other RDCs that may be applicable depending on the type of products you commercialise.

Best regards,

Guillermo

We are a medical device company and have Class II products distributed in Brazil by our distributors.  There has been changes in the RDC's that are very confusing when looking them up on the website.  Please could someone post a list of the current standards/regulations for Brazil and which ones have been superseded.  The list will be very useful for our upcoming audit.  Also it would be greatly appreciated if there is a consultant specifically for Brazil whom may be able address this. We are well aware of ANVISA 665/2022 which is the most current but would also like to know the full name of the standards/regulations.  Many thanks

We are a medical device company and have Class II products distributed in Brazil by our distributors.  There has been changes in the RDC's that are very confusing when looking them up on the website.  Please could someone post a list of the current standards/regulations for Brazil and which ones have been superseded.  The list will be very useful for our upcoming audit.  Also it would be greatly appreciated if there is a consultant specifically for Brazil whom may be able address this. We are well aware of ANVISA 665/2022 which is the most current but would also like to know the full name of the standards/regulations.  Many thanks

We are a medical device company and have Class II products distributed in Brazil by our distributors.  There has been changes in the RDC's that are very confusing when looking them up on the website.  Please could someone post a list of the current standards/regulations for Brazil and which ones have been superseded.  The list will be very useful for our upcoming audit.  Also it would be greatly appreciated if there is a consultant specifically for Brazil whom may be able address this. We are well aware of ANVISA 665/2022 which is the most current but would also like to know the full name of the standards/regulations.  Many thanks

Here is a list of some of the current standards and regulations for medical devices in Brazil:

- ANVISA Resolution RDC No. 185, 22 October 2001: Provides classification rules for medical devices and establishes registration requirements for medical products.
- ANVISA Resolution RDC No. 40, 26 August 2015: Defines the cadastro registration requirements for the sanitary control of medical products classified as Class I and II.
- ANVISA Resolution RDC No. 36, 26 August 2015: Provides classification rules for in vitro diagnostic products and establishes registration requirements for these products.
- ANVISA Resolution RDC No. 16, 28 March 2013: Establishes requirements for Good Manufacturing Practices (GMP) for medical devices and in vitro diagnostic devices.
- ANVISA Resolution RDC No. 183, 17 October 2017: Provides inspection programs and administrative procedures for granting Good Manufacturing Practices Certificate to manufacturers of medical devices located outside the Brazilian territory and Mercosur.
- ANVISA Resolution RDC No. 687, 13 May 2022: Establishes criteria for granting or renewing the Certification of Good Manufacturing Practices for Medical Devices.

This list is not exhaustive.

------------------------------
John Zachary
Orca1 DI
------------------------------

Original Message:
Sent: 07-Jun-2023 01:40
From: Anonymous Member
Subject: Standards / Regulations - Brazil

This message was posted by a user wishing to remain anonymous

We are a medical device company and have Class II products distributed in Brazil by our distributors.  There has been changes in the RDC's that are very confusing when looking them up on the website.  Please could someone post a list of the current standards/regulations for Brazil and which ones have been superseded.  The list will be very useful for our upcoming audit.  Also it would be greatly appreciated if there is a consultant specifically for Brazil whom may be able address this. We are well aware of ANVISA 665/2022 which is the most current but would also like to know the full name of the standards/regulations.  Many thanks

Here is a list of some of the current standards and regulations for medical devices in Brazil:

- ANVISA Resolution RDC No. 185, 22 October 2001: Provides classification rules for medical devices and establishes registration requirements for medical products.
- ANVISA Resolution RDC No. 40, 26 August 2015: Defines the cadastro registration requirements for the sanitary control of medical products classified as Class I and II.
- ANVISA Resolution RDC No. 36, 26 August 2015: Provides classification rules for in vitro diagnostic products and establishes registration requirements for these products.
- ANVISA Resolution RDC No. 16, 28 March 2013: Establishes requirements for Good Manufacturing Practices (GMP) for medical devices and in vitro diagnostic devices.
- ANVISA Resolution RDC No. 183, 17 October 2017: Provides inspection programs and administrative procedures for granting Good Manufacturing Practices Certificate to manufacturers of medical devices located outside the Brazilian territory and Mercosur.
- ANVISA Resolution RDC No. 687, 13 May 2022: Establishes criteria for granting or renewing the Certification of Good Manufacturing Practices for Medical Devices.

This list is not exhaustive.

------------------------------
John Zachary
Orca1 DI

Original Message:
Sent: 07-Jun-2023 01:40
From: Anonymous Member
Subject: Standards / Regulations - Brazil

This message was posted by a user wishing to remain anonymous

We are a medical device company and have Class II products distributed in Brazil by our distributors.  There has been changes in the RDC's that are very confusing when looking them up on the website.  Please could someone post a list of the current standards/regulations for Brazil and which ones have been superseded.  The list will be very useful for our upcoming audit.  Also it would be greatly appreciated if there is a consultant specifically for Brazil whom may be able address this. We are well aware of ANVISA 665/2022 which is the most current but would also like to know the full name of the standards/regulations.  Many thanks

We are a medical device company and have Class II products distributed in Brazil by our distributors.  There has been changes in the RDC's that are very confusing when looking them up on the website.  Please could someone post a list of the current standards/regulations for Brazil and which ones have been superseded.  The list will be very useful for our upcoming audit.  Also it would be greatly appreciated if there is a consultant specifically for Brazil whom may be able address this. We are well aware of ANVISA 665/2022 which is the most current but would also like to know the full name of the standards/regulations.  Many thanks