Do you know the benefits of Passarini Group Hosting Service?

We will show you some triggers that can help you be more assertive in your business.

But what is Hosting Service anyway?

It is the hosting service for the registration of an imported product, where the holder is the Regulatory responsible for the product in Brazil.

And what are the advantages of using this hosting service?

* Have the entire process in your hands;

* Do not depend on your distributors’ commercial policies;

* Reduce the cost of your operation in Brazil, Hosting costs on average less than 4% of a local operation;

* Gain peace of mind in your project through our regulatory intelligence at your disposal on a daily basis;

* Just worry about your sales, don’t let the regulatory make you lose sleep;

* Hosting Service brings more security to your operation, as it eliminates the risk of loosing the registration obtained and the distribution;

* Gain speed, Hosting reduces on average 50% the time of registration;

* Host your registrations in a real One Stop Shop company, which will be able to meet all your demands.

What do you think?

There are many advantages that can help you, do you agree?

We are available to discuss new projects, send your questions by email: contato@passarini.com.br.

Passarini Group

Published: 07/06/2022

ANVISA – RDC No. 687 provides the criteria for granting or renewing the Certification of Good Manufacturing Practices for Medical Devices

Published on May 13th: RDC No. 687 provides the criteria for granting or renewing the Certification of Good Manufacturing Practices for Medical Devices.

The new legislation will get into force on June 1st, 2022. The new RDC 687/2022 revoques RDC 183/2017.

• Certification continues to be mandatory for manufacturers of class III and IV medical devices that produces final products on their behalf or for another company;
• The scope of the new RDC applies now for the activity of sterile barrier’s packing system for products declared as sterile. This is now considered a requirement for Certification of Good Manufacturing Practices (Brazil). It will also be required for IVD manufacturing sites that perform the steps of impregnation, lamination or cutting of immunochromatography strips;
• The structure of the standard were changed (chapters, articles and order);
• New definitions have been added and the list of documents for the petition has been changed as well;
• A period of 180 days was established for companies that need to make the necessary adequation and protocols.

NOTE: The deadline for renewal remains as established in RDC 497/2021

Link to access RDC 687/2022 in english, click here.

For more information and explanations about it, send us an e-mail: contato@passarini.com.br

Passarini Group

Published: 05/31/2022

ANVISA – Solicita System

For submission of documents for petitioning processes at the National Health Surveillance Agency – ANVISA, there are currently two systems: ELECTRONIC PETITION and SOLICITA SYSTEM.

The Solicita System was developed internally by ANVISA to make the demands of users to the Agency’s services fully digital. Solicita was implemented in July/2019 with the aim of improving efficiency on process analysis and to enable access to Solicita through modern browsers and it was initially developed for the sectors that still received paper processes at the time when was released: Food; Sanitary Inspection and Surveillance; Technovigilance; Ports, Airports, Borders and Customs Areas (in express shipment); and Toxicology.

The Solicita System is essential to ANVISA’s digital transformation project, being aligned with the Federal Government’s Digital Government Strategy, which aims to reduce the need for citizens to travel to the processes protocol counters and eliminate the entry of paper in ANVISA.

During these almost 3 years in which the Solicita System has been available for petitioning processes at ANVISA, several functionalities have been incorporated into Solicita, among them: Access to Company Mailbox; Tools for Technical Demand Fulfillment; Petitioning for Company Operation Authorization (AFE) and Special Authorization (AE); Transfer of Ownership of Medicines and Health Products; Consultation of reasons for rejection and non-consent of medical devices.

To consult the List of subjects migrated to the Solicita System, access the link: https://www9.anvisa.gov.br/peticionamento/sat/global/listaAssuntosSolicita.asp

To access the Solitica System, access the link: https://sso.anvisa.gov.br/sso/internet/login?service=https%3A%2F%2Fsolicita.anvisa.gov.br%2Fsolicita%2F

For more information about the Solicita and to view the Solicita Manual, access the link: https://www.gov.br/anvisa/pt-br/sistemas/peticionamento

For more information and explanations about it, send us an e-mail: contato@passarini.com.br

Passarini Group

Published: 04/26/2022

ANVISA – Published on March 30th: RDC No. 665, which provides Good Manufacturing Practices for Medical Products and In Vitro Diagnostic Products.

The new RDC will come into force on May 2nd, 2022. The new RDC 665/2022 revoked RDC 16/2013 and incorporated IN 8 of 2013.

ANVISA published in the Official Gazette, on March 30, 2022, the COLLEGIATE BOARD RESOLUTION – RDC No. 665, which provides Good Manufacturing Practices for Medical Products and In Vitro Diagnostic Products. See more details below:

1. The scope of the new RDC is now expanded and mentions manufacturers, distributors, storers and importers of medical devices and in vitro diagnostic products that are commercialized in Brazil;
2. There were changes in the structure of the standard (chapters, articles) as well as minor text adjustments;
3. The management representative remains mandatory, being more explicit;
4. It is now an explicit requirement to establish the responsibility, authority and interrelationship of all personnel who manage, perform and verify quality-related work;
5. RDC 665 details the Risk Management requirements, however there is no difference to what is already expected to be implemented;
6. Continuous Risk Management Process, RDC 665 clarifies that the points of continuous analysis of the GER, which is already established by ISO14971:2019
7. The design requirements remain, they were just reorganized;
8. Evidence that suppliers have received specifications for materials and services is now required for each purchase.
9. Article 70 mentions that all personnel who are in contact with the product or its environment must be clean, healthy and properly dressed. This also includes people outside the organization as service providers.
10. Inspection of labels and instructions for use must be documented in the product’s historical record. This requirement is now applicable to importers.
11. It was made clear that all documents must be available whenever requested by health surveillance agencies.

• Stay Tuned: authorization letters that mentioned RDC 16/2013 must be changed to the new RDC665/2022
• References, including chapters and structures, to RDC 16/2013 in quality documents must be changed as well.

Link to access RDC 665/2022 in english, click here.

For more information and explanations about it, send us an e-mail: contato@passarini.com.br

Passarini Group

Published: 04/14/2022

ANVISA – COLLEGIATE BOARD RESOLUTION – RDC Nº 657, OF MARCH 24, 2022: Provides for the regularization of software as a medical device (Software as a Medical Device – SaMD)

ANVISA published in the Official Gazette, on March 30, 2022, the COLLEGIATE BOARD RESOLUTION – RDC No. 657, OF MARCH 24, 2022, which provides for the regularization of software as a medical device (Software as a Medical Device – SaMD), a milestone for the software market in Brazil, as it is ANVISA’s first RDC that deals exclusively with this product category.

Effective from July 1, 2022, RDC 657/2022 establishes the requirements for the regularization of software as a medical device (Software as a Medical Device – SaMD), defined as Software that meets the definition of a medical device, may be in vitro diagnostics (IVD) or not, being intended for one or more medical indications, and which accomplish those purposes without being part of medical device hardware. Includes mobile applications and software for in vitro purposes, if their indications are included in the general definition of medical devices. This definition includes, among others, software licensed by subscription and centrally hosted (Software as a Service), which meets the definition of medical devices.

According to RDC 657/2022, software with medical applications that are considered accessories for the exclusive use of medical devices and software with embedded medical applications must be regularized together with the medical devices under the associated health surveillance regime. In addition, SaMD must be framed in the rules and classes according to the Collegiate Board Resolution – RDC No. 185, of October 22, 2001, or subsequent regulations.

For SaMD for in vitro, notwithstanding the risk classification of SaMD for in vitro, its regularization must follow the other rules in accordance with the Resolution of the Collegiate Board of Directors – RDC No. 185, of October 22, 2001, or subsequent regulations.

The SaMD developed internally (in house) by the health service and for the exclusive use of the health service, head office or branches, which fall into risk classes I and II, will not be subject to regularization at Anvisa, as long as they do not interfere with the functioning of medical devices subject to regularization, being prohibited their commercialization or donation of the SaMD developed internally, without proper regularization at Anvisa.

Finally, the regularization of a SaMD must follow the general provisions of medical devices, in particular the Collegiate Board Resolution – RDC nº 185, of October 22, 2001, and the Collegiate Board Resolution – RDC nº 40, of August 2015, including its updates, and the manufacturer is not allowed to commercialize, in the form of licensing or equivalent, or to make the SaMD or its updates available to new users with expired or canceled regularization.

Link to access RDC 657/2022 in portuguese, click here.

For more information and explanations about it, send us an e-mail: contato@passarini.com.br

Passarini Group

Published: 04/05/2022

UDI for Brazil – ANVISA

Published on December 29th, 2021, and effective as of January 10, 2022, ANVISA informed that it will require the UDI (Unique Device Identifier) in the labeling of registered products and marketed in Brazil.

The UDI is composed of the UDI-DI (DI = Device Identifier) and the UDI-PI (PI = Production Identifier).

UDI-DI: Unique numeric or alphanumeric code, specific to a device model, which is also used as an “access key” to information stored in a UDI database.

UDI-PI: Numerical or alphanumeric code that identifies the device’s production unit. The different UDI-PI types include one or more of the following information: serial number, batch number, version (for Software as a Medical Device – SaMD), date of manufacture, and expiration date.

The measure is part of a worldwide trend to improve the traceability and safety of our medical devices.

The implementation deadlines are already defined, based on the risk class of each product*. Please see below:

• 2.5 years for risk class IV medical devices.
• 3 years for risk class III medical devices.
• 4 years for risk class II medical devices.
• 6 years for risk class I medical devices.

*Some products are treated exceptionally and may have a different deadline/condition for implementation.

The UDI must be generated by an issuing agency.

Passarini can support you in understanding and implementing the UDI in your labeling.

For more information and explanations about it, send us an e-mail: contato@passarini.com.br

Passarini Group

Published: 01/26/2022

We are ONE STOP SHOP!

A term used very much by companies that can concentrate all the solutions sought by their customers in one place, without outsourcing or the need to involve other companies in the delivery of its services.

We are the only regulatory company in Brazil to offer registration, distribution and import services in Brazil without outsourcing.

All services in one place! Check it out here.

Therefore, from now on you will see our commemorative stamp in our publications.

Check below:

ATTENTION: Passarini Group is the owner of all the companies within the group, none of them are outsourced, that is a TRUE ONE STOP SHOP!

We are looking forward to getting to know your project.

How can we help you?

Fly higher with Passarini Group!!

Published in: 8/13/2021

Resolution of the Directive Board (RDC) 432, November 4th, 2020 – ANVISA

ANVISA has published the Resolution of the Directive Board – RDC nº432 to establish the obligation of describing the composition of personal hygiene products, cosmetics, and perfumes in the Portuguese language on the labeling.

The Resolution will be in force from November 5th, 2021.

– It will be mandatory to describe in the labeling of personal hygiene products, cosmetics, and perfumes their respective composition in Portuguese, without any prejudice of the other requirements predicted in the legislation in force.

– The International Nomenclature of Cosmetic Ingredient (INCI) remains mandatory in the labels of personal hygiene products, cosmetics, and perfumes.

– The chemical composition in the Portuguese language must be presented on the original label of the product, on a complementary label, as long it’s assured the integrity of the colors and the material on which the label is manufactured, in a way to prevent the partial or total removal of the label ( it’s mandatory to use the updated Brazilian Common Denomination – DCB – or any other reference pointed out by ANVISA).

When there’s not a description of the substance in the Brazilian Common Denomination (DCB) – or other reference pointed out by ANVISA, the manufacturer is obligated to translate the name of the substance to the International Nomenclature of Cosmetic Ingredient (INCI) and to recognize the lack of translation to the Portuguese language.

– The products manufactured before the enforcement of this Resolution can be commercialized until their respective dates of expiration.

– It’s not necessary to submit a petition of Alteration of Labels of the registered products when they are intended exclusively for the fulfillment of this Resolution.

– The failure of complying with the requirements of this Resolution is a sanitary infraction submitted to the penalties predicted in Law nº 6.437, of August 20th, 1977, without losses of civil or penal sanctions applicable.

Access the full content of the Resolution in the link below:

RDC Nº 432

For more information and explanations about it, send us an e-mail: contato@passarini.com.br

Passarini Regulatory Affairs

Published: 11/11/2020

Resolution of the Directive Board (RDC) 431, October 31st, 2020 – ANVISA

ANVISA has published the Resolution of the Directive Board RDC 431/2020 where establishes the loading of instruction for use on the ANVISA website. The loading is MANDATORY and the holder of the product is responsible for imputing and updating the instructions for use. This procedure applies to medical devices of all risk classifications.

The RDC 431/2020 becomes in force from November 1st, 2020. The instructions for use of products regularized until this day must be uploaded to ANVISA’s website within 12 months. The instructions for use for products approved after November 1st  must be uploaded within 30 days after the favorable conclusion of the petition or after implementation of the non-reportable change that implies a change in the instructions for use.

The instructions for use uploaded on ANVISA’s website will be available for consultation in the ANVISA’s database. The content of the instructions for use must be under the legislation in force and must be consistent with the regularized product.

In cases of regularized medical devices without a User Manual or similar material, the company must load the label model in the ANVISA’s website, in the instruction for use field.

The lack of uploading of the instruction for use may generate an extra evaluation of documents and taxes by ANVISA at any time. ANVISA also may withdraw the instructions for use of the website, restore an earlier version of the document, or determine other penalties provided for in Law 6.437/1977.

Access the full content of the Resolution in the link below:

RDC Nº 431

For more information and explanations about it, send us an e-mail: contato@passarini.com.br

Passarini Regulatory Affairs

 

 

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Published: 10/26/2020