LATEST NEWS

Class I Medical Devices Notification

Date: 03/12/2019

On March 1st, 2019, ANVISA published RDC 270 / 2019 in the Brazilian Official Gazette. The new legislation deals with the migration of the cadastro route to the notification route for Class I medical devices (materials, equipment and IVD products). RDC 270/2019 amends RDCs 36 and 40/2015 and shall enter into force as of May 2, 2019.

 

To date, the regularization of Class I medical devices has taken place through the cadastro process. Under the new Resolution, the lowest risk products will be regularized through notification – a simplified system in which there will be no prior technical analysis of the petitions. The publication of the notification is expected within 30 days following the notification’s application and the payment of the ANVISA fee; that’s regardless of any documentary analysis by ANVISA. Only after the granting of the notification number can the product be industrialized or commercialized.

 

Here are some important topics featured in RDC 270/2019:
– The documentation required for the initial request and alteration of Class I medical devices remains the same, only with the change from the cadastro form to the notification form.

– The labels and instructions for use of notified products must comply with the requirements established in RDC 185/2001.- The notified products are exempt from revalidation.

– ANVISA may cancel product notification in such cases when it is proven that the product or the manufacturing process poses a risk to the health of the consumer, the patient, the operator or third parties involved; it’s also the case when information is deemed insufficient or there is an error in the sanitary framework of the notified products.

– The Technical Product Dossier remains mandatory for notified products.
– The notifications, their alterations and other actions will be published exclusively in the ANVISA website, in the section of consultation to regularized products.

– There will be no prior technical analysis of the notification requests; however, ANVISA reserves the right to make documentary evaluations of the notification processes at any time.

– The new legislation applies to the processes awaiting the first manifestation upon its entry into force.
– Class I devices already registered in ANVISA will have their cadastrosautomatically converted into notifications, maintaining the same registration number.

MORE NEWS

ANVISA publishes RDC n °183-2017 that changes procedures for concession of Certificate of Good Manufacturing
11/15/2017
On October 19th 2017, ANVISA published the RDC nº 183 which complements the provisions of RDC nº 39/2013. The new legislation amends the list of documents required for GMP application protocol, making it mandatory to submit further information on the latest inspections and audits carried out at the manufacturing plant subject to certification. [...]
See more >
ANVISA Extends the Validity of Medical Device Registry to Ten Years
01/31/2018
On January 23 2018, ANVISA issued Resolution RDC 211 and RDC 212/2018, which deal with the validity period of medical device registry, as well as with the procedures related to the renewal of product registration. According to the new legislation, the registries of medical devices and IVDs (risk classes III and IV) will have a...
See more >
Medica Fair
10/30/2018
Domo Salute will attend Medica Fair 2018 in Düsseldorf – Alemanha from November 12th to 15th, 2018. Medica is the leading international trade fair for medical sector and it is a very attractive event: more than 5100 exhibitors from 66 nations. It will be a pleasure to meet you there if you will attend the...
See more >
PUBLIC CONSULTATION ANVISA- single use and reusable medical devices
01/16/2019
Some medical devices may be used more than once and be reprocessed safely. This practice gives them a longer product life and use, as long as they provide effectiveness and functionality. Medical devices that may be processed are those that allow repeated cleaning, disinfection or sterilization and that can be reused, given they comply with... [...]
See more >
Medical devices now enjoy the use of electronic petition
01/23/2019
ANVISA opened on Monday (January 21thst), in the Electronic Petitioning System, the Electronic Compliance of Requirements for Medical Devices. According to the Agency, of February 25, the subject codes of secondary petitions (changes, revalidations, additions, cancellations, rectifications, among others) will also be available for electronic [...]
See more >
Welcome Saúde 2019- the event that presented the political and economic perspectives for the health
01/31/2019
On January 29th, Domo Salute attended the event “Welcome Saúde 2019 ”(link event) organized by Media Group to welcome the health sector this year. The event discussed the political and economic perspectives for the sector and brought experts and authorities from different links in the health chain. A survey conducted by Media Group noted [...]
See more >
Brazil has a new Minister of Health: Luiz Henrique Mandetta
02/06/2019
  Jair Bolsonaro, Brazil’s new president, began his four-year mandate on January 1st. One of the attributions of the new Brazilian leader is the structuring of his team and his ministers are the most important people in this group. The new Health Minister, Luiz Henrique Mandeta, is a doctor from Campo Grande city, Mato Grosso...
See more >
Arab Health 2019 in Dubai and DOMO Salute will be there
02/14/2019
Link para o vídeo: https://youtu.be/PicwqlhAELI Arab Health is the largest healthcare event in the MENA (Middle East and North Africa) region. More than 4,150 exhibitors from 160 countries and 84,500 visitors expected to attend Arab Health 2019 taking place from 28 – 31 January in Dubai, UAE and DOMO SALUTE will be part of it...
See more >
Class I Medical Devices Notification
03/12/2019
On March 1st, 2019, ANVISA published RDC 270 / 2019 in the Brazilian Official Gazette. The new legislation deals with the migration of the cadastro route to the notification route for Class I medical devices (materials, equipment and IVD products). RDC 270/2019 amends RDCs 36 and 40/2015 and shall enter into force as of May...
See more >
How were SAHE (South America Health Exhibition) and Expert Directory Event 2019
03/25/2019
DOMO Salute attended two events this month: SAHE (South America Health Exhibition) and Expert Directory Event 2019, promoted by Swiss Business Hub Brasil. SAHE, which took place from March 12th to March 14th, held more than twenty forums, gathering over 400 speakers throughout the three-day schedule, thus offering around 400 hours of content [...]
See more >
What about INMETRO
03/28/2019
A significant number of manufacturers that look for our regulatory services are not just searching for ANVISA registration services, their doubts are related to INMETRO certification processes and their requirements, which many times are not thoroughly discussed when planning a regulatory strategy for medical devices’ registration in Brazil. [...]
See more >
Domo Salute at the 26th edition of Hospitalar Trade Fair
06/05/2019
For the third consecutive year, Domo Salute has participated in the most relevant Latin American showcase in the health sector: Hospitalar Trade Fair. At Rio Grande do Sul’s collective stand, which was organized by Sebrae RS, Health Technology Cluster and the State Government, companies had the opportunity to advertise their products and [...]
See more >
BRAZIL’s INMETRO proposing new model
07/19/2019
INMETRO has issued a public consultation regarding the proposal for what they are calling a “New regulatory model for INMETRO”. The main goal, according to INMETRO’s director Gustavo Kuster, is to make Brazilian market safer for society and citizens and to create a less bureaucratic and more simple system. The action is a part of...
See more >
ANVISA`s Regulatory guillotine
07/30/2019
In 2014, ANVISA created a management model for its regulatory stock based on the organization of thecurrent rules, monitoring their effectiveness and generating inputs for their review. The goal was, and still is, to make the stock more efficient, rational, clear and understandable.   According to civil servant Raianne Liberal [...]
See more >
ANVISA’s performance report: An analysis on medical device and IVD registration
08/23/2019
ANVISA has published the second trimestral GGTPS (Medical Device Technology General Management) performance report. The report presents data, results and metrics concerning the first two trimesters of 2019. The first report, published ion April, can be found on ANVISA’s website. According to Leandro Rodrigues Pereira, General Manager of the [...]
See more >
ANVISA’s special report: 2018 results
09/05/2019
ANVISA publishes 2018 management results Brazilian medical device market regulator ANVISA recently published the annual Management Report concerning 2018’s results. According to Willian Dib, ANVISA’s CEO, presenting the annual report to the society reaffirms the Agency’s commitment and transparency. DOMO’s Team has evaluated the report and [...]
See more >
Contacting Brazilian Regulatory Agencies – ANVISA, INMETRO e ANATEL
09/20/2019
ANVISA recently opened a new communication channel and our team prepared an update on all the available resources for contacting Brazilian key Regulatory Agencies, concerning medical devices. Knowing how to reach out to the agencies can help if you intend on entering the Brazilian Market.   ANVISA   Central de Atendimento / Call [...]
See more >
ANVISA’s Digital Plan
10/17/2019
  ANVISA, the Ministry of Economy and the Presidency approved, on Wednesday (9/10), the Agency’s Digital Plan. As a part of the strategy to implement the Executive Power’s Digital Governance Policy, the program wishes to transform 120 ANVISA services to digital by the end of 2020. Throughout 2019 we have had significant [...]
See more >
Brazilian Regulatory System – News Roundup
10/25/2019
Our team has compiled a few important news from the past days concerning medical device’s regulation and the Brazilian regulatory system:   Field safety correction action information is now submitted to ANVISA by electronic system    Since the 22th of July manufacturers must submit field safety correction action information via [...]
See more >
Meet our team at MEDICA 2019
10/29/2019
We are proud to participate once again the world’s largest event for the medical sector – MEDICA 2019 – from November 18th to November 21st in Düsseldorf, Germany. We’ll be at MEDICA 2019 to talk about how we’re helping medical device companies bring to market new products to Brazil, and discuss the key areas of...
See more >
BRAZIL’s INMETRO proposing new model
11/10/2019
INMETRO has issued a public consultation regarding the proposal for what they are calling a “New regulatory model for INMETRO”. The main goal, according to INMETRO’s director Gustavo Kuster, is to make Brazilian market safer for society and citizens and to create a less bureaucratic and more simple system. The action is a part of...
See more >
Brazilian Regulatory System – News Roundup
11/10/2019
Our team has compiled a few important news from the past days concerning medical device’s regulation and the Brazilian regulatory system:   ANATEL – New regulation for Conformity Assessment and Homologation of Telecommunication Products   ANATEL approved on October 17th, the new Regulations for Conformity Assessment and Homologation [...]
See more >
ANVISA’s Public Consultation nº 730/2019 and 734/2019
12/06/2019
  Updates regarding Definitions, Classification, Registration Pathways, Labeling and Instructions for Use requirements for Medical Devices and IVD Medical Devices   ANVISA has opened in last October the Public Consultation 730/2019 to discuss with the community updating RDC 185/2001, the standard that drives medical device [...]
See more >
Normative Instruction 49/2019 updates list of Technical Standards for medical device compliance certification
01/03/2020
  In order to approve and update the list of Technical Standards equipment under Health Surveillance must comply with, ANVISA published last November the Normative Instruction number 49, which came into effect immediately after the publication (22nd November 2019). It is important to highlight that Normative Instructions No. 4  (September [...]
See more >
ANVISA publishes IMDRF Guides for medical devices’ Clinical Evaluation
01/16/2020
ANVISA published last December three Guides from the International Medical Device Regulators Forum (IMDRF), related to the scenario of clinical evaluation of medical devices in Brazil. The Guides express ANVISA’s understanding of best practices regarding procedures, routines and methods deemed appropriate to meet technical or [...]
See more >