Establishment registration and device listing for manufacturers and initial importers of medical devices low 4. For market entry, organizations should obtain market authorizations and product registrations from anvisa. Anvisa regulatory guidelines list of high impact articles. This resolution will be applicable to all clinical trials with medical devices for registration in brazil. Anvisa may suspend or cancel registration of medical devices in certain cases. Jun 10, 2015 the adequacy of the new packages will be checked by anvisa during the process of authorization renewal and postregistration analysis. The brazilian health surveillance agency anvisa south south cooperation. The company must be in good standing and fully authorized by anvisa. Anvisa registration must be requested through a brazilian company brazilian registration holder. The approval of medical devices in russia is divided into two steps. The registration is done through cadastro or registro processes basing on the device classification class i, ii, iii and iv which also decides the extent of scrutiny involved for approval.
The anvisa registration process takes 6 to 12 months before your. Tuv sud can offer you a service to demonstrate compliance for your medical devices within the brazilian market. Anvisa medical device registration in brazil domo salute. Anvisa requires that all devices must complete a device registration process. Device marketing authorization and facility registration section 2 confirm the organization has received appropriate device marketing. Brazilian fmp rdc anvisa 1620japan mhlw ministerial ordinance no. Overview brazil is one of the biggest countries in south america and latin america. Anvisa registration process all medical devices imported into or distributed within brazil must first be registered with the agencia nacional.
On the other hand, some medical devices require registration, even if classified as class i or class ii, because of the potential risk involved, as indicated in resolution rdc anvisa 185 of october 22, 1999, and other complementary regulations also used in this process. Article 4 the provisions of this resolution shall not exempt the manufacturers and importers of the obligation to ensure that medical devices marketed by them, regardless of their risk class, have been produced and distributed in compliance with the the applicable standards of good manufacturing practices issued by anvisa. Brazil has four classes of devices with ascending risk, and three registration pathways. In brazil, the institution that oversees medical device regulations is the brazilian national health surveillance agency anvisa the beginning of the medical device registration process requires the classification of the device according. You also need to know about approval timelines so you can plan your market entry accordingly. Anvisa medical device registration and approval in brazil. About the author luiz levy is the director of qara for emergos office in brasilia. Brazil s medical device market offers significant growth potential for foreign manufacturers, but the countrys device approval process is challenging. May 05, 2011 appoint a company that holds a company working allowance permit from anvisa as your brazil registration holder brh. Inmetro certification for medical devices sold in brazil.
Gmp inspections of the manufacturing sites in brazil or abroad conducted by brazilian auditors take place prior to filing for product registration with anvisa. Dec 12, 2018 brazil, the largest country in south america, has become the second largest pharmaceutical market in the emerging world. Paho issued anvisa with the high level qualification. Brazil, the largest country in south america, has become the second largest pharmaceutical market in the emerging world.
It is coming from the collaboration of some countries in the world who decided to work together to implement a unique audit program. Nonbrazilian manufacturers need a local brazilian registration holder brh based in brazil to submit technical files to anvisa. Brazil medical device registration anvisa approval. Medical devices in brazil are regulated by the national health surveillance agency anvisa and by the national institute of metrology standardization and industrial quality inmetro, both issuing mandatory regulations to which medical devices companies must comply as well as voluntary product standards. Informational medical device registration process in. General overview of the brazilian regulatory framework 3.
This thesis examines the regulatory requirements for medical devices in argentina. Also, for some classes of products, manufacturers might have to be certified by anvisa, a process which might include inspections at the place of origin. Jul 06, 2015 brazil is one of the fastest growing device markets in the world. The brazilian health surveillance agency anvisa south south. Pdf medical device regulatory requirements for brazil.
Mdsap is a program that looks during one audit at all 5 countries regulations including the iso 485. Anvisa requires premarket approvals only for the categories of products that are considered to be of greatest health risk. One of the major issues for companies developing and producing medical devices is to be updated on the regulatory requirements and implement them in the process. Gain market access in brazil with anvisa approval bsi. Nov 06, 20 just a general update on gmp and registration cp 50 has been published to revise rdc 25. Brazil medical device registration and approval chart emergo. Anvisas role it to promote the protection of the populations health by executing sanitary control of the production, marketing and use of products and services subject to health regulation, including related environments, processes, ingredients and technologies, as well as the control in ports, airports and borders.
All medical devices in brazil are regulated by the brazilian health surveillance agency anvisa. On march 3, 2020, anvisa published a new regulation rdc 3402020 that classifies the changes made to approved medical devices in brazil, into three categories, based on the level of risk they can present to their users. Registration process for medical devices in brazil youtube. Medical device manufacturers participation in the medical. Anvisa has established essential requirements for compliance similar to those developed in the european union, and provides two major pathways to device approval. Lower risk class i and ii devices will follow the cadastro registration route, which includes a simplified application. An overview of important medical device regulations in brazil. The first step in the brazilian regulatory process is to determine the correct classification of your medical device. Brazil anvisa regulatory approval process for medical devices. The requirement for medical device registration andor listing with anvisa. Anvisa s role it to promote the protection of the populations health by executing sanitary control of the production, marketing and use of products and services subject to health regulation, including related environments, processes, ingredients and technologies, as well as the control in ports, airports and borders. For medical device registration at anvisa, an audit report based on mdsap would also be accepted. All anvisa medical device vigilance and safety requirements are applicable to custommade devices. Its now among the top 10 markets and spends as much on healthcare as the uk.
Some of the small countries nearby brazil are following the rules according to anvisa. Download the chart in pdf, or read below for the explanation of the process. Brazils base regulations and medical device classification schemes are similar to those found in the european mdd 9342eec. Cadastro is simpler and faster, but both cadastro and registro require formal registration and approval from anvisa. The cadastro registration is for lower risk devices, has a simplified application, and typically takes less time than registro. Our guide for how to register medical devices in brazil.
Brazil brazils anvisa approves formal regulations for. With more than 10 years of experience in medical device regulatory and quality affairs, his expertise includes anvisa registration submissions and quality management system implementation and audits to rdc 16, iso 485, iso 9001, fda qsr, and other qms standards. Further, all the medical device manufacturers need to comply with brazilian good manufacturing process bgmp which is in lines with iso 485. Companies must provide traceability labels as part of regulatory compliance.
A guide for importing medical equipment into brazil 1. This is a simple process that applies to medical devices classified according to the first paragraph of article 25 of law no. The monitoring authority in brazil known as anvisa is known for its work and functions with their set of requirements for gmp inspections. Its important to understand the process upfront to avoid delays down the road. Your brh maintains control of your device registration and brazil good manufacturing practice bgmp certification, if applicable.
Anvisa adopted mdsap anvisa may expand certifications of laboratories authorized to. Pdf medical devices registration by anvisa agencia. Anvisa recently introduced a new requirement for medical device manufacturers who will be conducting clinical investigations. There are two routes to anvisa approval, cadastre and registration. Defines all medical product cadastro registration requirements. Some categories of products subject to health regulation are exempt from the need of obtaining premarket approvals, because they represent a lower health risk, as established in article 41 of law 9.
In this white paper, well answer your biggest questions about anvisa medical device registration. Download the chart in pdf, or read below for the explanation of the. The text proposes that the exemption list for cadastre be revoked meaning that all class i and ii devices will only be cadastre, and permits the beginning of the registration process with the inspection protocol which was already being done. Anvisa changes for lowrisk medical devices brazilian market. This evaluation will impact the process of drugs prequalification of paho, as well as it will help guide regional cooperation in the field of health surveillance. Anvisa is a part of nsss national system of sanitary surveillance nsss is an organization of brazil whose responsibility is to keep a watch over certain professional activities to put a stop to charlatanism to inspect ships, cemeteries and places where food was on sale to the public. This will strength the relation among anvisa and the main.
Anvisa has also presented its official application to pics. In english, it means national health surveillance agency or sometimes it is written as brazilian health surveillance agency. Overview with a booming economy and with both the domestic and multinational companies equally fulfilling the need of pharmaceutical and medical technology in the country, brazil boasts a good fortune for foreign medicine and medical devices investors. Validity timeframes for some devices may be increased to up to 10 years depending on product characteristics and risks. The result of this audit can be used by all the countries that are part of this partnership. Anvisa registration for custommade medical devices.
Anvisa primarily aims at protecting and promoting public health, exercising health surveillance of products and services that include processes, ingredients and technologies that may pose any health risks. The medical device single audit program mdsap audit process was designed and developed to ensure a single audit will provide efficient yet thorough coverage of the requirements of medical. Certificate of medical devices of risk classes iii and. Informational medical device registration process in brazil. Electro medical devices iec 60601 is the international standard for safety of electro medical devices.
Class ii medical device manufacturers must follow the cadastro registration process with anvisa. Informational medical device registration process in brazil anvisa. Listing is the first step in the registration process of all medical devices. Medical device registration process in brazil anvisa marceloall, is there an rdc that aligns with section 8. Medical devices are becoming more important in the health care sector. It spends hugely on healthcare boosting the medical devices locally. A guide for importing medical equipment into brazil. Dec 11, 2018 mdsap stands for medical device single audit program. You may need to comply with mapa ministry of agriculture requirements, but i would not know which since this is not my area of expertise. Exporting to brazil exporting products regulated by anvisa to brazil might include the need for specific premarket authorizations issued by regulatory bodies in brazil. Medical device registration in brazil, anvisa, brazil. The joint board of directors of the brazilian health surveillance agency anvisa, in exercise of the powers conferred by items iii and iv of art. The overall objective of the medical device single audit program is to develop, manage, and oversee a single audit program that will allow a single regulatory audit of a medical device manufacturer conducted by an mdsap recognized auditing organization certification body to satisfy the needs of multiple regulatory jurisdictions. Internationally, anvisa has been moving towards regulatory convergence by implementing new registration procedures based on best practices from the international medical device regulator forum imdrf.
Drug, medical device registration, cosmetics, brazil, anvisa. Anvisa requires certain medical devices to be certified by the national. Medical device registration process in brazil emergo. Jun 25, 2015 brazil s medical device market offers significant growth potential for foreign manufacturers, but the countrys device approval process is challenging. Brazil medical device registration process chapter 2. Medical device single audit program mdsap initiative. Provide letter of authorization to your brh, who will submit your registration application to anvisa. The brazilian anvisa medical device approval process explained.
Electro medical devices entering brazil require a mandatory inmetro iec 60601 product certification, this must be. Iii manufacturing site of software as a medical device samd. Medical device registration and approval in brazil general countryspecific regulatory information is provided on this page for medical device registration and approval in brazil. Medical device single audit program mdsap introduction.
Anvisa may use mdsap audits in lieu of a premarket inspection by anvisa to grant anvisas gmp certificate to manufacturers intending to put medical devices of class iii or iv on the brazilian market. Medical device registration process in brazil anvisa part. Brazil is the largest medical device market in latin america, and it has a wellestablished but rather complex regulatory system. For class i medical devices, anvisa has established a marketing path based on product notification, a simple communication, in accordance with rdc 2702019. Meaning is there a document that anvisa uses for particular requirement for active implantable medical devices and implantable medical devices. A summary of such classification is provided here below. Com user to receive detailed device specific compliance information for each market, including brazil, to expedite the preparation of your medical.
This is clearly a way to tell medical device companies that manufacturing in brazil might expedite the anvisa permit process. Manufacturers without a subsidiary in brazil which intend to place medical devices on the market there must obtain representation by a brazilian registration holder brh recognised by anvisa. Brazil, anvisa, regulatory, registration, resolution, health surveillance, public health introduction brazil is the largest country in south america with a. Anvisa has developed a set of essential requirements for medical device compliance, similar to those in the eu. Rdc 3052019 defines custommade device as any device intended for use by a specific patient or user, and that has been manufactured for that patient or user based on a healthcare providers prescription that includes specific device design features. As such, the process for the registration of medical devices in brazil has been partially harmonized with that of these countries. Alternatively, manufacturers can participate in the medical device single audit program mdsap. A declaration of conformity has replaced the gostr certificate for most medical devices. All medical devices shipped to brazil are checked by brazilian customs against the anvisa medical database for registration requirements and are allowed to enter brazil only if properly registered. Anvisa detailing all products imported andor manufactured for sale in brazil. The responsibility for submitting the application for approval together with the technical documentation with anvisa rests with the brh. The brazilian health surveillance agency anvisa south. The anvisa registration is always held by the agency that filed the application, exclusively for five years. Medical device registration process for all classes.