Products Registration

Vast majority of products used in health area in Brazil must pass by the approval of ANVISA (National Agency of Sanitary Surveillance) before being marketed. The products registration process at ANVISA is highly complex and demands intense dedication and knowledge. With the frequent changes of legislation and internal procedures at ANVISA, Vera Rosas Office, with its broad experience and living in the area, is able to provide a quality consulting service to obtain these registrations. To our clients’ peace, the follow up of the processes is done integrally, since the documentation gathering for the processes assembly until the publication in the Official Gazette. After this phase, the process renovation is also followed by our team. Vera Rosas Office files around 130 processes per month before ANVISA and acts in the following products areas subject to the Sanitary surveillance regimen: Medical products for health, Medical and electromedical equipment, Cosmetics, Drugs, Food, Sanitizing, Orthopedic implants, Odontological Products.

Companies Legalization

The first step in order to a company become qualified to act in manufacturing or distribution of products subjected to the Sanitary Surveillance in Brazil is to be duly regularized before ANVISA and other inspection bodies, like CFR, CRQ, CREA, the City Hall, Fire Departments, CETESB, and etc. Vera Rosas Office counts with a team of experienced professionals and in constant updating to give support to your company during its regularization in all licensing steps. Among the legalization services, the following is included: - plant choice or adequacy; - approval of installation projects; - protocol and follow up of permits/authorizations of operation/ Good Manufacturing Certifications until publication in DOU. The frequent changes of legislation and organizational structure that reach this area require the need of competent professionals capable to follow the processes in all theirs steps, to solve pending items and to deal with the Sanitary Surveillance agencies. The regularization of companies that manufacture, import, and distribute products, as well as to those that provide services subject to the Sanitary Surveillance regimen, is the first step so they can work in accordance with the sanitary legislation in force. Vera Rosas Office counts with a team of professionals with a lot of experience in obtainment of permits and authorizations needed to the companies operation. The frequent changes of legislation and organizational structure that reach this area require the need of competent professionals capable to follow the processes in all theirs steps, to solve pending items and to deal with the Sanitary Surveillance agencies.

Good Manufacturing / Distribution Practices and pré-inspection

On 05/22/09, RDC 25/09 was published by ANVISA. As determined in this RDC, the companies below must request before ANVISA the inspection for the Good Practices Certification and control. The companies that do not fulfill this normative will no longer be able to file products of these classes. The certificate started to be a mandatory item in the check-list of documents for registration and renewal of registrations. • Manufacturers of equipment and materials framed in the two classes with higher risk, III and IV; • Manufacturers of all in vitro diagnostic products framed in risk classes II, III, and IIIa; • Manufacturers of products from the enrollment exception list of risk classes I and II of IN no. 07/09. Vera Rosas Office has auditors capable to perform the pre-inspection work and guidance to obtain the Good Manufacturing and Distributions Practices Certification, required by the Sanitary Legislation in force. Our job consists in an initial Pre-Auditing of documentation and company’s infrastructure. After this step we elaborate a report that will contemplate all the improvement points and nonconformities detected. Next, we provide to the client a plan of strategic actions to adequacy and certification of the company. Besides the pre-auditing and the follow up during ANVISA inspection, our team prepares and helps in the implementation of all documentation of the Quality system (Good Practices manuals, operational procedures, Validation protocols, Registrations and collaborator’s Training). VERA ROSAS team provides this implantation service of the Good Practices system and the follow up of ANVISA auditing inside and outside of Brazil.

Certificate of Conformity – INMETRO

In accordance with the Sanitary Legislation in force, the Certificate of Conformity is a pre-requisite for the registration of household appliances before ANVISA. Our office, in a partnership with products certification companies, offers consulting services in the obtainment of the Certificate of Conformity, following up and intermediating the needed actions with the certification companies, pointing out the best options to the clients and providing the needed support. The Certificate is issued by Certifying Bodies Accredited by Inmetro – National Institute of Industrial Metrology. Certificates issued in other countries are not accepted. Our Office in a partnership with products certification companies, offers consulting services in the obtainment of the Certificate of Conformity, following up and intermediating the needed actions with the certification companies, pointing out the best options to the clients and providing the needed support.

Consulting Services

In addition to the regular services, our team provides consulting services and helps companies in the health area for differentiated projects, such as package insert conference, labeling change, among others. All professionals from Vera Rosas Office are able to provide Consulting Services in all fields of Regulatory Area, once they have a deep knowledge of the Sanitary Legislation in force. We analyze differentiated cases so that our clients always have all the support needed to be fitted in legislations and deliberations in force.