Adverse event
Definition: An unwanted effect in humans resulting from the use of products subject to health surveillance.
Scope. Definition in RDC 67 (technovigilance).
Where it appears
Regulatory glossary
What the terms mean and where they appear on the group’s pages.
Glossary index
Glossary index
These explanations summarize the cited sources. The English text is our translation; consult the official Portuguese text for the full wording of the regulations.
A
AE
Full name: Special Authorization
Definition: An act within the authority of the Brazilian Health Regulatory Agency that authorizes activities involving pharmaceutical inputs, medicines and substances subject to special control, as well as the cultivation of plants that may yield substances subject to special control, upon proof of specific technical and administrative requirements set out in the resolution.
Scope. Required for activities involving substances, plants and fungi subject to special control, under article 4 of RDC 16.
Where it appears
AFE
Full name: Operating Authorization
Definition: An act within Anvisa’s authority, containing authorization for companies or establishments, institutions and bodies to operate, granted upon compliance with the technical and administrative requirements set out in the resolution.
Scope. It authorizes the company, not the product. Required for each company that manufactures, imports, stores, distributes or transports medicines, pharmaceutical inputs, cosmetics, hygiene products, perfumes and sanitizing products (article 3), and for each establishment in the case of health products. Food companies do not receive an AFE from Anvisa.
Where it appears
Anvisa
Full name: Brazilian Health Regulatory Agency
Definition: An autonomous government agency under a special regime, linked to the Ministry of Health, with headquarters and jurisdiction in the Federal District and operations throughout Brazil (article 3). Its institutional purpose is to promote the protection of public health through sanitary control of the production and marketing of products and services subject to health surveillance (article 6).
Scope. Law 9.782/1999.
Where it appears
C
CBPF
Full name: Good Manufacturing Practices Certificate
Definition: A document issued by Anvisa certifying that a given establishment complies with the technical Good Manufacturing Practices requirements set out in current legislation, necessary for marketing the product.
Scope. The applicant is a legal entity legally established in Brazil (article 3, XII). The regulation applies to manufacturers in Brazil and abroad (article 2).
Where it appears
G
GMP
Full name: Good Manufacturing Practices
Definition: For medical products and in vitro diagnostic products: requirements describing GMP for methods and controls used in design, purchasing, manufacturing, packaging, labeling, storage, distribution, installation and servicing; they aim to ensure that products are safe and effective (paragraph 1).
Scope. This definition applies to medical products (RDC 665). Each category, such as medicines, cosmetics and sanitizing products, has its own GMP regulation.
Where it appears
Grade 1 and Grade 2 (cosmetics)
Definition: Personal hygiene products, cosmetics and perfumes that, due to their area of application, target users, specific formulation conditions or the health impact of their stated intended uses, initially require a lower degree of health surveillance (Grade 1) or a higher degree (Grade 2), according to the indicative lists in Annex I.
Scope. Wording introduced by RDC 949. Grade alone does not determine registration or prior communication: the route follows the groups in article 34 (articles 34 and 35 of RDC 907).
Where it appears
H
Health surveillance
Definition: A set of actions capable of eliminating, reducing or preventing health risks and intervening in health problems arising from the environment, the production and circulation of goods and the provision of services of health interest, encompassing control of consumer goods related to health, from production to consumption, and control of the provision of health-related services.
Scope. Law 8.080/1990.
Where it appears
I
Importer
Definition: A public or private legal entity responsible for importing medical devices from abroad into Brazilian territory.
Scope. Definition in RDC 751. Importers bringing products in for sale must request an extension of their AFE to include distribution.
Where it appears
IN
Full name: Normative Instruction
Definition: A normative act that, without introducing new rules, guides public officials in implementing current regulations.
Scope. Definition in Anvisa’s Internal Rules. IN 281 lists food categories by regulatory route (RDC 843, article 3).
Where it appears
L
Legal manufacturer
Definition: A public or private legal entity responsible for the design, manufacture, packaging and labeling of a product, with the intention of making it available for use under its name, whether these operations are performed by the company itself or by third parties on its behalf.
Scope. A notification or registration application includes a declaration from the legal manufacturer authorizing the applicant company to represent it in Brazil (articles 13, II; 14, III; 27, I).
Where it appears
M
Medical device
Definition: An instrument, apparatus, equipment, implant, in vitro diagnostic medical device, software, material or other article intended by the manufacturer to be used, alone or in combination, in human beings for specific medical purposes (diagnosis, prevention, monitoring, treatment or alleviation of disease, among others listed in the regulation), and whose principal intended action is not achieved by pharmacological, immunological or metabolic means in the human body.
Scope. RDC 751 treats “medical device” and “medical product” as the same term (article 4, X). RDC 67 uses “health product”.
Where it appears
N
Notification (medical devices)
Definition: The act of informing Anvisa of the intention to market a medical device, intended to establish the right to manufacture and import a medical device exempt from registration under paragraph 1 of article 25 of Law 6.360/1976 and classified as risk class I or II, indicating its name, manufacturer, intended purpose and other defining elements.
Scope. Definition in RDC 751. For risk 1 sanitizing products, the regulation also uses “notification” (RDC 989, article 8), with its own rules.
Where it appears
P
Pharmacovigilance
Definition: The science and activities relating to the detection, assessment, understanding and prevention of Adverse Events or other medicine-related problems.
Scope. Definition in RDC 406, which addresses Good Pharmacovigilance Practices for medicine registration holders.
Where it appears
Prior communication (cosmetics)
Definition: A procedure with Anvisa to which personal hygiene products, cosmetics and perfumes belonging to groups not listed in article 34 are subject, and which are therefore exempt from registration.
Scope. Distinct from the “communication of the start of manufacturing or importation” for food, which is submitted to the state, Federal District or municipal health authority (RDC 843, article 3, III).
Where it appears
R
RDC
Full name: Collegiate Board Resolution
Definition: An act expressing a collegiate decision to issue normative acts on matters within the Agency’s authority, with provision for penalties in the event of non-compliance.
Scope. Definition in Anvisa’s Internal Rules (RDC 585).
Where it appears
Registration (medical devices)
Definition: An act reserved to Anvisa intended to establish the right to manufacture and import a product subject to Law 6.360/1976 and classified as risk class III or IV, indicating its name, manufacturer, intended purpose and other defining elements.
Scope. Definition in RDC 751. Valid for 10 years and renewable (article 11). Under Law 6.360, “registration” is entry in a dedicated register following the authorization decision by the head of the Ministry of Health body (article 3).
Where it appears
Registration holder (MAH)
Definition: Holder of notification or registration: a public or private legal entity, manufacturer or importer, responsible for the medical device in Brazil, which holds the authorization to market the medical device issued by Anvisa.
Scope. In technovigilance, the registration holder holds the health product’s registration with Anvisa and is its legal representative (RDC 67, article 3). “MAH” is not a term in the Brazilian regulation; it is the term used by Ávita Care.
Where it appears
Risk class (medical devices)
Definition: Medical devices are classified according to the intrinsic risk they pose to the health of the user, patient, operator or other people involved: Class I, low risk; Class II, medium risk; Class III, high risk; Class IV, maximum risk.
Scope. It determines the route: classes I and II, notification (article 6); classes III and IV, registration (article 7). Cosmetics use Grades 1 and 2; sanitizing products use risks 1 and 2.
Where it appears
S
Sanitary license
Definition: A document issued by the competent health authority of the states, the Federal District or municipalities, specifying the activities subject to health surveillance that the establishment is qualified to perform.
Scope. It complements Anvisa’s AFE; for food businesses, it is what the establishment obtains instead of an AFE.
Where it appears
Sanitizing product
Definition: A substance or preparation intended for application to inanimate surfaces, textiles, objects and environments, for cleaning and related purposes, with antimicrobial action and for pest control, for use in homes and in shared public or private environments, including products for disinfecting drinking water and swimming pool water.
Scope. Classified by risk: risk 1 (notification) and risk 2 (registration), under article 8 of RDC 989.
Where it appears
T
Technical complaint
Definition: A notification of a suspected change or irregularity in a product or company relating to technical or legal aspects, which may or may not cause harm to individual or public health.
Scope. Definition in RDC 67.
Where it appears
Technical dossier
Definition: A document describing the elements that make up the product, indicating its characteristics, intended purpose, method of use, contents, special precautions, potential risks, manufacturing process and additional information.
Scope. Definition in RDC 751, for medical devices.
Where it appears
Technical officer
Definition: A legally qualified higher-education professional, trained in the technologies making up the product, responsible for the technical information submitted by the applicant (manufacturer or importer) and for the quality, safety and performance of the marketed product.
Scope. Definition in RDC 751. For an AFE (RDC 16): a professional legally qualified by the respective professional council for the activity performed by the company (article 2, XX).
Where it appears
Technovigilance
Definition: A surveillance system for adverse events and technical complaints concerning health products in the post-marketing phase, aimed at recommending measures that ensure the protection and promotion of public health.
Scope. Applies to health product registration holders based in Brazil (article 1).
Where it appears
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