National Health Surveillance Agency  
www.anvisa.gov.br  
Public Consultation No 2 of 13 January 2009. 
Official Gazette of 17/2/09  
The Board of the National Health Surveillance Ag ency (ANVISA), in the exercise of the powers 
granted by Article 11(IV) and Article 35 of ANVISA’ s Regulations, approved by Decree No. 3029 of 16 April 
1999, and Having regard to the provisions of Article 54(1) , (3) and (V) of the Internal Regulations approved in 
accordance with Appendix I of ANVISA Administrati ve Ruling No. 354 of 11 August 2006, republished in the 
Official Gazette of 21 August 2006, at a meeting held on 3 February 2009, 
hereby adopts the following Public Consultation, a nd I, the Director-President, order its publication: 
Article 1 - Criticism and suggestions concerning the attached proposal for a resolution that 'sets out 
technical surveillance standards applicable to health product registration holders in Brazil' may be submitted 
up to 60 (sixty) days from the date of pub lication of this Public Consultation. 
Article 2 - The full text of the draft Resolution will be available throughout the entire consultation period 
on the following web-site: http://www.anvisa.gov.br/di vulga/consulta/index.htm. Suggestions should be 
submitted in writing to the following address: Agência Na cional de Vigilância Sanitária, SIA Trecho 5, Área 
Especial 57, Bloco D, 1 Andar, UTVIG/NUVIG. Caixa Po stal 11617, Brasília - DF, CEP 71205-050, e-mail: 
cp2.tecnoviglancia@anvisa.gov.br  
Article 3 - After the period stipulated in Article 1 has elapsed, the National Health Surveillance Agency 
will contact the bodies and entities involved and any other interested parties for them to appoint 
representatives for the subsequent discus sions on consolidating the final text. 
DIRCEU RAPOSO DE MELLO  
ANNEX 
RESOLUTION OF THE COLLEGIATE DIRECTORATE (RDC) NO xxx OF xx xxxx 2009  
setting out technical su rveillance standards 
applicable to health product registration holders in 
Brazil 
The Board of the National Health Surveillance Agency , in the exercise of the powers granted by 
Article 11(IV) and Article 35 of ANVISA’s Regulatio ns, approved by Decree No. 3029 of 16 April 1999, and 
Having regard to the provisions of Article 54(1), (3) and (V) of the Internal Regulations approved in 
accordance with Appendix I of ANVISA Administrati ve Ruling No. 354 of 11 August 2006, republished in the 
Official Gazette of 21 August 2006,  at a meeting held on [date], and 
Having regard to Article 197 of the 1988 Federal Co nstitution, on the importance of health actions and 
services, and laying down the responsibility of the public  authorities in regulating, supervising and monitoring 
these actions and services; 
Having regard to Law No 6 360 of 23 September 1976, on the health surveillance applicable to 
medicines, drugs, pharmaceutical and related ingr edients, cosmetic, healthcare and other products; 
Having regard to Law No 6 437 of 20 August 1977, se tting out infringements of federal health law, 
establishing the relevant penalties, and laying down other provisions; 
Having regard to Law No 9 782 of 26 January 1999, def ining the National Health Surveillance System, 
creating the National Health Surveillance Agency, and laying down other provisions; 
 Having regard to Law No 8 078 of 11 September 1990, on consumer protection and laying down 
other provisions; 
Having regard to Decree No 686 of 27 August 1998, ordering all manufacturers of diagnostic products 
for in vitro  use to comply with the directives laid down in the 'Good manufacturing and monitoring practices in establishments manufacturing diagnostic products for in vitro  use'; 
Having regard to RDC No 59 of 27 June 2000, which orders all suppliers of health products to comply 
with the requirements laid down in the 'Good prac tices in the manufacture of health products'; 
Having regard to RDC No 56 of 6 April 2001, which lays down the essential safety and effectiveness 
requirements applicable to health products; 
Having regard to RDC No 185 of 22 October 2001, which deals with the registration, amendment, 
renewal and cancellation of records in the medical product register with the Agência Nacional de Vigilância 
Sanitária  – ANVISA (National Heal th Surveillance Agency); 
Having regard to RDC No 167 of 2 July 2004, which provides for an inspection procedure to monitor 
compliance with the 'Good practices in establishments manufacturing diagnostic products for in vitro  use'; 
whereas it is necessary to update the technical re gulation for the post-market surveillance of health 
products; 
whereas it is necessary to lay down rules for notifyi ng adverse events and technical defects relating to 
the use of health products by registration holders; 
has adopted the following Board Resolution and I, t he Director-President, order its publication: 
INITIAL PROVISIONS  
Article 1 – This Resolution lays down the general te chnical surveillance requirements to be adopted by 
all health product registration holders based in Brazil. 
Article 2 – For the purposes of th is Resolution, technical surveillanc e means the system for monitoring 
adverse events and technical defects relating to health products at the post-market stage, with a view to 
recommending the adoption of measures intended to protect and promote human health. 
Article 3 – All definitions applicable to this Resolution are given in Annex I. 
Article 4 – Examples of non-serious adverse event s and technical defects liable for notification are 
given in Annex II. 
Article 5 – This Resolution will enter into  force 180 days after its publication. 
GENERAL CONDITIONS  
Article 6 – The health product registration hold er must formally appoint a university-educated 
professional, registered with the professional council,  to take charge of technical surveillance at the 
company. 
Article 7 – The health product registration holde r must arrange and set up a technical surveillance 
system in the company, in order to: 
I- provide the resources required for complying with this Resolution;  
II- standardise, and ensure compliance with, the protocols and procedures to be followed in the 
area of technical surveillance, in line with the company's quality system;  
III- ensure the accurate analysis or management of the risk associated with its products;  
IV- ensure that all professional duties and responsib ilities are formally descr ibed, disseminated and 
understood by those involved in technical surveillance activities;  
V-  prepare, conduct, monitor and continuously assess training for those involved in the activities 
described in this Resolution;  
VI- supply the protocols, proce dures and other docu ments relating to technical surveillance 
whenever these are requested by the Sistema Nacional de Vigilância Sanitária  – SNVS (National Health 
Surveillance System);  
VII- process and record information relating to the occurrence of adverse events, technical defects, 
warnings and field work relating to products registered in the registration holder's name;  
VIII- assess information relating to the occurrence of  adverse events, technical defects, warnings and 
field work so that such occurrences can be invest igated according to their seriousness and risk level;  
IX- notify the SNVS of adverse events and technica l defects of which the registration holder 
becomes aware and which fall within the categories re ferred to in Articles 8 and 9 of this Resolution;  
X- keep an up-to-date, accurate record of notificat ions received, analysed and investigated, in order 
to ensure that information relating  to the technical surveillance measur es implemented by the company is traceable, and that data can be retrieved quickly;  
XI- provide the notifier, in writing, with the outcome  of the investigation into the notification, along 
with supporting evidence.  
XII- Comply with other relevant laws relating to  the health surveillance of health products.  
Article 8 – For the purposes of te chnical surveillance, the following  events relating to the health 
product must urgently be assessed by the registration holder: 
I. death associated with the use of health products;  
II. suspicion of serious threat to public health;  
III. serious adverse event involving a patient, user or other person;  
IV. occurrence that could cause death or an adver se event in a patient, user or other person;  
V. non-serious adverse event involving a patient, user or other person;  
VI. occurrence that could cause a non-serious adver se event in the patient, user or other person.  
NOTIFICATION OF EVENTS AND TECHNICAL DEFECTS  
Article 9 – The health product registration holder must notify the SNVS immediately of the health-
product-related adverse event, within a maximum of ten days of becoming aware of it, if the occurrence falls 
under one of the following categories: 
I. Serious adverse event, whether or not resulting in death.  
II. Non-serious adverse event, any recurrence of which could cause serious harm or death to the 
patient, user or other person.  
Sole paragraph:  Where there is either suspicion or conf irmation that the adv erse event was brought 
about by the use of the health pr oduct, the SNVS must be notified. 
Article 10 – The health product registration holder must notify the SNVS immediately of the suspicion 
or confirmation of a serious threat to public health invo lving the health product, or within a maximum of ten 
days of becoming aware of it. 
Article 11 – The health product registration holder must notify the SNVS immediately of a technical 
defect in a health product that coul d cause a serious adverse event in pat ients, users or other persons, or 
within a maximum of 30 days of becoming aware of it, if: 
I. there is a real possibility that  the technical defect will recur;  
II. an occurrence of the same kind has already caus ed or contributed to death or serious harm in 
the last two years;  
III. the product registration holder needs to  take steps to prevent a health risk;  
IV. there is the possibility of in correct use due to unsuitable de sign, labelling an d instructions.  
Article 12 – The health product registration holder mu st notify the SNVS immediately if counterfeiting 
of the health product is suspected, within a maximum of ten days of becoming aware of it. 
 Article 13 – Adverse events and technical defects are exempt from notification if they fall within at 
least one of the categories below: 
I. Regardless of whether precautions are included in the instructions for use provided with the 
product, the user can normally detect the technical def ect before using the product. This condition is valid 
only when there has been no adverse event as a result of the product's non-compliance.  
II. Adverse events caused by the patient's health: the registration holder discovers that the root 
cause of an adverse event is a condit ion from which the patient suffers, whether it existed before the patient 
used the product or was acquired while the patient was using it. In order to justify such an exemption from 
notification, the registration holder must have informat ion at his disposal proving conclusively that the 
product did not cause or contribut e to the adverse event. That conc lusion must be substantiated by a 
medical expert.  
III. When the sole cause of the oc currence was that the product wa s used after the expiry date set 
by the manufacturer had passed.  
IV. The product has a protection device against a defect that would pose a risk to a patient, user or 
other person, and that device worked properly, thus prev enting the occurrence of a serious adverse event.  
V. Predicted and expected occurrences, clearly iden tified on the label or instructions, which are 
quantitatively and qualitatively predictable wh en the device is used as recommended.  
VI. When the product is used for a purpose other than that stated by t he manufacturer, or the 
instructions or warnings shown on the label were not followed, and this did not cause a serious adverse 
event.  Sole paragraph : Occurrences that do not fall under any of the categories described in this article 
should be assessed according to Articles 8, 9 and 10 to determine whether or not notification is necessary. 
Article 14 – Notifications of adverse events and te chnical defects should be made via the information 
system officially adopted by ANVISA, namely the Sistema de Notificação em Vigilância Sanitária  – 
NOTIVISA (Health Surveillance Notification Sy stem), available on the ANVISA website at 
www.anvisa.gov.br. 
FINAL PROVISIONS  
Article 15 – When the registration holder notifies  the SNVS of an adverse event or technical defect, 
the registration holder becomes, in prin ciple, responsible for any events caus ing harm to others as a result of 
the use of the health product(s) referred to in the notification. 
Article 16 – Without prejudice to other legal penalties, including criminal penalties, for which technical 
and legal staff may be liable, the company will, under administrative and civil law, be liable for health 
infringements arising from non-compliance with this Resolution and other supplementary standards pursuant 
to Law No 6437/77. 
Article 17 – ANVISA's technical surveillance unit (U TVIG/NUVIG) must, as part of its powers, adopt 
measures or procedures for eventualities not provided for in this Resolution. 
DIRCEU RAPOSO DE MELLO  
ANNEX I – DEFINITIONS 
Risk analysis: Systematic use of available information to  identify dangers and to assess levels of 
harm. 
Health product registration holder: Registration holder of a particular health product with ANVISA. 
Adverse event: Harm to the health of a user or patient that occurs when a product has been used 
according to the conditions and parameters laid down by  the manufacturer in the process of registering the 
product with ANVISA/Ministry of Health. 
Serious adverse event: Adverse event that leads to at least one of the following: 
(a)  death; 
(b) permanent disability or harm to a structure of the human body; 
(c) medical or surgical treatment to prevent perm anent harm to a function or structure of the human 
body; 
(d) hospitalisation or extension of hospitalisation; 
(e) a disturbance or risk to the foetus, foetal  death or a congenital disorder or birth defect. 
Instructions for use: Manuals, brochures and other document s accompanying the health product, 
containing technical information on the product. 
NOTIVISA: Sistema de Notificações de Produtos sob Vigilância Sanitária  (Notification System of 
Products under Health Surveillance), avail able on the web at http://www.anvisa.gov.br . 
Health product: Product that falls under at least one of these three categories: 
(a) Medical Products  – Health products such as equipment, apparatus, materials, articles or 
systems for medical, dental or laboratory use intended for prevention, diagnosis, tr eatment, rehabilitation or 
contraception, which do not use pharmacological, imm unological or metabolic means to perform their main 
function in human beings, though such means may be used to assist in those functions.  
(b) Diagnostic products for in vitro use  – Reagents, gauges, calibrators, controls, materials, 
articles and instruments (along with the instructions fo r the use thereof) that are us ed to evaluate qualitative, 
quantitative or semi-quantitative samp les from the human body; such products are not intended to perform 
an anatomic, physical or therapeutic function and are not  ingested, injected or inoculated in human beings, 
but are used solely to provide information regarding samples obtained from the human body.  
Technical defect:  Technical or legal alteration to, or irregularity of, a product or business, which may 
or may not cause harm to individual or collective health. Risk: Combination of the probability of the occurrence  of harm and the seriou sness of that harm. 
Traceability: Ability to describe the history, application, processes and location of a product in a 
particular organisation by means of registers and identification. 
Serious threat to public health: Any kind of occurrence resulting in the imminent risk of death, 
serious injury or serious illness requiring urgent action. 
SNVS: Sistema Nacional de Vigilância Sanitária  (National Health Surveillance System), comprising 
the Ministry of Health, the Agência Nacional de Vigilância Sanitária  – ANVISA (National Health Surveillance 
Agency), State and Municipal Health  Surveillance Centres (Visas), Laboratórios Centrais de Saúde Pública  – 
LACENS (Central Public Health Laboratories), the Instituto Nacional de Controle de Qualidade em Saúde  – 
INCQS (National Institute for Quality Control of Health) and the Oswaldo Cruz Foundation – FIOCRUZ. 
Technical surveillance: the surveillance system of adverse events an d technical defects  relating to 
health products at the post-market stage, with a view to recommending the adoption of measures to protect 
and promote public health. 
ANNEX II – EXAMPLES OF NON-SERIOUS NO TIFIABLE ADVERSE EVENTS  AND TECHNICAL 
DEFECTS 
A. Notification of non-serious adverse events with  the potential to harm the user, patients or 
other persons.  
Adverse events do not always resu lt in death or serious injury. Such an outcome may be averted due 
to circumstances or to the timely intervention of heal th personnel, but a fresh occurrence of the same kind 
may result in a serious adverse event, whether fatal or not. In such cases, the adverse event, although 
classified as non-serious , must be notified. 
Relevant information that may help understand or evaluate the adverse event should be included in 
the notification. Before the occurrence of an adverse ev ent is notified, the notifier must try to confirm – by 
means of a preliminary eval uation – that the event was 
 due to inherent problems with the equipment, thus ruling out other possible causes that do not have to be 
notified pursuant to this Resolution (i.e. incorrect use, elapsed expiry date, outcome of the event unrelated to 
equipment) 
Below are some examples of adver se events that can be classified as  non-serious but that, in the 
event of recurrence, may bring about a serious adverse event. 
Examples of notifiable non-serious adverse events  
A.1) In a vascular radiography system, the arm of the radiography equipment makes an uncontrolled 
movement while a patient is being examined. The patient is struck on the head by the image intensifier and 
sustains slight bruising. The system was installed correctly, its maintenan ce record was up to date and it was 
being used in accordance with the manufacturer's instructions. In accordance with the risk assessment 
carried out, a fresh occurrence of this kind may result in a fractured skull or face. 
A.2) Due to a malfunction, an infusion pump supplie s a volume 20% greater than that set, but there is 
no alarm to warn that this is taking place. The pati ent, a 32-year old adult, receives a higher quantity of the 
required solution but this only causes him slight discom fort. The risk assessment concludes that if this pump 
is used for infusion in a new-born baby and the problem  recurs, there is a strong possibility of a serious 
adverse event occurring. 
B. Notification of technical defects with the potential to harm the user, patients or other 
persons.  
By definition, a technical defect is the technical or legal alteration to, or irregularity of, a product, which 
may or may not harm individual or collective health. Where a technical defect reveals the potential to harm a 
person, and where this harm may manifest itself in t he form of a serious adverse event, the technical defect 
must be notified. 
Below are some examples of technical defects wi th the potential to cause a serious adverse event. 
Examples of notifiable technical defects  B.1) A system for holding a monitor in place falls from its support when its screws break. No one is 
injured in the operating theatre on this occasion, but not ification is necessary given the potential for harm if 
the problem recurs. The system was installed correctly, its maintenance record was up to date and it was 
being used in accordance with the manufacturer's instructions. 
B.2) After an orthopaedic implant has been placed on t he market, it is discovered that mistakes were 
made in the manufacturing process, which led to material properties failing to comply with standards, 
resulting in a risk to public health. 
B.3) The manufacturer fails to provide sufficient info rmation in the instructions regarding the cleaning 
of reusable surgical instruments.