NATIONAL HEALTH SURVEILLANCE AGENCY  
www.anvisa.gov.br  
Public consultation No 10 of 5 March 2008  
Official Gazette of Brazil (DOU) of 06/03/2008  
Following a meeting held on 27 February 2008 , the Collegiate Board of t he National 
Health Surveillance Agency (ANVISA), pursuant to the powers conferred on it by 
Article 11, indent IV and Article 35 of the ANVISA Regulation approved by Decree No 
3.029 of 16 April 1999, and in accordance with Indent V and paragraphs 1 and 3 of  
Article 54 of the Internal Regulations approved under Annex I of ANVISA Order No 354 
of 11 August 2006, republishe d in the DOU on 21 August 2006 , 
Hereby announces the following public consultation and I, as Director -President, order 
its publication:  
Artic le 1  
A period of 60 (sixty) days is provided from the date of publication of this Public 
Consultation in which to submit criticisms and suggestion s concerning the annexed draft 
Technical Regulations for the grouping of materials for use in healthcare for the purposes 
of ANVISA registration . 
Article 2   
The full draft Technical Regulation s for the grouping of materials for use in healthcare 
for the purposes of ANVISA registration  will be available during the consultation period 
on the website www.anvisa.gov.br . Suggestions must be sent in writing to the National 
Health Surveillance Agency either by post (ANVISA, Gerência Geral de Tecnologia de 
Produtos  para Saúde, SEPN 515, Bloco B, Ed. Ômega, Asa Norte, Brasilia, DF,  CEP 
70.770.502), by fax (061 3448 1058) or by e -mail ( tecnologica.produtos@anvisa.gov.br ) 
with ‘grouping of materials for use  in healthcare’ in the subject field.  
Article 3   
At the end of the peri od indicated in Article 1, the National Health Surveillance Agency 
will liaise with the bodies involved and those that have expressed an in interest in the 
matter and ask them to nominate their representatives to take part in the subsequent 
discussions to establish the final wording of the decision.  
DIRCEU RAPOSO DE MELLO  
ANNEX  
DECISION OF THE COLLEGIATE BOARD – RDC No XX of XXXXX 2008  
Establishing th e technical regulations with  requirements for the grouping of materials for 
use in healthcare for the purpos es of ANVISA registration . 
The Collegiate Board of the National Health Surveillance Agency (ANVISA), pursuant 
to the powers conferred on it by Article 11, indent IV of the ANVISA Regulation 
approved by Decree No 3.029 of 16 April 1999, and in accordance wi th Indent II and 
paragraphs 1 and 3 of Article 54 of the Internal Regulations approved under Annex I of 
ANVISA Order No 354 of 11 August 2006, republished in the DOU on 21 August 2006, 
at a meeting held on XXXXXX 2008, and  evansjo  ENTR -2008 -00648 -00-00-EN-TRA -00 (PT)  
-2- Having regard to the health risk of materials for use  in healthcare ; 
Having regard to the need for new criteria for organising the grouping of these materials 
into systems, families and collections  for the purposes of ANVISA registration  
(exemption) ; 
Having regard to the need to define th e terms family, system, collection and compound 
single product  applicable to these materials;  
Having regard to the requirements that must be fulfilled by companies to request 
registration of these materials;  
Hereby adopts the following Decision of the Coll egiate Board and I, as Director -
President, order its publication:  
Article 1   
The Technical Regulations annexed to this Decision concerning the grouping of materials 
for use in healthcare for registration  purposes  is hereby approved.  
Article 2   
Made -to-meas ure materials for use in healthcare and orthopaedic implants shall be 
excluded from these Regulations.  
Article 3   
From the date of publication of this Decision , registration  (exemption) requests, for 
which protocol procedures will be carried out in ANVISA,  shall be subject to the 
provisions of this Decision and its Technical Regulations.  
Article 4   
Registration  requests granted in accordance with RDC Decision No 97/00 must be 
adapted to the Technical Regulations when revalidation requests are made.  
Sole par agraph   
Materials registered as single products may not be changed for registration as a family, 
collection  or system.  
Article 5   
Systems and collections of materials for use in healthcare must  have the same status as 
families for the purposes of collectin g health surveillance charges.  
Article 6   
In order to be grouped in families, materials for use in healthcare must  fulfil the specific 
criteria laid down by Regulatory Order.  
Article 7   
The codes associated with the models, parts, components and accessorie s of the materials 
for use in healthcare must be declared in the instructions for use and in the technical 
report presented in the documentation for the registration  (exemption) process or 
application, if applicable.  
Article 8   
The comparative table of the  commercial models, parts, components and accessories of 
the materials for use in healthcare must be presented in the documentation for the evansjo  ENTR -2008 -00648 -00-00-EN-TRA -00 (PT)  
-3- registration  (exemption) process, or application , in accordance with Article 10(2) of this 
Decision . 
Article 9   
Mate rials for use in health care with different concentrations, complying with all the 
general rules, may be grouped as a family.  
Article 10   
The general rules for the grouping of materials for use in healthcare as a family are laid 
down as follows:  
1. Product s classified as exempt from registration ( listed ) must belong to the same 
manufacturer or manufacturing group, be made from the same raw material and have the 
same instructions for use.  
2. Products subject to registration must belong to the same manufactur er or 
manufacturing group, be made from the same raw material and have the same 
manufacturing technology, activat ion mechanism, instructions for use, contraindication, 
adverse eff ects, precautions, restrictions , warnings, special care instructions, storage  
instructions and accessories for exclusive use. 
3. Sterile and non -sterile products may not be grouped in the same family.  
4. Disposable and non -disposable products may not be grouped in the same family.  
5. Products that may not be reprocessed or are lik ely to be reprocessed may not be 
grouped in the same family.  
6. The registration as a family of a collection  or system shall be prohibited.  
Article 11   
In order to comply with item XII of Part 3 of these Regulations, a deadline of 180 days 
shall be given f rom the date of publication of this Decision.  
Article 12   
The brand name of the healthcare product may not be misleading with regard to the type 
of group in which it is classified.  
Article 13   
This Decision shall enter into force on the day of its publicat ion. 
DIRCEU RAPOSO DE MELLO  evansjo  ENTR -2008 -00648 -00-00-EN-TRA -00 (PT)  
-4- ANNEX  
TECHNICAL REGULATIONS FOR THE GROUPING OF MATERIALS FOR 
USE IN HEALTHCARE FOR REGISTRATION  (EXEMPTION)  PURPOSES  
PART 1 – OBJECTIVE  
1.1 To establish the definitions and criteria for the grouping of materials for use in 
healthcare for the purposes of ANVISA registration  (exemption).  
PART 2 – DEFINITIONS  
2.1 The definitions listed below shall apply  only for the purposes of this Decision and 
may have other meanings in other contexts.  
2.1.1 FAMILY OF PRODUCTS – a grouping of pr oducts that may belong to the same 
register or directory and that fulfil established general criteria and, if applicable, specific 
criteria.  
2.1.2 COMPOUND SINGLE PRODUCT  – single -purpose product, made up of two or 
more elements, from one manufacturer  or m anufacturing group, which work 
interdependently to carry out the function and role for which the product  is intended.  
2.1.3 SYSTEM – product from  the same manufacturer or manufacturing group , made up 
of complimentary and compatible components for use only with each other, for a s ingle  
specific purpose, which work  interdependent ly to carry out the system’s function, the 
product being intended for a specific procedure and t he performance of which can be 
achieved  only if used in an integrated way.  
2.1.4 COLLEC TION (kit, set or tray)  – grouping of products used in a specific procedure 
and which, on their own, do not work interdependently  to carry out the function and role 
for which the collection is  intended.  
2.1.5 ACCESSORY – product manufactured exclusively to be part of  a medicinal 
product, giving the latter an additional technical function or characteristic.  
2.1.6 COMMERCIAL PRESENTATION – all the way s in which the product will be 
presented for use, including the description of the format and content of the p ackag ing. 
2.1.7 HEALTH PRODUCT PART – component manufactured exclusively to be part of a  
health care product, without which the product is functionally deficient or inoperative.  
2.1.8 INSTRUCTIONS FOR USE – specification of the intended use of the health care 
material s. 
2.1.9 SURGICAL INSTRUMENT – equipment for use in healthcare used as a 
mechanical device  to carry out surgical procedures in order to cut, pierce, saw, grind, 
lacerate, clamp, remove, pinc h or carry out any other similar procedure , with no link  to 
any other active medicinal  product.  
2.1.10 ARTICULATED SURGICAL INSTRUMENT – surgical instrument with one or 
more axes  via which the parts , connected by an articulation joint, move.  evansjo  ENTR -2008 -00648 -00-00-EN-TRA -00 (PT)  
-5- 2.1.11 SURGICAL CUTTING INSTRUMENT – surgical instrument that can cut,  
perforate, scrape  or section.  
2.1.12 ACTIVATION  MECHANISM – operating  principle of a product used in 
healthcare , the way  the product  acts or interacts with the body  to achieve its intended 
purpose.  
2.1.13 RAW MATERIAL – substances used in the manufacture of health products, 
including both substances  that remain unchanged and those that are likely to be altered. 
2.1.14 TRACEABILITY LABEL - additional document to be provided with the product 
or system, containing a field  in which to insert  the following info rmation: brand name or 
model, manufacturer or importer identification, system product code or system 
component code, batch number  and ANVISA registration number.  
PART 3 – GENERAL RULES FOR FAMILIES, SYSTEMS AND COLLECTIONS  
I. Materials for use in healthcar e presenting only variations  in size shall be considered as 
a family of materials , with the se variations being considered as  family models.  
II. Variations in colour, smell and taste shall be considered as forms of commercial 
presentation, and shall not be characterised as a family of materials . 
III. Families of  compound single product s shall be accepted , provided they fulfil  the 
general and specific criteria if applicable.  
IV. For sales purposes , the components of a compound single product  may not be 
presen ted separately even if it is for the purposes of replacement.   
V. For the purposes of replacement, the components of a system may be marketed  
separately, provided they are for use only with  the system.  
VI. The label and instructions for use of a system’s replacement component must include 
the system’s brand name , the name of the replacement component , as indicated in the 
registration process , and the wording ‘replacement component for use  only in the 
system ’. 
VII. The components of a system and a collectio n may have different risk categories, the 
highest risk category always applying . 
VIII. Variations in size of  components of a system shall be considered as a form of 
commercial presentation and shall not characterise a family of systems.  
IX. For the purpose s of amending the register, it sha ll not be possible to include  
components in a system or collection  or exclude them from one . 
X. Variations  in size and quantity of components of a collection shall be characterised as 
a form of commercial presentation, pro vided that no component of this collection is 
excluded.  
XI. Accessories must be common to all family models . 
XII. The supplier must make available the traceability labels identifying each material or 
implantable system component, so that the label can be attached  mandatorily to the evansjo  ENTR -2008 -00648 -00-00-EN-TRA -00 (PT)  
-6- clinical reference book, the document to be given to  the patient and  the tax collection 
documentation. Such labels must also be made available for the checks carried out by the 
supplier and by the responsible surgeon. A total of 5 labels must therefore be provided.