ISSN 1677-7042 
Official Gazette of Brazil – Section 1 
No 245, Wednesday 23 December 2009 
COLLEGIATE BOARD RESOLUTION NO 69 OF 21 DECEMBER 2009. 
Laying down instructions on the registration, ma nufacture, quality control, marketing and 
use of intrauterine devices (IUDs) containing copper. 
The Board of the National Health Surveillan ce Agency, in the exercise of the powers 
granted by item IV of Article 11 of the Regulation approved by Decree No 3029 of 16 
April 1999, and having regard to the provi sions of item II and points (1) and (3) of 
Article 54 of the Internal Regulations approved in accordance with Annex I of ANVISA 
Administrative Order No 354 of 11 August 2006, republished in the Official Gazette of 
21 August 2006, at a meeting held on 16 December 2009, hereby adopts the following Collegiate Board Resolution and I, the Di rector-President, order its publication: 
Article 1. The Technical Regulation on the re gistration, manufacture, quality control, 
marketing, use and instructions for the user s of intrauterine devices (IUDs) containing 
copper is hereby approved. 
CHAPTER I 
INITIAL PROVISIONS 
Section I 
Objective 
Article 2. This Regulation lays down instru ctions on the registration, manufacture, 
quality control, marketing, use and instructi ons to users of intrauterine devices (IUDs) 
containing copper. 
Section II 
Scope 
Article 3. This Regulation applies to intr auterine devices (IUDs) containing copper, 
excluding the other materials used in healthcare. 
Section III 
Definitions  
Article 4. For the purposes of this Techni cal Regulation the following definitions are 
hereby adopted: 
I - Intrauterine contraceptive device - I UD: device containing copper for insertion 
in the uterine cavity for the purpose of preventing pregnancy. 
II - Applicator components: components used  to insert the IUD in the uterine cavity. 
III: - Suture: attachment to the IUD used to verify the presence and permit the 
removal of the IUD. IV - Viscoelasticity or memory: property of the IUD enabling it to return to 
approximately its original shape after deformation. 
V - Active surface area: exposed copper surf ace of the IUD, intended to come into 
contact with uterine fluids. 
Section IV 
Reference standards 
Article 5. For the purposes of this Technical Regulation the following standards are 
hereby adopted as references: 
I - Collegiate Board Resolution No 185 of  22 October 2001 laying down provisions 
on the creation, modification, revalidation and cancellation of regist ration of medicinal 
products. 
II - ISO 7439 Copper-bearing intra-uterine contraceptive device s - Requirements 
tests. 
III - ISO 14155 Clinical investigation of  medical devices for human subjects. 
IV Collegiate Board Resolution No 56 of  06 April 2001 laying down provisions on 
the essential requirements as regards safety  and effectiveness applicable to health 
products. 
CHAPTER II 
GENERAL REQUIREMENTS 
Section I 
Shape of the IUD 
Article 6. When examined by vi sual inspection and by touch IUDs should be shaped to 
adapt to the uterine cav ity and to minimise the risk of perforation. 
Article 7. Neither IUDs or insertion instruments should have sharp points. 
Article 8. IUDs which require an insertion in strument for correct application must be 
supplied with the said instrument.  
Section II 
Dimensions 
Article 9. The nominal length of an IUD ma y not exceed 36 mm, and the nominal width 
may not exceed 32 mm. 
Article 10. The dimensions of the IUD should be consistent with the manufacturer’s 
specifications, with a tolerance of +/- 5% relative to the value specified. 
Article 11. The area of the nominal active copper surface should be at  least 200mm2 and 
no more than 380mm2. 
Article 12. Any copper wire used must have a diameter of at least 0.25 mm. Article 13. The diameter should be consistent with the manufacturer's specifications with 
a tolerance of +/- 5%, while the area of the active surface  should be within a tolerance of 
+/- 10% relative to th e specified value. 
Article 14. The area of the copper surface should be calculated on the basis of the 
measurements of the diameter and length of the copper wire. 
Article 15. The length of the wire connected to the underside of th e plastic body must be 
at least 100 mm. 
Article 16. The external diameter  of any part of an inserti on instrument intended to come 
into contact with the cervical canal should be no more than  5mm and within a tolerance 
of +/- 5% relative to the specified value. 
Section III 
Tensile strength 
Article 17. The IUD, including the wire, must withstand a tensil e force of at least 12 N. 
Section IV 
Stability 
Article 18. IUDs should maintain all the charac teristics declared by manufacturers for the 
entire period of validity laid down if  the storage conditions laid down by the 
manufacturer are met. 
Article 19. IUDs, including th eir copper components, should maintain their structural 
integrity for the whole period of us e declared by their manufacturers. 
Article 20. Within the period laid down for use, on removal, IUDs should meet the 
specifications of Article 18. 
Section V 
Resistance to deformation 
Article 21. During the test of resistance to deforma tion under simulated conditions of 
insertion, the IUD must return  to its original shape. 
Article 22. Residual deformation must be no more than 5 mm. 
Section VI 
Detection in situ 
Article 23. All parts of IUDs must be dete ctable by radiological examination (X-ray). 
Article 24. When barium sulfate is used to make the plastic components radiopaque, the 
concentration must be between  15% (p/p) and 25% (p/p). 
Section VI 
Sterility Article 25. IUDs and insertion inst ruments must be supplied sterile. 
Section V 
Materials 
Article 26. The plastic body of IUDs should be viscoelastic, compliant with Articles 22 
and 23, biocompatible and nonabsorbable. 
Article 27. The wire should be bi ocompatible and nonabsorbable. 
Article 28. The copper used shoul d be at least 99.9 % pure. 
Section VI 
Labelling 
Article 29. The labelling for the marketing and use of IUDs should meet the requirements 
of ANVISA Collegiate Board Resolution No  185 of 22 October 2001 or any measure 
which replaces this. 
Section VII 
Instructions for use 
Article 30. IUDs must be supplied with inst ructions for use which comply with ANVISA 
Collegiate Board Resolution No 185 of 22 Oc tober 2001 or any measure which replaces 
this. 
Sole paragraph. The instructions for use must contain information for the medical 
professional, including: 
I - The international generic name of the product and desc ription of the model with 
dimensions and composition; 
II - A description of the intended use; III - The recommended time for insertion after an abortion, childbirth or coitus; 
IV - A description of the insert ion procedure with  illustrations; 
V - The maximum time the IUD may remain  in the insertion instrument and the 
maximum time the IUD may remain in situ; 
VI - A description of the removal proce dure and steps to take  in the event of 
difficulties during removal; 
VII - Absolute and relativ e contra-indications, care and precautions for use; 
VIII - Specification of medical examinations to be carried out before and during use of 
an IUD; 
IX - Reasons for removing an IUD; X - A description of possible interactions  with medications and other forms of 
treatment or investigation, such as radiation therapy or diagnostic procedures; XI - Specification of procedures in the ev ent of pregnancy (intrauterine or ectopic) 
with the IUD in situ and the risks involved in the event of pregnancy with the IUD in 
situ; 
XII - Undesirable effects with frequency and duration of use, incompatibilities; 
XIII - A statement that a medical professi onal must inform the woman about the risks 
and benefits of using an IUD and of the im portance of regular checks for the presence of 
the IUD, and 
XIV - Clinical signs or symptoms which dictate the need to contact a medical 
professional. 
Section VIII 
Information for women 
Article 31. IUDs must be supplied with a printed leaflet containing the following 
information for women, in language whic h is easily understood by a lay person: 
Sole paragraph. The following is the minimu m information to be provided to women: 
I - The model, dimensions and composition of the IUD; II - The mode of action and possibl e effects on the menstrual cycle; 
III: - Contra-indications and special precautions; 
IV - Possible adverse reactions with the concurrent use of medication and possible 
interactions with other treatments; 
V - Insertion and removal procedures; VI - The importance of self–examination to  check that the IUD is in place and the 
procedure for regularly checki ng that the IUD is in place; 
VII - A list of the clinical  signs and symptoms dictati ng the need for the woman to 
seek prompt medical attention; 
VIII - The maximum time the IUD may remain in situ; IX - The name and address of the manuf acturer or importer hol ding the trademark; 
X - The ANVISA / MS registration numb er and the product batch or control 
number. 
CHAPTER III 
REGISTRATION REQUIREMENTS 
Article 32. In order to be regi stered in Brazil, IUDs contai ning copper must comply with 
ANVISA Collegiate Board Resolution No 185 of 22 October 2001 or any measure which 
replaces this. 
Article 33. The safety and effectiveness must  be demonstrated by compliance with the 
requirements of ANVISA Collegiate Board Resolution No 56 of 06 April 2001 or any measure which replaces this, and by submi ssion of an analytical  report issued by the 
INCQS. 
Article 34. In order to demonstrate the minimum clinical performance required, the 
clinical tests conducted in accordance with Standard ISO 14155 must demonstrate a pregnancy rate for the IUD of no more than  2 in 100 women in the first year and an 
expulsion rate of fewer than 10 in  100 women in the first year. 
Article 35.  Clinical trials must last at le ast three years and shoul d investigate at least 
10 000 menstrual cycles, with at least 400 part icipants in the first year and 200 women 
completing the three years of trials with the IUD in situ as attested by records demonstrating that the IUD remained in situ. 
CHAPTER IV 
PRE-REGISTRATION TESTS 
Article 36. The tests provided for in this Regu lation to determine th e length of the IUD, 
diameter of the copper wire, length of the copper wire, length of the wire used to remove 
and check the presence of the IUD, external diameter of the instruments used for insertion, tensile strength, resistance to de formation, concentration of barium sulfate, 
sterility, and concentration of copper must be  conducted for the purposes of registration 
with ANVISA/MS. 
1. The length of the IUD is determined usi ng a steel rule calibrated using the INCQS 
standard operational procedure. 
2. The diameter of the copper wire in the IUD is determined using a calliper in line with 
the INCQS standard op erational procedure. 
3. The length of the copper wire in the IUD is determined using a steel rule calibrated 
using the INCQS standard operational procedure. 
4. The length of the wire used to remove  and check the presence of the IUD is 
determined using a steel rule calibrated usi ng the INCQS standard operational procedure. 
5. The external diameter of insertion instruments is determined using a calliper in line 
with the INCQS standard  operational procedure. 
6. The tensile strength of the IUD is determ ined using a calibrated  mass of 1.2Kg in line 
with the INCQS standard  operational procedure. 
7. The resistance to deformation of the IUD is  determined by simulating the conditions of 
insertion in line with the INCQ S standard operational procedure. 
8. The concentration of barium sulphate is determined in line with the INCQS standard 
operational procedure. 
9. The IUD and the insertion inst ruments must meet the sterility conditions when tested 
in line with the INCQS sta ndard operational procedure. 
10. The concentration of copper in  the wire and other parts is determined in line with the 
INCQS standard operational procedure. 11. The tests must be repeated whenever sign ificant changes are made to processes or 
design or in the event of any other factor with a di rect impact on the product. 
CHAPTER V 
FINAL PROVISIONS 
Article 37. DIMED Resolution No. 6 of 06 July  1984 is hereby repealed, as are any other 
conflicting provisions. 
Article 38. This Resolution shall enter in to force on the date of its publication. 
DIRCEU RAPOSO DE MELLO