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Brazilian Sanitary Surveillance Agency ANVISA

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Laying down instructions on the registration, manufacture, quality control, marketing and use of copper bearing intrauterine devices (IUDs).

Brazilian Sanitary Surveillance Agency (ANVISA)

    www.anvisa.gov.br

    Public Consultation No 78, 13 November 2006

    Diário Oficial da União (Brazilian Official Journal) of 17.11.2006

    The Board of the National Health Surveillance Agency, in the exercise of the powers granted by Item IV of Article 11 and Article 35 of ANVISA’s Regulations, approved by Decree No. 3029 of 16 April 1999, and having regard to the provisions of Item V and points 1 and 3 of Article 54 of the Internal Regulations approved in accordance with Appendix I of ANVISA Administrative Ruling No. 354 of 11 August 2006, republished in the DOU of 21 August 2006, at a meeting held on 6 November 2006,

    hereby adopts the following Public Consultation, and I, the Director-President, order its publication:

    Article 1 - A period of sixty days from the date of publication of this Public Consultation is hereby declared open for presenting criticism and suggestions concerning the proposed Technical Regulation for the registration, manufacture, quality control and information for users of copper bearing intrauterine devices (IUDs), in the Annex.

    Art. 2. The full proposal will be available, during the consultation period, at the following web site http://www.anvisa.gov.br, and suggestions should be sent in writing to the following address: Agência Nacional de Vigilância Sanitária, Gerência-Geral de Tecnologia de Produtos para Saúde, SEPN 515, Bloco B, Ed. Ômega, Asa Norte, Brasília, DF, CEP 70.770-502 or Fax: (061) 3448 -1058 e-mail: tecnologia.produtos@anvisa.gov.br.

    Art. 3. At the end of the period specified in Art. 1, the National Sanitary Surveillance Agency will talk to the Bodies and Entities involved and other parties with an interest in the matter, and ask them to nominate representatives for subsequent discussions in order to arrive at a final wording.

    DIRCEU RAPOSO DE MELLO

    ANNEX

    RESOLUTION OF THE COLLEGIATE DIRECTORATE NO … OF … … 2006

    Laying down instructions on the registration, manufacture, quality control, marketing and use of copper bearing intrauterine devices (IUDs).

    The Collegiate Directorate of the National Health Surveillance Agency, pursuant to the powers conferred on it by Article 11(IV) of the ANVISA Regulation approved by Decree No 3029 of 16 April 1999 and Article 111(I)(b) of the Internal Regulation approved by Order No 593 of 25 August 2000 published in the Official Journal of Brazil of 22 December 2000, meeting on 5 June 2006,

    Given the need to update the instructions on registration, manufacture, quality control, marketing and use of copper bearing intrauterine devices (IUDs);

    Considering the requirements to be met by enterprises in applying for registration; Has adopted the following Collegiate Board Resolution and I, the Director-President, order its publication:

    Article 1? The Technical Regulation attached to this Resolution on the registration, manufacture, quality control, marketing and use of copper bearing intrauterine devices (IUDs) is hereby approved.

    Article 2. DIMED Resolution No. 6 of 6 July 1984 is hereby repealed.

    Article 3 This Resolution shall enter into force on the date of its publication. DIRCEU RAPOSO DE MELLO

ANNEX

    TECHNICAL REGULATION ON REGISTRATION, MANUFACTURE, QUALITY

    CONTROL AND INFORMATION FOR USERS OF COPPER BEARING

    INTRAUTERINE DEVICES (IUDS)

    PART 1. OBJECTIVE

    1.1 This regulation lays down instructions on the registration, manufacture, quality control,

    marketing and use of copper bearing intrauterine devices (IUDs).

    PART 2. DEFINITIONS

    2.1 Adoption of the definitions of ISO 7439. PART 3 REFERENCE STANDARDS 3.1 Resolution RDC No 185 of 22 October 2001, registration, alteration, revalidation and cancellation of the registration of medical products.

    3.2 ISO 7439 Copper bearing intra-uterine contraceptive devices Requirements, tests

    3.3 ISO 14155 Clinical investigation of medical devices for human subjects. 3.4 Resolution RDC No 56 of 6 April 2001, Resolution RDC No 56 of 6 April 2001, essential safety and effectiveness requirements for health products

    PART 4 - GENERAL REQUIREMENTS

    4.1.Format

    a) When examined by visual inspection and by touch, IUDs should be shaped to adapt to the uterine cavity and to minimise the risk of perforation.

    b) Neither IUDs or insertion instruments should have sharp points.

    c) IUDs which require an insertion instrument for correct application must be supplied with this.

    4.2 - Dimensions

    4.2.1 - IUD

    a) The nominal length of an IUD should not exceed 36mm, and the nominal width should not exceed 32mm.

    b) When determined in accordance with item 10.1, the dimensions should be consistent with the specifications laid down by the manufacturer with a tolerance of +/- 5%.

    4.2.2 Copper components

    a) The area of the nominal active copper surface should be 200mm2 or more and no more than 380 mm2.

    b) Any copper wire used must have a diameter of at least 0.25mm.

    c) 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% when determined in accordance with item 10.2.

    d) The area of the copper surface should be calculated on the basis of the measurements of the diameter and length of the copper wire as laid down in items 10.2 and 10.3. 4.2.3 Wire

    a) When determined as laid down at 10.4, the length of wire connected to the underside of the plastic body must be at least 100mm.

    4.2.4 Insertion instruments a) The external diameter of any part of an insertion instrument intended to come into contact with the cervical canal should be no more than 5mm when determined in accordance with item 10.5. 4.3 - Tensile strength,

    a) When determined as at 10.6, the IUD, including any wire, should withstand a tensile force of at least 12N.

4.4.- Stability

    4.4.1 Shelf life

    a) IUDs should maintain all the characteristics declared by manufacturers for the entire period of validity laid down if the storage conditions laid down by the manufacturer are met. 4.4.2 Stability in situ

    a) IUDs, including their copper components, should maintain their structural integrity for the whole period of use declared by their manufacturers.

    b) Within the period laid down for use, on removal, IUDs should meet the specifications of item 4.3.

    4.5 Resistance to deformation

    a) IUDs must regain their original form when tested as laid down at 10.7.

    b) Residual deformation must be no more than 5mm.

    4.6 Detection in situ

    a) All parts of IUDs must be detectable by radiological examination (X Ray).

    b) When barium sulphate is used to make the plastic components radio-opaque,

    the concentration must be between 15% (p/p) and 20% (p/p), determined as laid down at 10.8. 4.7.- Sterility

    b) IUDs and insertion instruments must be supplied in sterile conditions, as proved when tested as laid down at 10.9.

    PART 5. MATERIALS

    5.1 The plastic body of the IUDs should be viscoelastic (see item 4.5), biocompatible and

    nonabsorbable.

    5.2 Any wire should be biocompatible and nonabsorbable. 5.3 Copper used should be at least 99.9% pure, determined as laid down at 10.10. PART 6. LABELLING

    6.1 The labelling for the marketing and use of IUDs should meet the requirements of Resolution ANVISA RDC No 185 of 22 October 2001 or any measure which replaces it.

    PART 7 INSTRUCTIONS FOR USE 7.1 IUDs must be supplied with instructions for use which comply with Resolution ANVISA

    RDC No 185 of 22 October 2001 or any measure which replaces this, and must also provide the following information for the medical profession:

    a) international generic name;

    b) a description of the model, with dimensions and composition;

    c) a description of the intended use;

    d) the recommended time for insertion after an abortion, childbirth or coitus;

    e) a description of the insertion procedure with illustrations.

    f) the maximum time the IUD may remain in the insertion instrument;

    g) the maximum time the IUD may remain in situ;

    h) a description of the removal procedure and steps to take in the event of difficulties during removal;

    i) absolute and relative contra-indications;

    j) care and precautions for use and the specification of medical examinations to be carried out before and during use of IUDs;

    k) reasons for removing the IUD;

    l) a description of possible interactions with medications and other forms of treatment or investigation, such as radiation therapy or diagnostic procedures.

m) specification of procedures in the event of pregnancy (intrauterine or ectopic) with the IUD in

    situ;

    n) the risks involved in the event of pregnancy with the IUD in situ;

    o) undesirable effects with frequency and duration of use;

    p) incompatibilities;

    q) a statement that a medical professional must inform the woman about the risks and benefits of

    using an IUD and of the importance of regular checks for the presence of the IUD and the clinical

    signs or symptoms which dictate the need to contact a medical professional.

    PART 8 INFORMATION FOR THE WOMAN 8.1 IUDs must be supplied with a printed leaflet containing the following information aimed at women, at least, in language which is easily understood by a lay person:

    a) the model, dimensions and composition of the IUD;

    b) the mode of action and possible effects on the menstrual cycle;

    i) contra-indications and special precautions;

    d) possible adverse reactions with the concurrent use of medications;

    e) possible interactions with other treatments;

    f) insertion and removal procedures;

    g) the importance of selfexamination to check that the IUD is in place;

    h) the procedure for regularly checking that the IUD is in place;

    i) a list of the signs and clinical symptoms dictating the need for the woman to seek prompt

    medical attention;

    j) the maximum time the IUD may remain in situ;

    k) the name and address of the manufacturer or importer holding the trademark;

    l) the ANVISA / MS registration number;

    m) the product batch or control number.

    PART 9 REGISTRATION REQUIREMENTS 9.1 To be registered in Brazil, copper bearing intrauterine devices (IUDs) must meet the requirements of Resolution ANVISA RDC No 185 of 22 October 2001 or any measure which

    replaces it.

    9.2 The proof of safety and effectiveness must meet the requirements laid down in Resolution ANVISA RDC No 56 of 06 April 2001, or any measure which replaces this. and must be

    accompanied by an analytical report issued by the INCQS.

    9.3 Minimum clinical performance required

    a) The clinical tests carried out as laid down in ISO 14155 must demonstrate that the IUD meets

    the following requirements:

    (i) a pregnancy rate of no more than 2 in 100 women in the first year, and

    (ii) an expulsion rate of fewer than 10 in 100 women in the first year.

    b) The clinical trials should last at least three years and should investigate at least 10 000

    menstrual cycles, with at least 400 participants during the first year and 200 women completing

    the three-year test with the IUD in situ, as attested by records proving that the IUD remained in

    situ.

PART 10. TESTS

    10.1 Determination of length

    a) The length of IUDs is determined using a steel rule calibrated using the INCQS standard operational procedure.

    10.2 Determination of the diameter of the copper wire a) The diameter of the copper wire in IUDs is determined using a calliper in line with the INCQS standard operational procedure.

    10.3 Determination of the length of the copper wire a) The length of the copper wire in IUDs should be determined using a steel rule calibrated in line with the INCQS standard operational procedure.

    10.4 Determination of the length of wire for removal and checking that it is in place

    a) The length of the wire should be determined for removal and checking that it is in place using a steel ruler calibrated in line with the INCQS standard operational procedure. 10.5 Determination of the external diameter of insertion instruments a) The external diameter of insertion instruments is determined using a calliper in line with the INCQS standard operational procedure.

    10.6 - Tensile strength,

    a) The tensile strength of IUDs is determined using a calibrated mass of 1.2 Kg in line with the INCQS standard operational procedure.

    10.7 Resistance to deformation

    a) The resistance to deformation of IUDs is determined by simulating the conditions of insertion in line with the INCQS standard operational procedure.

    10.8 Determination of the concentration of barium sulphate a) The concentration of barium sulphate is determined in line with the INCQS standard operational procedure.

    10.9.- Sterility

    a) The IUD and the insertion instruments must meet the sterility conditions when tested in line with the INCQS standard operational procedure.

    10.10 Determination of the concentration of copper a) The concentration of copper in the wire and other parts is determined in line with the INCQS standard operational procedure.

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