Registration of Medical Devices at ANVISA

RDC 185/2001
Technical Regulation Registration, amendment, renewal and cancellation of registration of medical devices in the National Health Surveillance Agency - ANVISA. The provisions of this document are applicable to manufacturers and importers of medical products.

Procedures for Registration

Information to identify the manufacturer or importer and its medical product, declared and signed by the legal guardian and the technical responsible. Information of labels, instructions for use of medical and technical report. Proof of registration or certificate of free trade or equivalent document granted by the competent authority of countries where the medical product is manufactured and / or marketed. All documents must be presented in Portuguese and documents submitted in other languages should be submitted along with the translation.

Copy of authorization from the foreign manufacturer to importer commercialize their medical devices in the country.

Proof of payment of the appropriate health surveillance.

Procedures for Registration

TECHNICAL REPORT
Detailed description of the medical product, including the fundamentals of its operation and its action, its content or composition, when applicable, as well as list of accessories to integrate the product; Statement, purpose or use to which the product is intended the medical device, as indicated by the manufacturer; Precautions, restrictions, warnings, precautions and explanations on the use of medical products, as well as storage and transport;

Procedures for Registration

TECHNICAL REPORT
Forms of presentation of the medical product;

Flow diagram containing the steps of the manufacturing process of medical product with a brief description of each process step, to obtain the finished product;
Description of the efficacy and safety of medical products in accordance with the regulations of ANVISA which provides for Essential Requirements of the Efficacy and Safety of Medical Products. If this description does not prove the efficacy and safety of the product, ANVISA prompt clinical research product.

Procedures for Registration

CHARGES
OPERATION Product Registration * Renewal of Registration * (every 5 years) Inclusion or Change * VALUE ($) 15,000.00 7,500.00 2,000.00

* Including Lawyer, official translation and other expenses.

Particular features of the process

Processes are analyzed by different servers ANVISA, which determines different interpretations of information; High investment by product; Product risk class III and IV must present GMP manufacturer's plant abroad RDC 59/2000, inspected by ANVISA.

* Time for grant of registration: 15 to 18 months;

International inspection of ANVISA

RDC 25/2009
Established how to implement the requirement of GMP certificate for the registration of medical devices at ANVISA. Indispensable for manufacturers of product risk class III and IV.

Procedures for Application

Application form for certification of good practice

Certificate of GMP - GMP or corresponding issued by the health authority in the country of origin Proof of payment of the appropriate health surveillance.

List of Products covered by the international company group and risk class as RDC185/01

Documents required for obtaining the Certificate of Good Manufacturing Practices for Health Products
1 - Cover as art. 4 of the RDC No. 124/04 (unnumbered), if applicable. 2 - Application for a request issued by the company containing the following information: A. Identification of the requesting party (national) - Company name, address and CNPJ; B. Identification of the object of international inspection company Company Name, Address; C. Type of inspection desired; D. Number of authorization of the requesting party (national); E. Activities conducted by the international company, the object of inspection; F. Inform, if any, the outsourced services company in the production process; G. List of Products covered by the international company group and risk class as RDC-185/01 (to be exported to Brazil); H. Name and signature of the Chief Technical Officer and / or Legal. 3 - Original proof of payment of the fee; 4 - Proof of size category of the Company; 5 - Certificate of GMP - GMP or corresponding issued by the health authority in the country of origin - sworn translation and consulate.

International inspection of ANVISA

importers that sell health products, risk class III and IV in Brazil will require plants to international inspection of the factories of its suppliers of products for the same are monitored by ANVISA. Without this certification can no longer apply for registration of products manufactured by the supplier in Brazil, therefore can not sell them.
In 2009, RDC 25/2009 was passed which requires all

International inspection of ANVISA

The revalidation of products already registered will be accepted if the request was filed international inspection of the plant of the factory manufacturing the product. Inspections last about one week.
Generally production and inspection documents are requirement during the inspection.

Particular features of the process

Cost of investment: $ 23,500.00 The revalidation of international certification by ANVISA takes place every 2 or 4 years (according of the risk product classification during the inspection) Time to schedule the inspection after the petitioning : 18 months

Need to be prompted for the inspection units (plants) from manufacturing to produce products that will be registered and sold in Brazil.