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Registration of Medical
Devices at ANVISARDC 185/2001Technical Regulation
Registration, amendment, renewaland cancellation of registration ofmedical devices in the National HealthSurveillance Agency - ANVISA.
The provisions of this documentare applicable to manufacturers and
importers of medical products.
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Procedures for Registration
Proof of paymentof the appropriate
healthsurveillance.
Information to identifythe manufacturer orimporter and its medicalproduct, declared andsigned by the legalguardian and the
technical responsible.
Copy of authorizationfrom the foreignmanufacturer to
importer commercializetheir medical devices inthe country.
Proof of registration orcertificate of free tradeor equivalent document
granted by thecompetent authority of
countries where themedical product is
manufactured and / ormarketed.
All documents must bepresented in
Portuguese anddocuments submitted
in otherlanguages should besubmitted along with
the translation.
Information oflabels,instructions foruse of medicaland technicalreport.
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Procedures for RegistrationTECHNICAL REPORT
Detailed description of the medical product,including the fundamentals of its operation and itsaction, its content or composition, whenapplicable, as well as list of accessories tointegrate the product;
Statement, purpose or use to which the productis intended the medical device, as indicated by themanufacturer;
Precautions, restrictions, warnings, precautionsand explanations on the use of medical products,as well as storage and transport;
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Procedures for RegistrationTECHNICAL REPORT
Forms of presentation of the medical product;
Flow diagram containing the steps of themanufacturing process of medical product with a brief
description of each process step, to obtain the finishedproduct;
Description of the efficacy and safety of medicalproducts in accordance with the regulations of ANVISAwhich provides for Essential Requirements of the
Efficacy and Safety of Medical Products. If thisdescription does not prove the efficacy and safety of theproduct, ANVISA prompt clinical research product.
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Procedures for Registration
CHARGES
OPERATION VALUE ($)
Product Registration * 15,000.00
Renewal of Registration *(every 5 years)
7,500.00
Inclusion or Change * 2,000.00
*Including Lawyer, official translation and other expenses.
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Particular features of the processProcesses are analyzed by differentservers ANVISA, which determinesdifferent interpretations of information;
High investment by product;
Product risk class III and IV mustpresent GMP manufacturer's plant abroadRDC 59/2000, inspected by ANVISA.
* Time for grant of registration:15 to 18 months;
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International
inspection of ANVISARDC 25/2009Established how to implement therequirement of GMP certificate for the
registration of medical devices at ANVISA.
Indispensable for manufacturers of
product risk class III and IV.
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Procedures for ApplicationApplication formfor certificationof good practice
Proof of paymentof the appropriate
healthsurveillance.
Certificate of GMP- GMP or
correspondingissued by the
health authority inthe country of
origin
List of Productscovered by theinternational
company group andrisk class as RDC-
185/01
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Documents required for obtaining the
Certificate of Good ManufacturingPractices 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 thefollowing 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 ofinspection;F. Inform, if any, the outsourced services company in the productionprocess;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 healthauthority in the country of origin - sworn translation and consulate.
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In 2009, RDC 25/2009 was passed which requires allimporters that sell health products, risk class III and IV in
Brazil will require plants to international inspection of thefactories of its suppliers of products for the same aremonitored by ANVISA.
Without this certification can no longer apply for
registration of products manufactured by thesupplier in Brazil, therefore can not sell them.
Internationalinspection of ANVISA
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International inspection
of ANVISA
The revalidation of products already registered will beaccepted if the request was filed international inspection ofthe plant of the factory manufacturing the product.
Inspections last about one week.
Generally production and inspection documents are
requirement during the inspection.
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Particular features of the process
Cost of investment: $ 23,500.00
The revalidation of internationalcertification by ANVISA takes place every 2or 4 years (according of the risk productclassification during the inspection)
Time to schedule the inspection after thepetitioning : 18 months
Need to be prompted for the inspectionunits (plants) from manufacturing toproduce products that will be registered andsold in Brazil.
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