Apresentação registro e cert internacional

7/30/2019 Apresentao registro e cert internacional

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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.

Apresentação registro e cert internacional

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