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Brazilian Market – INMETRO An Overview and the better solutions for INMETRO certification process

MEDICAL DEVICES – CERTIFICATION PROCESS

External Webinar | Andréa Aparecida de Souza | 09/11/2020 (Version 1)

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Guest speaker

Andréa Aparecida de SouzaTeam Leader – Medical Devices

SGS

andrea.desouza.external@sgs.com

Andrea is electronical technician, graduated as Physicist and

have got MBA in Engineer & Management of Quality. Also had

been working during 13 year doing safety/electrical evaluation

in an important Brazilian laboratory (IPT).

Andrea Souza has more than 12 years experience in

certification process according to Brazilian rules for active

Medical Devices. Since 2009 she´s working at SGS, and

currently she is leading the SGS Brazilian team, supporting all

technical aspects in certification process of Medical devices.

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Agenda 01 INMETRO process - Overview02 INMETRO - Current regulation

03 INMETRO – process in 3 steps

04 Questions

© SGS Société Générale de Surveillance SA –

2020 – All rights reserved - SGS is a registered

trademark of SGS Société Générale de

Surveillance SA

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INMETRO – Orverview

▪ Main stakeholders

• ANVISA - The National Health

Surveillance Agency

• INMETRO - National Institute of

Metrology, Standardization and Industrial

Quality

• OCP - Organization of Certification of

product (SGS!)

• Importer (Brazilian Representative)

It is essential know these stakeholders!

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INMETRO – Orverview (cont.)SGS Group can offer all

support on the activities

needed to get the

INMETRO certificate!

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INMETRO – Current Regulation

▪ ORD Nr. 54 + ORD 544 (+ ORD118) (issued

by INMETRO)

• It defines the entire procedure with the main

requirements of the product certification

process.

▪ Resolution RDC 27 (issued by ANVISA)

• Complementary for the product certification

process.

▪ Normative Instruction IN: Nr 49 (issued by

ANVISA)

• All standards required in the process are listed

here.

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INMETRO – Current Regulation(cont.)

▪ ORD Nr. 111 (issued by INMETRO)

• It defined complementary rules due the

pandemic situation (expired).

▪ ORD Nr. 225 (issued by INMETRO)

• It defines complementary rules due the

pandemic situation.

“ INMETRO: NEW MODEL OF REGULATION”

No news on this subject, but SGS team is always

monitoring to provide any important updating, if any.

Rules issued due the Pandemic situation!

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INMETRO Process – 3 steps

• 1st step: Send the application form filled out, plus the user manual of the product: mainly, this form requires information related to Manufacturer/Applicant, Brazilian Representative etc. In case of any doubt you can account with our support for clarifications.

Step 1

• 2nd step – It is mandatory that We get a contract with the Brazilian Representative mentioned on the application form, before starts the process.

Step 2

• 3rd step – We are ready to starts! And then the applicant/manufacturer must send all documentation listed in our checklist of documents! This documents must be collected by SGS Affiliates or sent directly by the Manufacturer/Importer to SGS Brazil. The communication with the manufacturer will be done by the affiliates, only when the project was sold by Affiliate. Only SGS Brazil approve and issue the certificate.

Step 3

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INMETRO Process – Turn Around Time - 10 Workdays!

1st Technical

Analysis

TECHNICAL ANALYSIS of

the package of documents

must be done in 05 WD

3rd DRAFT of the

certificate is sent to the customer´s approval 01

WD.

2nd Technical

review/Approval

The TECHNICAL REVIEW

must conclude it in 04WD

Important

It´s mandatory send the

complete package to

consider this TAT. And if

the package is rejected

the time restarts.

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Questions?Emailto:

andrea.desouza.external@sgs.com

© SGS Société Générale de Surveillance SA – 2020 – All rights reserved -

SGS is a registered trademark of SGS Société Générale de Surveillance SA

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The INMETRO process is not

monster, only a bit complex on

the rules, and heavy on the

amount of documentation

evaluated. But you need only

high-energy and SGS!

Andrea Aparecida de Souza

MD team leader

SGS

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Thank you!Do you have any additional questions?

andrea.desouza.external@sgs.com

+55 11 95654 2080

www.sgs.com

© SGS Société Générale de Surveillance SA – 2020 – All rights reserved -

SGS is a registered trademark of SGS Société Générale de Surveillance SA

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