© 2014 Emergo Group Inc.

NOTE: Some devices listed in RDC 3385/2006 require an Economic Information Report (EIR) compliant with RDC 185/2006 be submitted to NUREM, a division of ANVISA, with the application or within 30 days after its approval. This report includes pricing comparisons for other markets, patient/user information, and marketing materials.

* Devices listed in IN 9/2013. This includes many electro-medical devices, and some non-electrical products such as: breast implants, sterile hypodermic syringes, sterile needles, gloves, condoms, mattresses, blood bags, intrauterine devices, protective glasses (laser).

** Third edition of IEC 60601 testing is mandatory. All tests performed outside of Brazil must be less than two years old when they are submitted to INMETRO Certifier.

*** Per RDC 15 of 28 March 2014, the Class I and II products which are listed on the IN 2/2011 exception list are still classified as registro but no longer require BGMP and do not need to pay BGMP fees.

This is a simplified overview of the process. ANVISA may choose to audit your submission and request more documents, which will add time to your approval.

© 2014 Emergo Group – You are welcome to publish this chart on your website, or copy it for use in presentations or other materials if it is not cropped in any way. Have comments or suggestions about the content of this chart? Email us at marketing@emergogroup.com. Chart updated 07/2014.

5041-0714

Learn more about Brazil:

EmergoGroup.com/brazil

BRAZILThe medical device regulatory approval process

Determine classification of your device using rules found in Annex II of Brazilian Resolution RDC 185/2001 published by the Agência Nacional de Vigilância Sanitária (ANVISA).There are two registration routes: Cadastro and Registro. Cadastro is for lower risk devices, has a simplified application, and typically takes less time than registro reviews.

Class I and IICadastro

Class I and IIRegistro

Class IIIRegistro

Class IVRegistro

Appoint a company that holds a Company Working Allowance permit from ANVISA as your Brazil Registration Holder (BRH).

Certain devices* require INMETRO Certification. Testing for electro-medical products performed outside Brazil is usually accepted if performed by an ILAC-certified lab.** (CB Scheme is not accepted).** Compile tests and pay fee to INMETRO Certifier. INMETRO certification is valid for 5 years, and annual audits and fees are required.

Class I and II device manufacturers must comply with BGMP requirements.ANVISA will not conduct an audit.***

Class III and IV manufacturers must be audited for BGMP compliance by ANVISA as found in RDC 16/2013. BGMP fees due every two years.

Prepare abbreviated application. Send legal documents, as well as proposed

labeling and IFU to BRH to keep on file in case of later ANVISA audit.

Prepare Technical File which includes clinical data, clinical studies (if applicable), information on your device in accordance with Annex III, Part A, B, and C in RDC 185/2001, as well as proposed labeling and instructions for use found in Annex III Part B.

Obtain Certificate of Free Sale (CFS) or device registration certificate proving home-country approval from your Ministry of Health. – OR – Show proof of registration in two other markets and provide reason your device does not have home-country approval. – OR –

INMETRO certificate for applicable devices.

Provide Letter of Authorization to your BRH, who will submit your registration application and Technical File to ANVISA. Your BRH maintains control of your device registration and Brazil Good Manufacturing Practice (BGMP) certification (if applicable).

Appoint a qualified importer/distributor to bring your device into Brazil. You may now begin marketing your device.

ANVISA reviews registration application. If approved, ANVISA will publish registration number in the Diário Oficial da União (DOU). Registrations are valid for 5 years. Registration renewals must be initiated one year prior to expiration.

BRH submits abbreviated application to ANVISA. Documents must be submitted in Brazilian Portuguese. Pay application fee.

Your BRH submits full application, which includes the technical file, to ANVISA. All documents must be submitted in Brazilian Portuguese. Pay application fee.

© 2014 Emergo Group Inc.

NOTE 1: The time frames shown above are typical for the majority of medical device submissions but assume that your device does not contain animal tissue, medicinal substances or employ entirely novel technology. Your length of approval will depend on the quality and completeness of your technical documentation and how much time you take to address additional information requests from authorities after submission. YOUR SUBMISSION(S) MAY TAKE MORE TIME THAN WHAT IS SHOWN ABOVE.

NOTE 2: Registrations remain valid for the time specified as long as you do not make changes. Any changes to the device, new model, intended use or indications for use, change in manufacturing location, or other changes, will require a modification of your registration and review by ANVISA.

NOTE 3: We recommend starting the re-registration process no later than the time period specified above as the renewal process in Brazil requires a lengthy review time. To avoid any lapse in your device registration we recommend renewal paperwork be submitted to ANVISA as early as permitted, which is one year prior to the expiration of your current registration; our experience indicates the full year may be required for review. Prior to the date of submission please allow sufficient time to prepare the renewal documents. However, these are only guidelines. Please consult with your distributor or regulatory expert well before this suggested time to avoid any lapse in your registration.

NOTE 4: Our rating of the complexity of the registration process is based on our experience and the opinion of nearly 1,000 QA/RA professionals worldwide who were asked to rate the difficulty of registering a device in each country in January 2014. The European CE Marking process is considered the mid-point to which all other markets are compared.

NOTE 5: Low = Less than US$5000; Midpoint = US$15000-$30000: High = More than US$50000. Overall cost includes registration application fees, product testing, in-country representation, submission preparation consulting and translation of registration documents but not IFU. Costs assume you already have approval for your device in the United States, Europe, Canada or Japan. Does not include cost of implementing, auditing, or updating a quality management system compliant with BGMP, ISO 13485 or US FDA 21 CFR Part 820, if applicable.

* These abbreviated review times apply to Class I and II devices NOT listed in IN 2/2011.

** These review times apply to Class III and IV devices. However, in order to qualify for these abbreviated review times, you must: 1) file a lawsuit against ANVISA to force a Brazil Good Manufacturing Practice (BGMP) inspection within 6-8 months, or 2) appoint a Brazil Registration Holder that is a member of ABIMED (Emergo Group is a member) and your company must already have ISO 13485 certification or other internationally accepted GMP certificate. Existing ISO 13485 certificates may suffice as temporary proof of QMS compliance if submitting through an ABIMED member, such as Emergo Group. Companies must still schedule and pass a BGMP audit by ANVISA while the registration may proceed in parallel, and ANVISA reserves the right to revoke certification at any time in case of noncompliance. Ask us for more details.

*** These review times apply to all Class III and IV devices assuming: 1) your Brazil Registration Holder is NOT a member of ABIMED and 2) you are NOT suing ANVISA to expedite a Brazil Good Manufacturing Practice (BGMP) inspection by ANVISA. The primary reason review times are so much longer is that ANVISA requires all Class III and IV devices to comply with, and be audited for, BGMP. Only after the audit has been completed and a BGMP certificate has been received will ANVISA provide their decision on the application. In total, this process can take 5 years or longer. Ask us for more details.

© 2014 Emergo Group – You are welcome to publish this chart on your website, or copy it for use in presentations or other materials if it is not cropped in any way. Have comments or suggestions about the content of this chart? Email us at marketing@emergogroup.com. Chart updated 07/2014.

Learn more about Brazil:

EmergoGroup.com/brazil

BRAZILDevice classification

in Brazil

How long you should expect to wait after

submission until approval is granted.

(See note 1)

Validity period for device registrations.

(See note 2)

Registration renewal should be started

this far in advance.(See note 3)

Complexity of the registration process for

this classification.(See note 4)

Overall cost of gaining regulatory approval.

(See note 5)

CLASS I and II — CadastroNOT listed on IN 2/2011*

5-10 months 5 years 1.5 yearsSimple Complex Low High

CLASS I and II — Registro Listed on IN 2/2011

10-20 months 5 years 1.5 yearsSimple Complex Low High

CLASS III — Registro ABIMED route**

18-30 months 5 years 1.5 yearsSimple Complex Low High

CLASS III — Registro Traditional route***

5 years+ 5 years 1.5 yearsSimple Complex Low High

CLASS IV — Registro ABIMED route**

18-30 months 5 years 1.5 yearsSimple Complex Low High

CLASS IV — Registro Traditional route***

5 years+ 5 years 1.5 yearsSimple Complex Low High