Relevant Regulatory Harmonization Initiatives
International Medical Device Regulators Forum (IMDRF); MERCOSUR, Medical Device Single Audit Program (MDSAP).
Clinical Trial Data Requirements
First, the study documentation must be translated into Portuguese (2-4 weeks). The clinical trial protocol must be approved by the institutional IRC, CONEP (if the trial is foreign sponsored), and ANVISA. ANVISA is responsible for issuing the Special Communicate (trial approval document), and import license. Documents required in the dossier are listed in Annex I of Rules for the Conduct of Clinical Research (RDC 39, June 5, 2008).
Clinical Trial Import Authorization
Importing products requires an import license. The form to request a license to import a product for a study is available in Annex III of the Rules for the Conduct of Clinical Research (RDC 39, June 5, 2008).
Clinical Trial Estimated Timeline
According to "Clinical Trials in Brazil: Facing the Challenges"
Documentation translation: 2–4 weeks
CEP/IRC approval: 2–8 weeks
CONEP approval: 8–12 weeks
ANVISA approval (Special Communicate Issue): 4–8 weeks
ANVISA—License importation: 2–4 weeks
Total: 18–35 weeks
Clinical Trial Costs
Documentation translation: $3000-$6000 (informed consent form, investigator brochure, protocol translation)
CEP/IRC approval: No fee-$1200 (Sometimes CEP/IRCs charge an administrative fee of $250-$1200)
CONEP approval: No fee
ANVISA approval (Special Communicate) $6000 (expires after 6 months from the first site inclusion. $6000 fee is assessed after each new inclusion)
ANVISA—License importation 2–4 weeks: No fee
In-Country Manufacturing Requirements
Brazil follows Good Manufacturing Practices (GMP).
ANVISA follows the Pan American Health Organization's Good Clinical Practices. Sponsors are required to have insurance. A copy of the Good Clinical Practices is available here.
Sponsors are required to cover the costs of treatment for trial subjects in the event of an injury.
Product Registration Estimated Timeline
According to EMERGO Group, getting a Class I or II low-risk device application approved will take approximately 6-10 months and 8-12 months for full registration. Class III or IV devices must also submit a Brazilian GMP certificate, which can increase the approval time up to 4 years due to backlog.
Precedent (Clinical Trials Approved/Denied in Last 2 Years)
48 clinical trials approved from June 2012 - July 2014.
Product Registration Data Requirements
The primary legal document guiding medical device regulation is Resolution no. 185/01.
Any medical device imported into or distributed in Brazil must be registered with ANVISA. The applying company must be based in Brazil. A Brazilian-based third party may apply on behalf of a foreign company. Criteria for medical device classification is listed in Annex I of Resolution no. 185/01. The class of the device may have an impact on requirements for registration with ANVISA. Basic requirements include:
1. Free sales certificate.
2. Certificate of Good Manufacturing Practices (GMP).
3. Instruction manual in Portuguese.
4. Labelling and pacakaging.
5. Letter from the device manufacturer which authorizes a Brazilian company to register and distribute the device.
6. Clinical trials.
7. List of all device accessories.
8. Economic Information Report for some devices.
9. INMETRO certificate.
In March 2014, ANVISA passed Resolution no. 15/2014, which creates an expedited pathway for Class III and IV medical devices. Under the resolution, ANVSIA will preliminarily evaluate a device before a manufacturing site is granted a Certificate of Good Manufacturing Practices (CBPF). The resolution also removes the requirement for lower risk devices, like syringes, to receive CBPF prior to importation. A copy of this resolution is currently unavailable. More information is available here.
Product Registration Costs
Charts of cost are available in the appendices here (in Portuguese).
Post Registration Labeling Requirements
Resolution no. 21/2012 outlines requirements for drug labelling. The resolution is available here (in Portuguese).
Post Registration Pharmacovigilance Requirements
Pharmacovigilance requirements (including timelines) are listed here. The expected frequency for filing PPRs is dependent on the time elapsed since authorization is granted. Health surveillance requirements (both pre- and post-registration) are outlined in Decree 8077/2013.
November 18, 2014.