Brazil ANVISA Medical Device Regulations
All documents listed below were published by ANVISA in Portuguese and translated by Emergo into English. Use the English for informational purposes only.
Major Regulations
| Document | Language | Number | Published |
|---|---|---|---|
| Classification and Registration Requirements of Medical Products | en pt | RDC 185/2001 | 2001 |
| GMP Requirements for Medical Devices and IVDs | en pt | RDC 16/2013 | 03/2013 |
| Requirements for Economic Information Report (EN) | en pt | RDC 185/2006 | 2006 |
| Requirements for Proof of GMP for registration processes of healthcare products (EN) | en pt | RDC 15/2014 | 2014 |
General Guidance Documents
| Document | Language | Number | Published |
|---|---|---|---|
| Administrative Procedures for GMP | en pt | RDC 39/2013 | 2013 |
| Changes Law 9782-1999 GMP | en pt | LEI 11.972/2009 | 2009 |
| Consumer Protection Code | en pt | LEI 8.078/1990 | 1990 |
| DECRETO - Health Surveillance | en pt | 8077/2013 | 2013 |
| Health Surveillance Standards | en pt | LEI 6.360/1976 | 1976 |
| Mandatory Certification of Equipment | en pt | RDC 27/2011 | 2011 |
| Safety and Efficacy Requirements | en pt | RDC 56/2001 | 2001 |
| Sanitary Violations and Sanctions | en pt | LEI 6.437/1977 | 1977 |
Specific Guidance Documents
| Document | Language | Number | Published |
|---|---|---|---|
| List of Products Requiring Economic Information Report | en pt | RE 3385/2006 | 2006 |
| Cadastro Registration Requirements of Medical Devices | en pt | RDC 40/2015 | 08/2015 |
| Cadastro registration of IVDs | en pt | RDC 36/2015 | 27 August 2015 |
| Changes RDC 206/2006 regarding IVDs | en pt | RDC 34/2012 | 2012 |
| General Requirements for Product Certification | en pt | 118/2016 | 03/2016 |
| Import of Products for Fairs and Events | en pt | RDC 13/2004 | 2004 |
| Inmetro Certification - Registrations issued After 1 February 2016 | en pt | 54/2016 | 02/2016 |
| Inmetro Certification - Registrations issued prior to 31 January 2016 | en pt | 350/2010 | 2010 |
| Labeling information for devices with natural rubber latex components | en pt | RDC 37/2015 | 27 August 2015 |
| List of GMP Provisions for Importers Distributors and Storage Companies (EN) | en pt | IN 08/2013 | 2013 |
| List of Products Prohibited to be Reprocessed | en | RE 2605/2006 | 2006 |
| On registration of IVD families | en pt | IN 03/2015 | 26 August 2015 |
| Requirements for Electronic IFU | en pt | IN 04/2012 | 2012 |
| Technovigilance Requirements for Registration Holders | en pt | RDC 67/2009 | 2009 |
| Transfer regulation | en | RDC 102/2016 | 08/2016 |
| Used and Refurbished Products | en pt | RDC 25/2001 | 2001 |
Additional Information
| Document | Language | Number | Published |
|---|---|---|---|
| Chronological Criteria for Registration Application Reviews | en pt | RDC 3/2010 | 2010 |
| Field Action Requirements | en pt | RDC 23/2012 | 2012 |
| List of Products Not Deemed as Healthcare Products | en pt | Version 5 | 08/2016 |
| National Sanitary Surveillance System and National Health Surveillance Agency Creation | pt | LEI 9782/1999 | 1999 |
| Technical Note - Concept of Legal Manufacturer | en pt | 001/2009 | 05/2009 |
| Technical Note - GGTPS Submission of GMP Application | en pt | 002/2009 | 2009 |
| Technical Note 004/2016 - Clinical Trial Requirements and Guidelines for Registro and Cadastro products | en pt | 004/2016 | 11/2016 |