Brazil ANVISA Medical Device Regulations
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 |