Postmarket Requirements for Medical Devices: A Practical Guide
iv
Section IV: Latin America (LATAM).............................................................................................................241
Chapter 14 Postmarket Compliance: Argentina and Chile................................................................. 243
By Sharon Perez, PhD
Chapter 15 Postmarket Compliance: Brazil, Colombia, Mexico, and Venezuela. ...............................255
By Sharon Perez, PhD
Chapter 16 Postmarket Surveillance: Argentina and Chile................................................................. 279
By Julia Stindl, PhD and Sharon Perez, PhD
Chapter 17 Postmarket Surveillance: Brazil, Colombia, Mexico, and Venezuela. ...............................291
By Julia Stindl, PhD and Sharon Perez, PhD
Section V: A Global Perspective on Cybersecurity. .............................................................................313
Chapter 18 Postmarket Cybersecurity Expectations. ..........................................................................315
By Michelle Jump, MSc, RAC
Tables
Table 1-1. Definitions of Establishment Activities. ..............................................................................7
Table 2-1. Domestic Establishments................................................................................................... 26
Table 2-2. Foreign Establishments .....................................................................................................27
Table 2-3. Mandatory Reporting Requirements. ................................................................................35
Table 2-4. Types of FDA Recalls .......................................................................................................37
Table 3-1. Changes to Class III and IV Medical Devices................................................................... 50
Table 3-2. License Amendment Application Timelines in Calendar Days......................................... 55
Table 4-1. Shortage Reporting Timelines. ..........................................................................................66
Table 5-1. Reporting Timeframes for Incidents in Canada................................................................. 77
Table 6-1. Examples of Significant and Nonsignificant Changes Under the EU IVDR. .................104
Table 7-1. Contact Information for All National Competent Authorities........................................ 112
Table 7-2. Types of Data Required for PSUR................................................................................... 118
Table 8-1. Types of Data for Postmarket Surveillance. .....................................................................129
Table 8-2. Incident Reporting Timelines. .........................................................................................132
Table 8-3. PMSR/PSUR Reporting Frequency Under the EU MDR32 and EU IVDR. .................133
Table 12-1. Domestic Device Malfunction “Near Incident” Reports (Event had the Potential to
Cause Health Damage) ...................................................................................................195
Table 12-2. Domestic Adverse Event Reports (Event Resulted in Health Damage).......................... 195
Table 12-3. Foreign Device Malfunction “Near Incident” Reports (Event had the Potential to
Cause Health Damage).................................................................................................... 195
Table 12-4. Foreign Adverse Event Reports (Event Resulted in Health Damage). ............................195
Table 13-1. Timeframe for Reporting an MDAE in India................................................................. 235
Table 14-1. Pecuniary Sanctions. ........................................................................................................246
Table 15-1. Pecuniary Sanctions ........................................................................................................259
Table 15-2. Notification Times for Periodic Reports .........................................................................269
Table 18-1. Excerpt from the Essential Performance Tables That Map to Standards. ........................321
Table 18-2. Australian TGA Recall Actions Related to Cybersecurity ..............................................332
Figures
Figure 2-1. Lifecycle of a Medical Device. ...........................................................................................24
Figure 2-2. Annual Registration Process. .............................................................................................28
Figure 2-3. FD&C Section 522 Postmarket Surveillance Process .......................................................30
Figure 2-4. How Postmarket Reports are Sent to FDA. ......................................................................36
iv
Section IV: Latin America (LATAM).............................................................................................................241
Chapter 14 Postmarket Compliance: Argentina and Chile................................................................. 243
By Sharon Perez, PhD
Chapter 15 Postmarket Compliance: Brazil, Colombia, Mexico, and Venezuela. ...............................255
By Sharon Perez, PhD
Chapter 16 Postmarket Surveillance: Argentina and Chile................................................................. 279
By Julia Stindl, PhD and Sharon Perez, PhD
Chapter 17 Postmarket Surveillance: Brazil, Colombia, Mexico, and Venezuela. ...............................291
By Julia Stindl, PhD and Sharon Perez, PhD
Section V: A Global Perspective on Cybersecurity. .............................................................................313
Chapter 18 Postmarket Cybersecurity Expectations. ..........................................................................315
By Michelle Jump, MSc, RAC
Tables
Table 1-1. Definitions of Establishment Activities. ..............................................................................7
Table 2-1. Domestic Establishments................................................................................................... 26
Table 2-2. Foreign Establishments .....................................................................................................27
Table 2-3. Mandatory Reporting Requirements. ................................................................................35
Table 2-4. Types of FDA Recalls .......................................................................................................37
Table 3-1. Changes to Class III and IV Medical Devices................................................................... 50
Table 3-2. License Amendment Application Timelines in Calendar Days......................................... 55
Table 4-1. Shortage Reporting Timelines. ..........................................................................................66
Table 5-1. Reporting Timeframes for Incidents in Canada................................................................. 77
Table 6-1. Examples of Significant and Nonsignificant Changes Under the EU IVDR. .................104
Table 7-1. Contact Information for All National Competent Authorities........................................ 112
Table 7-2. Types of Data Required for PSUR................................................................................... 118
Table 8-1. Types of Data for Postmarket Surveillance. .....................................................................129
Table 8-2. Incident Reporting Timelines. .........................................................................................132
Table 8-3. PMSR/PSUR Reporting Frequency Under the EU MDR32 and EU IVDR. .................133
Table 12-1. Domestic Device Malfunction “Near Incident” Reports (Event had the Potential to
Cause Health Damage) ...................................................................................................195
Table 12-2. Domestic Adverse Event Reports (Event Resulted in Health Damage).......................... 195
Table 12-3. Foreign Device Malfunction “Near Incident” Reports (Event had the Potential to
Cause Health Damage).................................................................................................... 195
Table 12-4. Foreign Adverse Event Reports (Event Resulted in Health Damage). ............................195
Table 13-1. Timeframe for Reporting an MDAE in India................................................................. 235
Table 14-1. Pecuniary Sanctions. ........................................................................................................246
Table 15-1. Pecuniary Sanctions ........................................................................................................259
Table 15-2. Notification Times for Periodic Reports .........................................................................269
Table 18-1. Excerpt from the Essential Performance Tables That Map to Standards. ........................321
Table 18-2. Australian TGA Recall Actions Related to Cybersecurity ..............................................332
Figures
Figure 2-1. Lifecycle of a Medical Device. ...........................................................................................24
Figure 2-2. Annual Registration Process. .............................................................................................28
Figure 2-3. FD&C Section 522 Postmarket Surveillance Process .......................................................30
Figure 2-4. How Postmarket Reports are Sent to FDA. ......................................................................36