Global Medical Device Regulatory Strategy
ix Regulatory Affairs Professionals Society
Tables
Table 1-1. Main Type of Coding in the US Healthcare Reimbursement System. ...................................................8
Table 3-1. Example Development Phases. .............................................................................................................24
Table 3-2. Regulatory Pathway Assessment Elements. ..........................................................................................36
Table 3-3. Regulatory Strategy and Plan Elements................................................................................................37
Table 3-4. Ebb and Flow of Core Team Member Involvement..............................................................................42
Table 4-1. GRS Simplified Element Table.............................................................................................................48
Table 4-2. Regulatory History Considerations.......................................................................................................51
Table 4-3. Tools or Treatment. ...............................................................................................................................52
Table 4-4. Expanded Example of the GRS Element Table....................................................................................56
Table 4-5. Regulatory Submission Requirements...................................................................................................57
Table 4-6. Summary of Regulatory Risks...............................................................................................................57
Table 5-1. Key Differences Between ISO 9001 and ISO 13485. ...........................................................................59
Table 5-2. Similarities Between ISO 9001 and ISO 13485....................................................................................60
Table 5-3. Applicability of ISO 13485 in Various Global Jurisdictions..................................................................64
Table 5-4. Benefits and Barriers to Certification....................................................................................................71
Table 5-5. Certification Body QMS Assessment Objectives, Scope, and Criteria..................................................72
Table 5-6. Audit Duration for Medical Device ISO 13485 Audits Based on Staff Numbers. ...............................73
Table 5-7. Factors That May Increase or Reduce Audit Durations. .......................................................................73
Table 6-1. Project Risk Mitigation Strategies ........................................................................................................88
Table 6-2. Overview of Tools Used within Risk Management...............................................................................91
Table 6-3. IMDRF Code Mapping to ISO 14971.................................................................................................95
Table 7-1. Comparison of Terminology “Label vs. labeling” in the US and EU...................................................100
Table 7-2. Key Medical Device Labeling Regulations in the US: Code of Federal Regulations. .........................100
Table 7-3. Key Medical Device Labeling Regulations in the EU MDR..............................................................102
Table 7-4. ISO FDIS 20417: Medical Devices—Information to be Supplied by the Manufacturer ...................103
Table 9-1. The Universal Elements of GLP..........................................................................................................124
Table 9-2. Examples of GLP Violations From FDA Warning Letters. ...............................................................125
Table 9-3. Sources of Device Risk........................................................................................................................126
Table 9-4. Biocompatibility Tests. ........................................................................................................................127
Table 9-5. Medical Device Classification Based on the Nature of Body Contact and Contact Duration. ...........128
Table 9-6. Basic Animal Study Protocol Elements...............................................................................................128
Table 9-7. Animal Models for In Vivo Medical Device Assessment....................................................................130
Table 9-8. International Animal Research Laws, Policies and Guidelines. ..........................................................131
Table 9-9. Useful Web Resources for Planning and Conducting Animal Studies in Accordance with Three Rs
Principles.........................................................................................................................................................131
Table 9-10. Questions a Company Should Consider When Selecting a CRO. ...................................................132
Table 16-1. Example of a CV Medical Device Company Product Development Matrix ....................................208
Table 16-2. Country-Specific Information from the Handbook of Pharma and MedTech Compliance.............214
Table 16-3. High-Level Marketing and Advertising Information for Countries in Asia-Pacific.........................215
Table 16-4. High-Level Marketing and Advertising Information for Countries in Europe. ...............................216
Table 16-5. High-Level Marketing and Advertising Information for Countries in Latin America and South
America...........................................................................................................................................................217
Table 17-1. African and Middle Eastern Regulatory Agencies............................................................................229
Table 17-2. Asia/Pacific Regulatory Agencies......................................................................................................231
Table 17-3. European National Competent Authorities. .....................................................................................232
Table 17-4. Eastern European Agencies...............................................................................................................233
Table 17-5. Latin American Regulatory Agencies. ..............................................................................................234
Table 17-6. North American Regulatory Agencies. .............................................................................................234
Table 17-7. Global Regulatory Professional Trade Organizations........................................................................236
Table 17-8. Miscellaneous Resources. ..................................................................................................................240
Table 17-9. African/Middle Eastern Intelligence Resources................................................................................242
Table 17-10. Asia/Pacific Intelligence Resources. ................................................................................................242
Table 17-11. European Intelligence Resources.....................................................................................................242
Table 17-12. Latin American Intelligence Resources...........................................................................................243
ix Regulatory Affairs Professionals Society
Tables
Table 1-1. Main Type of Coding in the US Healthcare Reimbursement System. ...................................................8
Table 3-1. Example Development Phases. .............................................................................................................24
Table 3-2. Regulatory Pathway Assessment Elements. ..........................................................................................36
Table 3-3. Regulatory Strategy and Plan Elements................................................................................................37
Table 3-4. Ebb and Flow of Core Team Member Involvement..............................................................................42
Table 4-1. GRS Simplified Element Table.............................................................................................................48
Table 4-2. Regulatory History Considerations.......................................................................................................51
Table 4-3. Tools or Treatment. ...............................................................................................................................52
Table 4-4. Expanded Example of the GRS Element Table....................................................................................56
Table 4-5. Regulatory Submission Requirements...................................................................................................57
Table 4-6. Summary of Regulatory Risks...............................................................................................................57
Table 5-1. Key Differences Between ISO 9001 and ISO 13485. ...........................................................................59
Table 5-2. Similarities Between ISO 9001 and ISO 13485....................................................................................60
Table 5-3. Applicability of ISO 13485 in Various Global Jurisdictions..................................................................64
Table 5-4. Benefits and Barriers to Certification....................................................................................................71
Table 5-5. Certification Body QMS Assessment Objectives, Scope, and Criteria..................................................72
Table 5-6. Audit Duration for Medical Device ISO 13485 Audits Based on Staff Numbers. ...............................73
Table 5-7. Factors That May Increase or Reduce Audit Durations. .......................................................................73
Table 6-1. Project Risk Mitigation Strategies ........................................................................................................88
Table 6-2. Overview of Tools Used within Risk Management...............................................................................91
Table 6-3. IMDRF Code Mapping to ISO 14971.................................................................................................95
Table 7-1. Comparison of Terminology “Label vs. labeling” in the US and EU...................................................100
Table 7-2. Key Medical Device Labeling Regulations in the US: Code of Federal Regulations. .........................100
Table 7-3. Key Medical Device Labeling Regulations in the EU MDR..............................................................102
Table 7-4. ISO FDIS 20417: Medical Devices—Information to be Supplied by the Manufacturer ...................103
Table 9-1. The Universal Elements of GLP..........................................................................................................124
Table 9-2. Examples of GLP Violations From FDA Warning Letters. ...............................................................125
Table 9-3. Sources of Device Risk........................................................................................................................126
Table 9-4. Biocompatibility Tests. ........................................................................................................................127
Table 9-5. Medical Device Classification Based on the Nature of Body Contact and Contact Duration. ...........128
Table 9-6. Basic Animal Study Protocol Elements...............................................................................................128
Table 9-7. Animal Models for In Vivo Medical Device Assessment....................................................................130
Table 9-8. International Animal Research Laws, Policies and Guidelines. ..........................................................131
Table 9-9. Useful Web Resources for Planning and Conducting Animal Studies in Accordance with Three Rs
Principles.........................................................................................................................................................131
Table 9-10. Questions a Company Should Consider When Selecting a CRO. ...................................................132
Table 16-1. Example of a CV Medical Device Company Product Development Matrix ....................................208
Table 16-2. Country-Specific Information from the Handbook of Pharma and MedTech Compliance.............214
Table 16-3. High-Level Marketing and Advertising Information for Countries in Asia-Pacific.........................215
Table 16-4. High-Level Marketing and Advertising Information for Countries in Europe. ...............................216
Table 16-5. High-Level Marketing and Advertising Information for Countries in Latin America and South
America...........................................................................................................................................................217
Table 17-1. African and Middle Eastern Regulatory Agencies............................................................................229
Table 17-2. Asia/Pacific Regulatory Agencies......................................................................................................231
Table 17-3. European National Competent Authorities. .....................................................................................232
Table 17-4. Eastern European Agencies...............................................................................................................233
Table 17-5. Latin American Regulatory Agencies. ..............................................................................................234
Table 17-6. North American Regulatory Agencies. .............................................................................................234
Table 17-7. Global Regulatory Professional Trade Organizations........................................................................236
Table 17-8. Miscellaneous Resources. ..................................................................................................................240
Table 17-9. African/Middle Eastern Intelligence Resources................................................................................242
Table 17-10. Asia/Pacific Intelligence Resources. ................................................................................................242
Table 17-11. European Intelligence Resources.....................................................................................................242
Table 17-12. Latin American Intelligence Resources...........................................................................................243