Home › Industries › Healthcare Life Sciences › Regulators HLS regulators TeamSync supports. The map below shows the regulators most relevant to HLS deployments and the rules / standards each enforces. For each, the relevant TeamSync overlay is linked.
For per-regulator evidence packs, contact an HLS solutions engineer .
Drug + biologic + device authorities. Regulator Scope Relevant overlays FDA (US)Drugs, biologics, devices, food 21 CFR Part 11 + 21 CFR 312 + 314 + 600 + 803 + 820EMA (EU)EU centralised authorisation EU GMP Annex 11; EU CTR 536/2014 MHRA (UK)UK post-Brexit medicines + devices UK GMP + GCP; UK CTR transition PMDA (Japan)Japanese pharma + device J-GMP + ICH-aligned NMPA (China)China pharma + device NMPA framework Health Canada Canadian pharma + device Canadian GMP (Division 2) TGA (Australia)Australian pharma + device TGA GMP ANVISA (Brazil)Brazilian pharma + device RDC frameworks
Privacy + healthcare-data authorities. Regulator Scope Relevant overlays HHS OCR (US)HIPAA enforcement HIPAA ICO (UK)UK GDPR + DPA 2018 UK GDPR / ICO guidance EDPB + national DPAs (EU)EU GDPR GDPR Art. 17 CDSCO + DPDP authority (India)India healthcare data DPDP Act
Standards bodies + accreditation. Body Scope Relevant alignment ICH International harmonisation E6(R3), E2A/B, Q-series CDISC Clinical data standards CDISC-aligned DIA Drug information association TMF Reference Model The Joint Commission US hospital accreditation Information management NCQA US health-plan accreditation HEDIS measures HITRUST Healthcare-extended security CSF
AI-specific regulator activity. Body Scope Relevant overlay FDA AI/ML SaMD Software-as-medical-device with AI Algorithm change protocol EU AI Act High-risk healthcare AI EU AI Act ONC HTI-1 US algorithmic transparency Per-feature documentation CHAI Coalition for Health AI assurance standards Industry alignment
Per-regulator evidence packs. For each regulator above, TeamSync can generate an evidence pack mapping the customer's deployment to the regulator's specific control / rule expectations.