QMS, audit & inspection by country

iso relation: local qms with iso evidence · local regime: ANMAT BPF and local establishment controls. · iso role: ISO 13485 is supporting evidence, not an automatic BPF waiver. · mdsap role: affiliate audit report and certificate use

iso relation: regulatory qms aligned with iso · local regime: Australian conformity assessment/QMS requirements with TGA acceptance of eligible overseas evidence. · iso role: ISO 13485 certificate alone does not create ARTG inclusion. · mdsap role: rac member audit reuse

iso relation: local qms with iso evidence · local regime: EAEU common QMS assessment/inspection plus member state execution. · iso role: ISO 13485 is evidence but does not replace EAEU QMS assessment where required. · mdsap role: no explicit reuse verified

Each manufacturer must establish and maintain a quality system that meets RDC 665/2022 and ensures that manufactured products are safe, effective, and adequate for their intended use.

iso relation: national gmp beyond iso · local regime: Brazil BGMP/CBPF, with ANVISA inspection powers. · iso role: ISO 13485 alone is not Brazilian CBPF. · mdsap role: rac member inspection planning and reliance

iso relation: mdsap supersedes plain iso for licensing · local regime: MDSAP certificate required for ordinary Class II IV MDL licensing. · iso role: Plain ISO 13485 certification is not the required substitute for MDSAP. · mdsap role: rac member mandatory for class ii iv

iso relation: iso certificate required in defined scope · local regime: ARCSA product registration; ISO 13485 explicitly applies to domestic manufacturing in the captured rule. · iso role: Certificate scope and manufacturer identity must match; it does not replace product registration. · mdsap role: no explicit reuse verified

iso relation: international quality certificate route · local regime: EDA route differentiates devices with recognized international quality certificates. · iso role: ISO 13485 can be qualifying dossier evidence but does not itself issue Egyptian registration. · mdsap role: no explicit reuse verified

iso relation: national schedule aligned beyond iso · local regime: Fifth Schedule QMS plus Indian audits/inspection powers. · iso role: Importer submits quality certification, but ISO 13485 does not displace the Fifth Schedule or local audit. · mdsap role: no explicit reuse verified

iso relation: iso or equivalent dossier evidence · local regime: Reference market and local registration evidence. · iso role: ISO 13485 is quality evidence, not direct Israeli authorization. · mdsap role: affiliate audit report and certificate use

iso relation: national qms aligned with iso additions · local regime: MHLW Ordinance 169 aligned with ISO 13485:2016 plus Japan specific additions. · iso role: Plain ISO certificate does not replace Japanese QMS conformity assessment. · mdsap role: rac member streamlines qms inspection

iso relation: iso certificate dossier and cab evidence · local regime: Act 737 conformity assessment plus MDA registration. · iso role: ISO 13485 supports CAB/MDA evidence but does not replace either step. · mdsap role: affiliate audit report and certificate use

iso relation: local gmp with iso evidence · local regime: NOM 241 device GMP plus registration. · iso role: ISO 13485 is supporting evidence, not a NOM 241 or registration substitute. · mdsap role: affiliate recognized for gmp evidence

iso relation: national or eaeu qms with iso evidence · local regime: Russian/EAEU QMS evaluation and inspection. · iso role: GOST ISO 13485/ISO 13485 documents can be evidence, but local/EAEU assessment powers remain. · mdsap role: no explicit reuse verified

iso relation: iso certificate required with local additions · local regime: SFDA QMS requirements plus Saudi regulatory duties. · iso role: ISO 13485 is required evidence in applicable routes, not a substitute for MDMA. · mdsap role: no explicit reuse verified

iso relation: multiple qms evidence types accepted · local regime: Dealer/manufacturer QMS plus product registration. · iso role: HSA accepts ISO 13485, MDSAP and named foreign regulatory QMS evidence in defined contexts; none replaces product registration. · mdsap role: official observer and certificate evidence

iso relation: iso certificate prerequisite for establishment · local regime: SAHPRA establishment licence and local quality manual/site controls. · iso role: ISO 13485:2016 became a prerequisite for relevant establishment licence approvals; it is not itself the licence. · mdsap role: affiliate audit report and certificate use

iso relation: national qms aligned with iso additions · local regime: KGMP aligned with ISO 13485 but retained as national conformity. · iso role: Plain ISO 13485 does not replace KGMP certification/assessment. · mdsap role: affiliate audit report and certificate use

iso relation: national qms certificate with simplified foreign evidence · local regime: Taiwan Medical Device QMS conformity, usually renewed every three years. · iso role: ISO 13485 evidence can support simplified review but does not automatically create Taiwan QMS conformity. · mdsap role: affiliate reports accepted in defined simplified modes

iso relation: uk regulatory qms with iso evidence · local regime: UK MDR QMS/conformity requirements plus registration. · iso role: ISO 13485 supports the QMS but is not a UKCA certificate. · mdsap role: official observer no automatic substitution

iso relation: iso incorporated with us additions · local regime: FDA QMSR effective 2026 02 02 incorporates ISO 13485:2016 by reference with US specific requirements and FDA inspection powers. · iso role: An ISO 13485 certificate is not FDA approval and does not bar FDA inspection. · mdsap role: rac member may reduce routine inspection burden