MDSAP Upgrade Kit — ISO 13485 Edition | ISO 13485 & FDA QMSR
Getting ready for an MDSAP audit? This kit adds the requirements of the Medical Device Single Audit Program to an ISO 13485 / FDA QMSR quality system, for all five participating jurisdictions.
MDSAP auditors work through 90 audit tasks in seven chapters. Most ISO 13485 systems already cover the core tasks; the gaps are in marketing authorization and registration, reporting to five regulators on five different clocks, and country-specific requirements spread across the whole QMS. This kit closes those gaps.
New documents (11)
SOP 5-004 MDSAP Program and Audit Readiness Procedure
SOP 5-005 Marketing Authorization and Facility Registration Procedure
SOP 8-016 MDSAP Adverse Event and Advisory Notice Reporting Procedure, with deadline tables for all five jurisdictions
SOP 7-047 Servicing Procedure
QMSM-M MDSAP Annex: Scope and Regulatory Roles
FORM 0039 Marketing Authorization Register; FORM 0040 Regulatory Report Decision and Timeline Log; FORM 0041 Regulatory Partner Quality Agreement (Sponsor, MAH, registration holder, importer); FORM 0042 Regulatory Change Assessment; FORM 0043 Service Report and Service Record Review
FORM 0044 MDSAP Audit Readiness Checklist (Excel): all 90 MDSAP audit tasks mapped to procedures, evidence and country requirements
FORM 0045 MDSAP Complaint Reporting Decision Tree: a one-page flowchart from complaint intake through reporting in each jurisdiction, field action and closure, with the decision points in full and a record of the path taken
Revised procedures (33)
Each revised procedure keeps all of its existing text and adds an MDSAP Jurisdiction Requirements section, covering for example Japanese and Australian record retention, Canadian bilingual labeling and summary reports, Brazilian device history record, complaint and sampling requirements, licence amendments, auditing-organization notifications and UDI changes. Includes document control, record retention, management review, design control, design change, labeling, UDI, purchasing, supplier management, complaints, CAPA, recalls, MDR, vigilance and post-market surveillance.
Jurisdictions covered
United States: FDA QMSR, 21 CFR 803, 806, 807, 814, 830
Canada: Medical Devices Regulations SOR/98-282
Australia: Therapeutic Goods (Medical Devices) Regulations 2002
Brazil: RDC ANVISA 665/2022, 67/2009, 551/2021, 751/2022, 848/2024
Japan: PMD Act and MHLW Ministerial Ordinance No. 169
Which edition do I need?
Dual-Standard Edition: for the A.P. Lyon Dual-Standard QMS (ISO 9001:2026 + ISO 13485:2016), document numbers ending in -C
ISO 13485 Edition: for the A.P. Lyon ISO 13485 & FDA QMSR QMS, document numbers without a suffix
Built for the A.P. Lyon ISO 13485 QMS
Document numbers, cross-references and formatting match the ISO 13485 & FDA QMSR QMS Manufacturing Plus package (SOP 4-001, FORM 0020 and so on). If you use another system, the new procedures and forms work on their own and the added sections can be copied into your procedures. Microsoft Word and Excel files, with PDFs of the procedures.
Already a customer?
Past buyers of an A.P. Lyon ISO 13485 or Dual-Standard package get a loyalty discount on this kit. Email info@aplyon.com with your order number.
Why A.P. Lyon
Written and maintained by Aaron Lyon, a former Senior Director of Regulatory Affairs whose documents have been used in FDA, notified-body and ISO certification audits in 45 countries. These are working documents, kept current and expert-backed.
Scope
The kit provides documents to support MDSAP certification. It does not certify your QMS or guarantee an audit outcome, and it is not legal advice. Confirm current requirements with each regulator.
