Jurisdiction-Specific Regulatory Readiness
One Audit Model - Five Regulatory Overlays
MDSAP creates a common audit framework, but each participating jurisdiction retains its own regulatory obligations. The manufacturer must be able to demonstrate that market authorization, establishment requirements, reporting obligations and other country-specific controls are current and linked to the QMS.
Australia
Therapeutic Goods Administration (TGA)
Brazil
Agência Nacional de Vigilância Sanitária (ANVISA)
Canada
Health Canada (Mandatory for Class II, III, IV)
Japan
Ministry of Health, Labour and Welfare (MHLW) / PMDA
United States
U.S. Food and Drug Administration (FDA)
Our Jurisdiction Readiness Support Includes
- Australia: TGA-facing QMS and regulatory control mapping
- Brazil: ANVISA-specific QMS and regulatory obligation mapping
- Canada: Health Canada medical device licensing and MDSAP dependency readiness
- Japan: MHLW / PMDA regulatory requirement mapping
- United States: FDA QMS (21 CFR Part 820 / QMSR) and regulatory requirement mapping
- Device registration / listing status review across all target markets
- Facility registration / licensing control
- Country-specific complaint and adverse-event reporting logic
- Advisory notice / recall requirement mapping
- Local record-retention and regulatory communication controls
- Regulatory change monitoring and implementation evidence
What the Auditor Is Really Testing
- Whether market authorization status matches devices actually supplied to customers
- Whether registrations and facility obligations remain current with health authorities
- Whether reportability decisions systematically consider every applicable jurisdiction
- Whether local regulatory actions are integrated into CAPA and engineering change control
- Whether the QMS can show evidence for each country without contradictory procedures
How NKB Regovanta Approaches It
We build a jurisdiction-to-process map rather than a country-by-country binder. For each applicable requirement we identify the process owner, trigger, decision logic, record, escalation route and evidence location. This allows an auditor to move from an MDSAP task into the relevant country requirement without finding a regulatory gap.
Ready to Harmonize 5 Country Requirements?
Let NKB Regovanta embed country-specific regulatory logic across your entire medical device quality management system.