MDSAP gap analysis checklist
Start with an evidence register: what your quality system requires, which record demonstrates it, who owns the gap and how closure will be checked. This worksheet helps Malaysian manufacturers prepare for an MDSAP scoping discussion.
Define the scope first
List the sites, device families, outsourced activities and markets in scope. Identify the current document owner for each area. Keep commercial launch targets separate from evidence that is ready for assessment.
MDSAP evaluates a quality system against ISO 13485 and applicable participating-country requirements. The prompts below follow the seven areas in the FDA-published MDSAP Audit Approach; use the official document for complete tasks and country-specific requirements.
Seven areas to check
| Audit area | Evidence to locate |
|---|---|
| Management | Quality objectives, responsibilities, training and management-review actions. |
| Market and facility authorizations | Device approvals, facility registrations and change assessments for applicable markets. |
| Measurement and improvement | Complaint trends, internal audits, corrective actions and effectiveness records. |
| Incident and safety-notice reporting | Reporting decisions, deadlines, submissions and safety-action records. |
| Design and development | Design reviews, verification, validation and risk-control evidence. |
| Production and service | Process validation, release records, traceability and servicing controls. |
| Purchasing | Supplier evaluation, purchasing requirements and outsourced-process controls. |
Use one row for each gap
- Reference: record the applicable task or requirement and market.
- Evidence: link the document version and a relevant completed record. Keep confidential records in your controlled workspace.
- Finding: describe the missing or inconsistent evidence in a sentence someone else can verify.
- Action: name an owner, deadline and closure evidence. Record what needs to be tested again.
- Status: use open, in progress, ready for review or closed. Explain any not-applicable decision.
A worked example
Illustration only: the supplier procedure calls for periodic evaluation, but the selected supplier file has no completed review. Record the document and supplier references, assign the purchasing owner, and set a review date. Closure needs the completed evaluation and a check that the next review is scheduled. Rewriting the procedure alone would leave the missing record unresolved.
Download the editable worksheet
Turn findings into a scoped project
Bring the register, document index and target-market list to your MDSAP readiness consultation. Separate work your team can complete from specialist work requiring validation, testing or regulatory input. Agree evidence-based milestones before fixing the audit date.
For Malaysian product submissions, use our separate MDA registration gap checklist. For the underlying quality system, see ISO 13485 implementation.
Frequently asked questions
Is this the same as an MDA registration checklist?
Does completing the checklist certify us?
Which Canadian devices require MDSAP?
Can we use it before all documents are ready?
Scope your MDSAP preparation
Share your device families, sites, target markets and current QMS status. We will scope the readiness work from the gaps.