MDSAP · Medium · 13 min lesson
Chapter 2 Device marketing authorization and facility registration - evidence, changes and notification
MDSAP AU P0002 Audit Approach, Chapter 2 (3 tasks); ISO 13485:2016 clauses 4.1.1, 4.2.1, 5.2, 7.2.1, 7.2.3 and 7.3.9
What you will learn
- Audit the 3 authorization and registration tasks.
- Verify evidence per country.
- Judge change notifications.
Key takeaways
- Chapter 2 has three tasks: submission and registration, evidence of clearance, and notification of changes; it is audited as a linkage from Management and Design and Development.
- Use the label to settle who the legal manufacturer is, then check registration and listing against it.
- Trace from the sales list to the authorization for each model and country, and check that clearance came before distribution.
- Every change needs a recorded regulatory decision per market: notify, amend, approve first, or no notice with a reason.
- Country rules differ (Brazil, Canada, Japan, United States, Australia), so keep a table by country and confirm current rules before relying on it.
Free practice question
An importer has told the Brazilian regulator that Oriel is the legal manufacturer. The labels name Oriel. Oriel says it is only a contract supplier to a brand owner.
What should the auditor do under MDSAP Chapter 2 task 1?
Use the labels as evidence of the legal manufacturer and check registration and listing against it
Correct. MDSAP Chapter 2 task 1 states that labelling helps to establish who is the legal manufacturer.
Accept the contract supplier claim without evidence
Not quite. A claim alone does not settle legal manufacturer status under MDSAP Chapter 2 task 1.
Close the task because the importer holds the registration
Not quite. MDSAP Chapter 2 task 1 still checks that the organization applied registration requirements.
Ask the regulator to decide during the audit
Not quite. MDSAP auditors gather evidence themselves under Chapter 2 task 1 and do not wait for a ruling.
Key terms
- legal manufacturer: The party regulators hold responsible for the device; the label is evidence of who it is (MDSAP Chapter 2 task 1).
- facility registration and device listing: Registering or licensing facilities and submitting device information to regulators (MDSAP Chapter 2 task 1).
- marketing authorization: Clearance, licence, registration or approval to market a device in a jurisdiction (MDSAP Chapter 2 task 2).
- sponsor: In Australia, the party that includes the device in the register; the sponsor holds the entry (MDSAP Chapter 2).
- significant change: A change that may need new approval, such as sterilization method, materials, site or software version in Brazil (MDSAP Chapter 2 task 3).
- linkage: Chapter 2 is audited as a link from the Management and Design and Development processes (MDSAP Audit Approach).
Official sources
- MDSAP AU P0002.009 MDSAP Audit Approach (FDA)
- MDSAP AU P0037.001 Guidelines on the use of the nonconformity grading system for MDSAP purposes (FDA)
- Medical Device Single Audit Program (MDSAP) Frequently Asked Questions (FDA)
- ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes
Go further
The full lesson has narrated slides, more scenario questions with explained answers and a simulation.
Open the AcademyWatch on YouTubeIllustrative example. Educational only, not legal advice.