Quick Link: Country Overview | Why MDSAP | Key Topics of MDSAP
MDSAP
Medical Device Single Audit Program (MDSAP)
The MDSAP is an audit program that is composed of the following five jurisdictions: USA, Australia, Canada, Japan and Brazil.
Country Overview:
USA – FDA: Food and Drugs Administration
The quality management requirements are based on QSR – 21 CFR Part 820.
Australia – TGA: Therapeutic Goods Administration
The quality management requirements are based on TGA regulation (TG(MD)R Sch3).
Brazil – ANVISA: Agência Nacional de Vigilância Sanitária
The quality management requirements are based on RDC ANVISA 16/2013.
Canada – Health Canada:
The quality management requirements are based on ISO 13485:2016.
Japan – MHLW & PMDA: Ministry of Health Labor and Welfare & Pharmaceuticals and Medical Devices Agency
The quality management requirements are based on MHLW Ordinance No. 169.
Europe – Not part of the MDSAP program (observation roll):
The quality management requirements are based on ISO 13485:2016.
Why MDSAP:
Benefits:
The main benefits of this program are:
- Reduction of external Audits
- Better market access
- Positive image of your Company and quality
Risks:
Risk of the MDSAP program could be:
- Transparency
- Follow-up Audits
- Audit not passed – Sales stop in all five countries
Key Topics of MDSAP:
Audit Grading of nonconformities:
The MDSAP grading system has five grading levels and each nonconformity will be calculated with the following system:
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Indirect nonconformities (Chapter 4.1 to 6.3) are the low-risk issues and normally starting with grading level 1 (first nonconformity) or grading level 2 (repeated nonconformity). Depends on the deviation, additional gradings can be put on top. For example, the deviation has an absence of procedure or it ends in a non-conformity product on the market (+1 Level each).
Direct nonconformities (Chapter 6.4 to 8.5) are the high-risk issues and starting at grading level 3 (first nonconformity) or grading level 4 (repeated nonconformity). Depends on the deviation, additional gradings can be put on top. For example, the deviation has an absence of procedure or it ends in a non-conformity product on the market (+1 Level each).
When you will not pass the MDSAP audit:
If the Auditing Organization finds three or more 4 levels or one or more 5 levels.
Timeline after the Audit:
The timeline below shows steps to be taken to improve processes and procedures following the audit.
Our MDSAP integration solution:
MDSAP vs ISO 13485:2016 Checklist – Click here to get our test version.
