MDSAP

Medical Device Single Audit Program

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 & PMDAMinistry 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:

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.