MDSAP

 What is MDSAP and how does it benefit the medical device manufacturers

 What is MDSAP?

MDSAP refers to Medical Device Single Audit Program that conducts single audit for QMS of a medical device’s manufacturer. This audit is conducted to satisfy the multiple requirements of the regulatory standard. The audits are run by auditing bodies or auditing organizations like the BSI. These auditing bodies are authorized by the regulating authorities to conduct audits under the requirements of MDSAP. MDSAP is a process wherein the manufacturers of medical devices can be audited one time for compliance against the standard and regulatory requirements across five medical device markets or locations like the United States, Australia, Japan, Canada and Brazil. The main goal of this audit program is to leverage regulatory resources in order to efficiently manage and sustain single audit programs that are emphasized on the overall surveillance of medical device manufacturers.

Why was MDSAP developed in the first place?

The Medical Device Single Audit Program was developed for various reasons that would benefit the medical device industry in ways such as:

 lThe MDSAP single audit program was created and implemented based on the requirements mentioned in the IMDRF MDSAP Model

lAllows for appropriate regulatory surveillance of the Quality Management System of the industries that manufacture medical devices

lReduces regulatory related issues in the manufacturing industries

lAids in the efficient and effective use of regulatory resources by sharing work and mutual acceptance while respecting the authority

lGlobally promoting greater regulatory approaches and technical requirements that are based on international standards and practices

lBrings in consistent and transparent regulatory programs

lLeverages existing requirements appropriately for conformity assessments

How was MDSAP developed?

MDSAP was designed by the TGA’s representatives (Australian Therapeutic Goods Administration), Brazil’s ANVISA (Agência Nacional de Vigilância Sanitária), Health Canada, US’s FDA (Food and Drug’s Administration)and MHLW/PMDA. The regulatory authorities that participate in the MDSAP programs are usually equal partners. There are also the other regulatory authorities that decide to actively participate in the MDSAP programs. Authorities such as WHO (World Health Organization), EU (European Union) are usually the official observers for the MDSAP RAC (Regulatory Authority Council) and for the SME (Subject Matter Experts) group.

Who can apply for the MDSAP programs?

Only those auditing organizations that are recognized under the CMDCAS programs are invited to participate in the MDSAP Pilot programs. Later on, the program was open for other auditing organizations. Companies looking to implement or to know more on MDSAP can contact Omnex.

What are the advantages of implementing MDSAP?

There are many advantages upon implementing Medical Devices Single Audit Programs:

lOffers reliable schedule of audits

lBrings transparency in the industry

lEase of patient’s health and information access

lLeverages regulatory resources

lReduces disruptions of medical device manufacturers that arise due to multiple regulatory audits

lIncorporates ISO 13485 assessment

lReduction in auditing costs when compared to other independent audits

lReduction in time taken to find or track the findings as a result of multiple audits

lIncreased access to the Canadian market and Brazilian market

lMinimizes routine inspections by the FDA

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