Can an MDSAP audit include combination products

The implementation of the MDSAP is intended to allow for a single audit to satisfy the regulatory requirements of the participants. 

Medical devices that include pharmaceutical (medicinal substances) or biologics (e.g. materials of animal origin that have been rendered non-viable, or tissues, cells or substances of microbial or recombinant origin, human blood or extracts of human blood or blood products, etc.), i.e. “combination products”, may be included in the scope of an MDSAP audit.   

The RAs that take into account MDSAP audit reports for combination products expect that the AO, when conducting an audit for these products, will: 

  • undertake, to the extent possible during on-site audits, an assessment of the product- and process-related technologies in accordance with the requirements of N3 Clauses 9.2.4, 9.3.2 and 9.4.1, and the requirements of the MDSAP audit approach for compliance with the country-specific requirements   

  • assign relevant technical competence to the audit team that is assessing the product- or process-related technologies and relevant controls for the handling, testing and manufacture of these types of devices

However, due to differences in the way that these products are regulated in the jurisdictions of the participating RAs, MDSAP audit reports and certification documents may not be considered an alternative to the inspection and assessment requirements in some jurisdictions. See details below: 

Australia: Combination product manufacturers can utilise MDSAP audits and certification regardless of their chosen conformity assessment route. If the manufacturer applies for TGA Conformity Assessment certification as their conformity assessment route and have undergone a MDSAP audit, then the MDSAP audit report content will be considered and may abridge (replace or reduce the audit time) for TGA initial audits or future surveillance audits of the manufacturer.  Applications utilising TGA Conformity Assessment certification will not undergo an Application Audit when submitting an application for marketing authorisation.

Alternatively, manufacturers holding MDSAP certification, and via their Australian Sponsor, have the option to submit suitable Comparable Overseas evidence including a MDSAP certificate to apply for marketing authorisation in Australia. The TGA may select ARTG applications supported by Comparable Overseas evidence for an Application Audit.  

Brazil: According to Brazilian regulations, there are no specific requirements for combination products regarding the QMS, and for that, all the requirements already included in the MDSAP Audit Approach promotes adequate coverage for the needs established in the Brazilian legislation and regulation for those products. Therefore, combination products that are considered medical devices in Brazil are included in MDSAP. 

Canada: The MDSAP Audit Approach covers the requirements for combination products that are regulated as medical devices. 

Japan: There are no Japanese characteristic requirements for combination products which are categorized as devices.  Therefore, MDSAP Audit results will be considered as alternatives to confirm the compliance of QMS requirements for such products. 

United States: The MDSAP Audit Approach only covers the requirements of the US medical device regulations.  As additional requirements of the US regulations apply to devices incorporating drugs or biologics, the FDA cannot consider MDSAP - audits of combination product manufacturers as an alternative to FDA inspections. Consequently, such products are still subject to FDA inspections regardless of the participation of the manufacturer in the program. Nevertheless, the FDA may take into account the outcome of an MDSAP audit covering combination products to optimize the scope of the FDA inspection to be performed.  

NOTE:  When a combination product manufacturer also manufactures non-combination products, it is expected that during the initial certification audit and at least once during the subsequent certification cycle the audit team includes the technical competence to audit combination products; and, when applicable, the audit plan includes the quality management system processes and activities associated with the combination product.  MDSAP audit plans and reports of combination product manufacturers must consider, where applicable:  

  1. Supplier Controls and acceptance activities (including testing) associated with the starting material that is to be used in the manufacture of the drug or biologic component (in particular, Active Pharmaceutical Ingredients)       

  2. Controls of the manufacturing processes for the drug or biologic component

  3. Final acceptance and testing activities, including those associated with the drug or biologic component in the finished product

  4. Stability programs that consider the drug or biologic component in the finished product.