MDSAP is a hot topic right now for all medical device legal manufacturers.
In a nutshell, MDSAP certification by an approved Auditing Organisation (AO) proves that your company’s Quality Management System (QMS) is compliant to the Australian, Brazilian, Canadian, Japanese and US medical device regulatory requirements.
The certification has the potential to reduce your audit burden. The concept is that once you hold MDSAP certification, you should not expect audits from the Regulators in the five above geographies.
We’re still learning as an industry about whether we are guaranteed no additional audit activity. A risk-based approach will most likely apply. If your company maintains an appropriate and expected post-market performance for all devices globally, then additional audit is unlikely.
Health Canada have been the first Regulatory Authority to insist on MDSAP certification for legal manufacturers who distribute product to Canada. From the 1st of January 2019, manufacturers need to have obtained their MDSAP certification or have evidence that they are awaiting their MDSAP audit by their chosen AO.
Most of my client’s interest in MDSAP certification is being driven by their goal to launch product in the US. MDSAP certification is costly. I highly recommend shopping around the various AOs to obtain the right fit for your organisation. Consideration must be given to whether it is worth investing in the certification if your company does not plan to market devices all five countries.
When planning for MDSAP certification, the following steps will prove useful:
1: Training – You will need to show evidence of training on MDSAP in your certification audit. Plus; the training helps you understand the process, the variation in requirements across the geographies and affords you an opportunity to plan for your QMS updates.
2: Update your QMS – Use the MDSAP Companion Document to upgrade your QMS to meet the regulatory requirements.
3: Perform a gap analysis internal audit of your QMS – A MDSAP-trained internal auditor will identify any further gaps between the QMS and the requirements. This internal audit ensures your confidence and readiness for the real audit.
4: MDSAP Audit – Execute the MDSAP audit with your chosen AO. The audit itself will be intense and extremely busy as the auditors need to cover a huge range of requirements in order to satisfy themselves that your organisation is compliant.
5: Audit Close Out – No organisation wants to have audit findings. But it can be an inevitable part of any process. Especially since we work in an industry that operates on the principle of continuous improvement.
6: Celebrate Success – Enjoy a moment to celebrate the huge achievement of obtaining MDSAP certification. It is an important moment in any organisation’s journey. Your staff will thank you for taking a moment out to party and rejoice.
7: Maintenance – Be vigilant of regulatory changes in the five countries. Your AO’s maintenance audit cycle will spot if you start to let your focus slip. The Regulators will be watching MDSAP annual performance.
For more information on MDSAP, check out the resources section on my website. I am here to help. Do not hesitate to reach out if you require any MDSAP support.
Take care and best wishes,