Our engagement in the Medical Device Single Audit Program (MDSAP) journey, on behalf of members, has taken us the different parts of the world, over the past year or so. Even if it is mostly via very late night online calls. It’s important to make sure our members’ voice is heard and that the single audit program works to smooth the path for our members in conformity assessment audits.
PTA is a member of the Global Medical Devices Group which now participates in Bilateral meetings with the MDSAP organisation. This is a first and still a relatively immature development, given that regulators have been very reluctant to include industry in discussions.
Aileen O’Connor (Head of our Technical And Regulatory Standing Committee – TARSC) attended the MDSAP meeting in Kyoto, Japan and Dean attended online. Industry stakeholders attended the meeting, which brought together regulators, auditing organizations, and industry representatives from both MDSAP and non-MDSAP countries. Regulatory Authorities presenting across the 2 day open session included: HSA Singapore, TGA (Australia), US FDA, Health Canada, MHRA (UK), MHLW / PMDA (Japan), ANVISA (Brazil), MFDS (Korea), SFDA (Saudi Arabia), Industry Associations and International Groups; PTA/AUSBIOTECH/MTAA(Australian Industry) ABIMED/ABIMO/CBDL(Brazil), Medtech Canada, JIRA/JFMDA(Japan) AdvaMed(USA).
Overall, the meeting was deemed very successful and informative with the clear goal of expansion of MDSAP – APAC expansion remains a key strategic focus for the program and was seen to be generally favourable by APAC regulators but will take a lot of program support and time for many APAC countries to become even progress from Affiliate members to official observers.
We’ll break down more highlights of this meeting in the August edition of the PTA Pulse member newsletter