By Stewart Eisenhart, Emergo Group
The comment period for new Health Canada guidance on the regulator’s program for providing healthcare professionals access to unlicensed medical devices under qualifying circumstances will end in late May 2015.
The Special Access Program (SAP) is designed to enable healthcare providers to utilize devices that have not yet obtained Medical Device Licenses (MDL) or Medical Device Establishment Licenses (MDEL) either for emergency use or in cases where more conventional devices or therapies are inappropriate or ineffective. SAP also makes allowances for use of customized devices to treat unique patient diseases or conditions.
Which devices qualify for the SAP?
According to the Canadian Medical Devices Regulations, any Class I device whose manufacturer does not currently hold an MDEL or any Class II, III or IV device whose manufacturers lack an MDL qualify for inclusion in the SAP.
How does the SAP work?
The draft guidance states that anyone entitled under Canadian provincial law to perform healthcare services may apply for access to an unlicensed or custom-made device under the SAP. But successfully applying for such devices under the SAP comes with strings attached: Applicants are expected to “become familiar with all relevant information about an unlicensed medical device prior to requesting access to it,” the guidance states, and must report any adverse events related to SAP devices to both Health Canada and to manufacturers or importers.
Only qualifying healthcare providers may apply for SAP participation; manufacturers and importers may play no role in the application process, and are also forbidden from promoting or advertising (much less selling) unlicensed medical devices that qualify for SAP inclusion.
Health Canada’s review process
SAP applicants can expect rigorous reviews by Health Canada to determine whether their requests follow CMDR requirements. Applications are considered on a case-by-case basis, and timeframes are determined by when patients would require procedures involving unlicensed devices.
According to Canadian medical technology trade group MEDEC, Canadian regulators are soliciting industry comment on the new draft guidance on the SAP qualification and review process through May 25, 2015.
Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.
