Regulatory requirements are constantly subjected to changes. In June 2018 there were several important novelties. Within one current seleon project one Guidance Document is of special importance: GN-08-R2 Guidance on Medical Device Advertisements and Sales Promotion. It contains requirements regarding advertisements of medical devices in Singapur.
The crucial novelties and aspects of GN-08-R2 at a glance:
Section 3: New definition of Advertisement added, new definition of „professional use only medical device“ and „Qualified practitioner“ added
Section 4: Detailled stipulations for exploiting testimonials etc., no advertisement of „professional use only medical devices“
Section 5 addresses general rules for advertisement, including use of scientific data, truthfulness, no exaggerating or frightening advertisement
Completely new section 6: Corrective measures in relation to contravening advertisement – Guidance on dealing with incorrect advertisement, including public announcement
Completely new section 7: Feedback on Advertisements – Encouragement to report illicit advertisement
Further novelties of June 2018:
You may have noticed that you must constantly keep an eye on the regulatory requirements and adapt to them. The appropriate steps we take for approaching product certification and how we implement them in conformity and safely, you can now follow our clinical study in Singapore for instance. We will follow up on this within the next weeks.
PS: And if you wish to become familiar with the upcoming novelties of the HSA in the meantime, we recommend you to take a look at the Draft-Guideance Documents and to forward any change requests to the HSA.
Please use the Template for Comments to provide any inputs on the draft Guidance Documents.
Please note that the details and bullet points listed are not intended to be exhaustive, are supplied without liability and only serve as information.