Medical device regulation has been expanded and a number of new obligations have been announced
Amendments made by the Turkish Medicines and Medical Devices Agency to the Medical Device Sales, Advertising and Promotion Regulation have added a number of new definitions covering direct sales, placing and keeping products on the market, a new ‘single declaration’, consumers and consumer referrals. There has been a change in the scope of internet advertising and sales to consumers and certain direct sales to consumers have been banned. Obligations for medical device registration and notification to the Board have been expanded and new sanctions have been introduced for failure to comply with the advertising and sales ban.
Medical devices that are allowed to be advertised and sold through the internet by registered sales centers are those that fall outside of the scope of devices sold, adapted or applied solely in hearing aid centers, custom-made prosthesis and orthotics centers, optician institutions and dental prosthesis laboratories, used and applied exclusively by healthcare professionals or applied in medical device sales centers. Items such as toothpaste, dental prosthesis care products, condoms, cotton, band-aids and similar items listed in Annex-3 of the regulation are not subject to the advertising ban according to the regulation.
Restrictions now apply to direct sales through newspapers and television & radio and to placing and keeping products on the market for direct sales to consumers. Any advertising or sales through the internet of medical devices that are sold, adapted or applied solely in hearing aid centers, custom-made prosthesis and orthotics centers, optician institutions and dental prosthesis laboratories that are intended to be used and applied exclusively by healthcare professionals or applied in medical device sales centers are also now restricted.
A sales ban of 15 days has been introduced for failure to comply with the advertising and sales ban for certain devices upon warning from the authority.
The regulation has introduced the term “single declaration” obliging sales centers to implement single action notification procedures in order to monitor information after registration of medical devices placed or kept on the market by sales centers in the systems established by the Authority.
The term direct sale is introduced to the regulation for the first time as:
'' A marketing system offered to consumers in the consumers’ home or office with single or multi-tier sales methods by those acting under the names of sales representatives, distributors’ agents and similar names who are either employed or not by any direct sales company.’ With the subsequent reference, a prohibition was introduced stating that medical devices are prohibited from being placed or kept on the market through newspapers, radio, television and telephone sales or direct sales methods
Article 3 of the relevant regulation amendment explains the definition of the newly introduced referral concept as follows: ‘’Systematic actions or behaviors towards the consumer, directing them to a certain sales center or a specific healthcare provider by persuasion, suggestion or other means.’’ Sales Centers are prohibited from refering users to any healthcare organisation or healthcare professional or from the referral of users to their offices.
With the current regulation, dental prosthesis laboratories included by the Dental Prosthesis Laboratory Regulation are excluded from the scope of the regulation.
In the event that responsible managers are dismissed, resign or no longer meet the necessary requirements to remain as a responsible manager, sales centers must notify the provincial health directorate within 10 days and within 20 days upon the death of a responsible manager. It is now a requirement to appoint a new responsible manager following the instance of such events. If a sales center does not appoint a new responsible manager within 30 days, medical device sales activities will be temporarily suspended until one can be appointed.
Finally, except for those devices used in pharmaceutical form and for the application of medicinal products for human use, devices used or applied exclusively by healthcare professionals are no longer available for sale at pharmacies.
The Medical Device Advertising and Promotion Regulation has been amended by the relevant authority of the Turkish Medicines and Medical Devices Agency. With these new amendments, the scope of the medical device regulation, which is a regulatory field, has been expanded and new obligations have been added. The changes will concern companies that sell medical devices directly, such as sales centers. Changes within the scope of advertising will affect consumers and relations with consumers in regard to the medical devices that can be sold on through Internet. As a result, the regulation requires medical device companies to meet with the new amendments, to take the necessary steps in terms of compliance and to receive legal support on the issue.