The ‘Guideline on the Implementation of the Regulation regarding Sales, Advertisement and Promotion of Medical Devices’ (“the Guideline”) instrumented on the basis of the has been updated, thereby being added certain provisions on information, promotion, advertisement and online sales and entered into force on 12.02.2021.
The aim of the Guideline similar to the previous version, to determine the procedures and principles of the Regulation regarding Sales, Advertisement and Promotion of Medical Devices (“the Regulation”).
With this update, the Guideline provides the definitions of several terms, some of which are newly regulated and some of which are parallel to the definitions either in the Regulation or the previous version of the Guideline. The definitions of the terms ‘sales centers’, ‘promotion, ‘promotional activities, ‘medical devices sales center’ are quoted from the Regulation and the definitions of the terms ‘training’, ‘exam’, ‘medical device launch announcement’, ‘data bank’, ‘certificate of competency’, authorization’, ‘authorized institution’ and ‘regulation’ are quoted from the previous version of the Guideline. The new Guideline brings forth the below mentioned definitions to the corresponding terms:
- Free samples: Devices that are not subject to sale and given in accordance with commercial practices and in quantity and free of charge to healthcare professionals and technical staff working in the field of medical devices within the body of health institutions and organizations, within the scope of promotional activities in accordance with Article 24 of the Regulation,
- Information: The activities of the sales center conducted on official website for specific products, which includes information on the technical documentation of the medical device and does not qualify as a marketing communication,
- Devices with demo purpose: Medical devices given to healthcare service providers and healthcare professionals to be experienced,
- Consumer-oriented product: Devices for the use of real or legal persons acting for commercial or non-professional purposes.
The new rules introduced by the Guidelines are summarized below:
Information:
Information may only be provided product-specifically, by the sales centers, on their own official website or social media accounts -provided that these accounts are included in the official website of the sales center. The domain name of this website may be the name/title of the sales center or a domain name obtained for specific products.
If it is possible to switch from social media accounts to web pages on which the product is being sold, this is considered as sales activity.
Within the scope of the information, only the information in the technical documentation of the product can be shared and the price information or the questionnaire, study, etc. announced by the company cannot be included.
Promotional Activities:
Promotional activities can only be carried out by real or legal personality authorized as sales centers, only towards the healthcare professionals, with the exception of scientific meetings held by scientific associations. Promotional information and promotional materials can only be given to healthcare professionals and technical staff working in the field of medical devices within the body of health institutions and organizations. Training activities for personnel within the sales centers are not considered within the scope of promotion.
The promotional activities for medical devices cannot be based on false, misleading, exaggerated or unproven information; or via sweepstakes, games of chance and similar means. The names of the Ministry and its affiliated organizations, the names of the health institutions, organizations or persons participating in the research of the device cannot be used without permission in promotional activities.
Promotional activities of devices may contain i- information that the promotion belongs to the device, ii- the name and information of the device conforming the documents such as the declaration of conformity, EC certificate, technical file, iii- the information compatible with the purpose of use included in the label and use instructions of the device, iv- scientific reports and certificates subject to promotion, date of issue, contact information and specialty of the person or institution who prepared it, v- the relevant medical information, if the device has a therapeutic effect.
If the promotional activities are made by using materials from scientific studies, the materials must stick to the original and by duly referring to the sources. Promotional activities must contain informative and evidence-based medical information about the content of the device and in a manner to help healthcare professionals to form their own view of the therapeutic value of the device.
Promotional materials in accordance with the definition can be given to healthcare professionals and technical staff working in the field of medical devices within the body of health institutions and organizations.
Free samples & Devices with Demo Purpose:
Promotional materials in accordance with the definition in the Regulation, may be given to healthcare professionals and technical staff working in the field of medical devices within the body of health institutions and organizations. The total value of free sample cannot exceed 2 percent of the sales turnover of the relevant device in the previous year.
Manufacturers or importers can only be given free of charge infusion pumps, insulin pens, needle tips, catheters, adapters, transfer sets and similar peritoneal dialysis auxiliary materials and devices that are essential in the use of drugs such as self-blood glucose measurement systems provided that they are approved within the scope of the patient support program, and these activities are not considered within the scope of promotional activities and free samples.
Application lenses are within the scope of demo device and are not considered as free samples. Besides, samples requested within the scope of device tenders are demo device and are not considered as free samples.
Demo devices and free samples given within the scope of promotional activities must be registered in the information management system of the Authority. Technical service and clinical support activities are not considered within the scope of promotional activities.
Medical Device Launch Announcement:
If the manufacturer or importer company wants to make a medical device launch announcement, it must apply to the Authority with a copy of the announcement text for obtaining a permission. The permission given by Turkish Medicine and Medical Device Agency (“TMMDA”) for launch announcement is valid for once to be published in the same day in all written daily media and once within 30 days from the date of permission in periodical print media. The Guideline provides requirements for medical device launch announcement to comply and the documents to be included in the application made to TMMDA.
Medical device launch announcements can only be made through printed daily or periodicals, and not on the internet, even if there are versions of daily or periodicals.
Advertisement
The Guideline provides certain restrictions on the promotional activities of the medical devices towards public parallel to the Regulation. In this respect, the following devices cannot be advertised publicly; i- medical devices that are sold, adapted or applied in hearing aid centers, custom-made prosthesis and orthosis centers or optician institutions or dental prosthesis laboratories, ii- the medical devices that are required to be used or implemented exclusively by healthcare professionals or in medical device sales centers.
The promotional activities towards the public for the medical devices other than the above are permitted, but the promotional activities and advertisement of such products may be made only in the website pages where the device is sold and only by the sales centers. Advertisement through social media is also permissible, in condition that such social media account where the advertisement is made belongs to the sales center and the website pages where the device is sold can be accessed through a link given in that social media account. The Guideline strictly forbids the advertisements made through websites or social media accounts other than the ones owned by the sales center; through a pop-up, banner etc. internet advertisement features.
There are certain medical devices which are allowed to be advertised to public without constraint; namely toothpaste, dental prosthesis care products, condoms, diapers, incontinence pads, topically applied hot cold compresses, band-aid, plaster, cotton, mouthwash, breath-opening nasal tapes.
In Turkey, the advertisements must comply with the provisions of the Consumer Protection Law numbered 6502, the Law on the Establishment and Broadcasting Services of Radio and Television numbered 6112 and other relevant legislation. The Guideline also clarifies the conditions must be met, so that the advertisement activities would comply with the relevant regulations as well.
The promotional activities for medical devices cannot be based on false, misleading, exaggerated or unproven information; or via sweepstakes, games of chance and similar means. The names of the Ministry and its affiliated organizations, the names of the health institutions, organizations or persons participating in the research of the device cannot be used without permission in advertisement activities.
Commercial advertisements that deceive the consumer or exploit their lack of experience and knowledge, endanger the safety of life and property, encourage violent acts and commit crimes, harm public health, exploit patients, the elderly, children and the disabled are prohibited.
Informational content containing price information and any activity that affects the purchasing behaviour of the consumer regarding the product are considered as advertisement. On the other hand, displaying images such as brochures, posters in the interior of the sales center or sharing dealer information on the web pages of the manufacturer or importer are not considered within the scope of advertising or information.
Online Sales:
The medical devices cannot be sold by people who are not authorized according to the provisions of the Regulation. Moreover, the devices that are not registered on ÜTS (Product Tracking System) cannot be sold. Launching or making available the medical devices on the market through newspapers, radio, television and telephone sales or direct sales to the consumer is prohibited.
The devices that cannot be advertised publicly, also cannot be sold on the internet towards public. The online sales of such type of medical devices can only be made by authorized sales centers through their own websites.
Sales can be made from the social media accounts of the sales center, provided that the social media accounts belong to the sales center and that the website page where the online sale is made, is accessible from the social media account via a link.
The Guideline, some provisions of which are summarized above, has entered into force on February 12, 2020 by abolishing the previous Guideline. The Guideline was quite needed, upon the recent change made to the Regulation in September, 2020 and it further enlightens the implementation of the Regulations.