March 2021 – The Turkish Medicine and Medical Devices Authority (“TITCK”) has recently amended the rules governing the sale and promotion of medical devices. TITCK first issued the Regulation on Amending the Regulation on the Sale, Advertising and Promotion of Medical Devices (the “Amendment Regulation”), which was published in the Official Gazette (numbered 31232) on 2 September 2020 and entered into force on that date. Subsequently, TITCK updated the Guide on the Implementation of the Medical Device Sale, Advertising and Promotion Regulation ("the Guide"), which entered into force on 11 February 2021.
The Amendment Regulation has introduced the following major changes:
- Places authorised by TITCK to sell medical devices (i.e., sales centres) are now required not only to submit data on sales of medical devices to the product tracking system (ÜTS) established by TITCK, but they are also obliged to keep this information up to date and to ensure the traceability of medical devices.
- Medical devices are grouped into three categories with regard to the applicable rules on their advertisement:
- The first category comprises medical devices that may not be advertised directly to consumers. This includes:
- devices that are only sold or modified at (i) hearing aid centres; (ii) customised prosthetic or orthotic centres; (iii) opticians; or (iv) dental prosthetic laboratories; and
- devices that are intended to be used or applied exclusively by healthcare professionals or devices that need to be inserted or attached at medical device sales centres.
- The second category includes devices that can be freely advertised to consumers. These are listed in Annex 3 of the Amendment Regulation and consist of simple medical devices such as toothpaste, condoms, cotton wool, adhesive bandages, mouthwash and dental prosthetic care products.
- The third category contains any medical device that does not fall into the above two categories. These medical devices may be advertised to consumers solely on online media where the relevant product is offered for sale and may not be freely advertised on other platforms.
- In the event of a breach of the above rules by a medical device sales centre, the relevant sales centre will first be warned by TITCK and, in the event of a failure to comply with the warning within three days of receipt, the sales activities of the sales centre may be temporarily suspended for a duration of 15 days. If the sales centre continues to carry out sales activities during the suspension period, its authorisation certificate may be cancelled.
- If an authorisation certificate is cancelled more than once, the relevant authorised person will not be able to obtain a new certificate for a period of one year (for two cancellations) or two years (for three or more cancellations).
- On 8 December 2020, TITCK announced the list of medical devices that can be sold by pharmacies. In this regard, except for medical devices that fall into the first category above, it is envisaged that the following types medical devices may be sold without obtaining a separate license or authorisation: (i) devices that are in pharmaceutical form; (ii) devices used in the application of pharmaceuticals; (iii) devices listed in Annex 3; or (iv) devices intended to be used by individuals without medical professional assistance.
- In light of the measures being taken to combat Covid-19, the Turkish Ministry of Health has been authorised to introduce exceptions regarding the use of sales channels for protective medical devices in cases of epidemics, pandemics and similar situations that affect public health.
The Guide aims at implementing the changes brought by the Amendment Regulation. In addition to providing details of such changes, the Guide introduces specific rules that govern the activity of “providing information” regarding medical devices.
The activity of “providing information” is not defined in the Regulation on the Sale, Advertising and Promotion of Medical Devices. The Guide defines it as any activity (other than marketing communication) that involves information provided by a sales centre about the technical documentation regarding a medical device on the official website that is specific to the product.
As per the Guide, only sales centres that have registered the device on the Product Tracking System (ÜTS) can perform the activity of “providing information”. The information can be provided for the product through the official website or social media accounts of the sales centre (provided that such accounts are indicated on their official website).
TITCK's recent updates above can be seen as part of the regulatory response to the circumstances caused by the outbreak of Covid-19, which has necessitated the widespread use of certain medical devices such as medical face masks, medical gloves, intubation tubes and intensive care devices. In this context, the Amendment Regulation and the Guide aim to clarify the conditions and requirements for sales channels and the advertisement of medical devices through a categorical approach, with the “safety valve” of permitting the Ministry of Health to provide for exceptions to allow for greater flexibility in public health emergencies.
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