New Rules for Medical Device Promotion in Türkiye

What’s Changing?

Türkiye has introduced a targeted amendment to its Medical Device Sales, Advertising and Promotion Regulation, bringing new requirements for the online sale of contact lenses.

Published on 3 July 2026, the amendment strengthens regulatory oversight of online contact-lens sales and clarifies the conditions under which these products may be sold to consumers through digital channels.

The update is particularly relevant for:

• Medical-device companies operating in Türkiye

• Optician establishments

• Medical-device distributors and importers

• Companies using e-commerce channels

• Regulatory affairs and market-access teams

The amendment forms part of Türkiye’s broader regulatory framework governing the sale, advertising and promotion of medical devices.

1. New Requirements for Online Contact-Lens Sales

One of the key changes introduced by the July amendment concerns the online sale of contact lenses.

Under the amended rules, contact lenses may be sold to consumers through an internet website only where the website has been authorised by the Turkish Medicines and Medical Devices Agency (TİTCK).

The sale must also be conducted through an optician’s establishment and on the basis of a prescription.

This creates a more clearly defined regulatory framework for businesses operating in the online contact-lens market.

The amendment also provides that TİTCK may delegate the authority to approve such websites to provincial health directorates.

For businesses operating digital sales channels, this means that online distribution cannot simply be treated as a conventional e-commerce activity.

2. Digital Sales Now Require Greater Regulatory Oversight

The development is particularly significant as healthcare products increasingly move into digital commerce.

While online channels can provide greater accessibility and convenience for consumers, medical devices remain subject to specific regulatory requirements.

For companies involved in contact-lens sales, the July amendment highlights the importance of ensuring that:

• The online sales channel meets applicable authorisation requirements

• Sales are conducted through an eligible optician establishment

• Prescription requirements are properly incorporated into the sales process

• Consumer-facing activities remain consistent with Türkiye’s medical-device legislation

• Regulatory responsibilities are clearly assigned between manufacturers, distributors and local partners

Companies entering or expanding within Türkiye’s digital healthcare market should therefore assess their sales model alongside their product-registration strategy.

3. Advertising and Promotion Remain Regulated

The July amendment should also be considered within Türkiye’s wider framework for medical-device advertising and promotion.

Türkiye’s Medical Device Sales, Advertising and Promotion Regulation establishes rules governing how medical devices can be promoted and to whom promotional activities may be directed.

Certain medical devices are subject to restrictions on advertising to the general public, while promotional activities directed towards healthcare professionals and other relevant technical personnel are subject to specific requirements.

For companies operating in Türkiye, this means that product marketing cannot be separated from regulatory compliance.

Digital campaigns, promotional materials and consumer-facing communications should be reviewed carefully where they relate to regulated medical devices.

Who Should Pay Attention?

The July 2026 update is particularly relevant to:

✔ Medical-device manufacturers

✔ Importers and distributors

✔ Optician establishments

✔ E-commerce operators involved in regulated healthcare products

✔ Regulatory affairs teams

✔ Local representatives and authorised partners

✔ Companies planning to introduce medical devices into Türkiye

International manufacturers should pay particular attention when their Turkish partners are responsible for online sales, promotional activities or ongoing regulatory compliance.

What Should Companies Do Now?

1. Review Your Online Sales Model

Companies involved in contact-lens distribution should review their existing online sales arrangements and determine whether the relevant website and sales structure meet the amended requirements.

2. Verify Prescription Controls

Businesses should ensure that their online sales processes can properly accommodate prescription-based sales where required.

This includes reviewing internal procedures as well as the responsibilities of local distributors and optician partners.

3. Review Promotional Activities

Companies should assess their consumer-facing marketing, digital advertising and promotional materials against Türkiye’s medical-device advertising and promotion requirements.

A product being legally placed on the market does not automatically mean that every form of advertising or promotion is permitted.

4. Coordinate With Local Partners

International manufacturers should clarify responsibilities with their Turkish regulatory and commercial partners.

Particular attention should be given to:

• Online sales channels

• Website authorisation

• Prescription management

• Promotional activities

• Regulatory record keeping

• Ongoing compliance monitoring

  
  

5. Monitor Further Implementation

Companies should continue monitoring communications and implementation requirements from TİTCK and relevant provincial health authorities, particularly where online sales authorisations are concerned.

ARQon Insight

Türkiye’s July 2026 amendment highlights an important development in medical-device market access:

Regulatory compliance increasingly extends beyond product registration to the way products are sold, promoted and delivered to consumers.

For businesses operating in digital healthcare, this distinction is particularly important.

An online platform may function technically as an e-commerce channel, but when regulated healthcare products are involved, the sales process may be subject to additional regulatory requirements.

For manufacturers and distributors, the key question is therefore no longer simply:

“Can we sell this product in Türkiye?”

It is also:

“Can we sell and promote it through our chosen channel in compliance with Turkish requirements?”

What This Means for Market Access

Türkiye’s latest regulatory development reinforces the need for companies to approach market access from a full regulatory lifecycle perspective.

For medical-device businesses, the journey may involve:

Product Registration → Distribution → Sales Channel → Promotion → Consumer Communication → Ongoing Compliance

Companies that assess only the registration stage may overlook requirements that apply further along the commercial pathway.

This is particularly important for international manufacturers working with local distributors, opticians or digital platforms.

Clear allocation of regulatory responsibilities between the manufacturer and local partners can help reduce compliance gaps as products move from registration into commercialisation.

Key Takeaway

Türkiye introduced an amendment to its Medical Device Sales, Advertising and Promotion Regulation on 3 July 2026, introducing specific requirements for the online sale of contact lenses.

The amendment requires online contact-lens sales to consumers to take place through an authorised website and through an optician’s establishment on a prescription basis, while also providing for potential delegation of website-approval authority to provincial health directorates.

For medical-device companies, the update is a reminder that successful market access involves more than obtaining a product licence.

The regulatory journey continues from registration to sales, promotion and ongoing compliance.

Stay Ahead. Stay Compliant. Stay Informed.

With ARQon Regulatory Intelligence.