Amendments regarding the Regulation on Opticianry Institutions ("Regulation") have been published in the Official Gazette No. 31500 dated 3 June 2021 by the Turkish Medicine and Medical Devices Authority ("TITCK"). The Regulation which was introduced in the Official Gazette No. 28886 on 18 January 2014, covers the activities of those authorized to practice as opticians, the owners and operators of opticianry establishments, and the activities of opticianry institutions. You can read the Regulation on the Amendment of the Regulation on Opticianry Institutions ("Amendment") here. (Available in Turkish only)
What has Changed?
It is fair to say that there are significant changes in the Amendment. Those changes impact the implementation of the Regulation, opticianry institutions and their activities, and those qualified to work as opticians.
Here are some of the important changes described in the Amendment.
a. The Legal Basis of the Regulation Has Been Changed
First of all, the legal basis of the Regulation has been amended. According to Article 1 of the Regulation, Article 40 of Decree-Law No. 663 on the Organization and Duties of the Ministry of Health and its Affiliates is no longer the basis of the Regulation on Opticianry Institutions. Instead, it is now based on Articles 508 and 796 of the Presidential Decree on the Organization of Ministries, Associated, Related Institutions and Organizations, and Other Institutions and Organizations No. 4 published in the Official Gazette No. 30479.
b. Documents for License Applications Have Been Amended
Article 2 of the Amendment regulates license applications and documents. In the second paragraph of the article, the information and documents required to be included with an application file attached to an application petition are listed. With the amendment,
- It is stipulated that if the owner is a real person who does not have the right and authority to practice as an optician, the TR identity number or foreign identity number of the owner of the institution and of the qualified person should be included with a license application file.
- Additionally, it is designated that the relevant optician-spectacles chamber member registration certificate of the qualified person should be included in a license application file attached to the application petition.
c. Identification Cards Have Been Introduced
Article 8 of the Regulation deals with the evaluation of applications. After the evaluation which is proceeded in accordance with paragraph 4 of the Article, the provincial directorate will issue an identification card to the applicant on behalf of the qualified person. The sample of the identification card is attached in the Annex-7 of the Amendment.
Furthermore, it has been added in paragraph 5 that if someone other than the qualified person is employed in the institution, an identification card will be issued on behalf of the personnel in addition to the personnel work document.
d. The Registration System for Optical Products Has Been Modified in Terms of Prohibitions
A change has been made to paragraph (j) of Article 25 of the Regulation setting prohibitions. According to this, instead of prohibiting the sale of optical products that are not registered with the Turkish Medicines and Medical Devices National Data Bank, it has been ruled that sales of medical devices that are not in TITCK's registration and information management system are prohibited.
e. Various Activities of Opticianry Institutions and Their Sanctions Have Been Linked to the Medical Device Sales, Advertising and Promotion Regulation
Article 24 regulates the promotion and advertising of opticianry institutions. In this regard, for medical devices supplied to the market or made available by optician institutions by means of remote communication tools; trade, advertising, information, clinical support, promotional activities, registration procedures and information management systems determined by the institution, should be carried out in accordance with the Medical Device Sales, Advertisement and Promotion Regulation published in the Official Gazette dated 15 May 2014 and numbered 29001.
On the other hand, as a result of paragraph 4 that has been added to Article 27 of the Regulation, which regulates sanctions against institutions found in violation of the Law on Opticians numbered 5193 and the Regulation, any breach of the provisions above-mentioned will bring about the same sanctions with the Medical Device Sales, Advertisement and Promotion Regulation.
Additionally, it has been regulated that the sanctions specified in the Medical Device Sales, Advertisement, and Promotion Regulation will be applied in the same way for both the opticianry institution and their qualified person in cases of violations regarding the same transactions.
Thus, in addition to institutional responsibilities, issues relating to placing or keeping devices on the market, information management system registration, up-to-date and traceable information, working order, and inspections may give rise to TITCK sanctions for institutions regarding qualified persons including:
- Issuing a "Warning"
- Cancelling an employment certificate / no new document issuance for one year.
Conclusion
The aim of the Regulation is to protect the health of individuals and society by means of regulating procedures and principles regarding the use of the title of optician, the practice of the profession of optician, the establishment of opticianry institutions, and their promotion and advertising.
In this amendment, TITCK, in compliance with the general approach of updated EU medical device regulations, stipulates that the various activities of opticianry institutions and their related sanctions for both opticianry institutions and their qualified person will be applied corresponding to the Medical Device Sales, Advertisement and Promotion Regulation.
Accordingly, it is strongly recommended that both opticianry institutions and their qualified person carefully examine the Medical Device Sales, Advertisement and Promotion Regulation and ensure that their activities comply with it.
This news alert concerns the domestic and international medical device companies operating in the field of optics.
With thanks to Ayse Gonen Anaeli and Nida Nur Yilmaz for their assistance on this article.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.