Esin / Healthcare & Life Sciences Newsletter - November 2023

Announcement on the Products Not Considered Within the Scope of Medical Device Regulations

On 30 October 2023, the TİTCK published the Announcement on the Products Not Considered Within the Scope of Medical Device Regulations. In this regard, products that are placed on the market for general use without any medical purpose by the manufacturer are not considered within the scope of the Medical Device Regulation or In Vitro Diagnostic Medical Device Regulation (collectively “Medical Device Regulations”). However, products that are placed on the market with a health declaration by the manufacturer for medical purposes and that show their impact in line with the mechanism of action expressed in the definition of medical device are considered within the scope of the Medical Device Regulations. In addition, for products that have the same production technology and are placed on the market with the same design, a distinction is made as to whether they are within the scope of the Medical Device Regulations based on their intended use, place of use, method and form of use.

The Announcement provides detailed examples of products that do not fall under the definition of medical device or in vitro diagnostic device in the Medical Device Regulations. Some examples are as follows: i) patient and baby armbands, ii) examination screens or curtains, iii) radiation protective screens, iv) eskabos, v) wipes used for cleaning the injection site and removing the biological load in the area, vi) teeth whitening products (pastes, gels, irradiation devices, etc.), vii) suncream, viii) devices used in the manufacture of pharmaceuticals, medical devices, cosmetic products or biocidal products (distilled water devices, mixers, pharmaceutical compounders, etc.), and ix) masks, gloves, work clothes, overalls, etc. manufactured for personal use or protection.

These products, which will not be considered within the scope of the Medical Device Regulations, should not be placed on the market as medical devices and Product Tracking System (“ÜTS”) registration notifications should not be made.

The Announcement is available here (in Turkish).

Third Quarter Results of the Market Surveillance and Inspection of Cosmetics and Biocidal Products

On 13 November 2023, the TİTCK announced the results of its cosmetic sector market surveillance and inspection conducted in July, August and September 2023.

Of the 61 cosmetic products inspected by the TİTCK’s Cosmetics Supervision Department, 55 were noncompliant and 1 was risky. The responsible companies were subject to an overall administrative fine of TRY 214,050 (approximately USD 7,403).

Of the 22 type-1 and type-19 biocidal products inspected by the TİTCK’s Cosmetics Supervision Department, 7 were noncompliant and 6 were risky. The responsible companies were subject to an overall administrative fine of TRY 583,898 (approximately USD 20,193).

The 2023 third quarter results for cosmetic products are available here (in Turkish).

The type-1 and type-19 biocidal products’ 2023 third quarter results are available here (in Turkish).

What Do the Results Say?

The cosmetic products’ safety results reveal that both the number of inspected cosmetic products and the number of noncompliant products decreased when compared to the results of the second quarter of 2023. However, although there has been a decrease in the total amount of fines imposed, it is not parallel to the decrease in the number of inspected products.

The type-1 and type-19 biocidal products’ safety results reveal that the number of inspected and noncompliant products has increased. In this regard, there has been a significant increase in the number of fines imposed.

Guideline on the Procedures and Principles of Pharmacovigilance Activities Conducted by Contracted Pharmacovigilance Service Organizations and Marketing Authorization Holders

On 15 November 2023, the TİTCK updated the Guideline on the Procedures and Principles of Pharmacovigilance Activities Conducted by Contracted Pharmacovigilance Service Organizations and Marketing Authorization Holders. The main amendments introduced by this Guideline are as follows:

• The pharmacovigilance officer working for the pharmaceutical marketing authorization holder can be responsible for the pharmacovigilance activities of 150 active substances, and the pharmacovigilance officer working for the Contracted Pharmacovigilance Service Organization (“CPSO”) can be responsible for the pharmacovigilance activities of 100 active substances. The number of active substances for which the officers are responsible can be increased by a maximum of 10% of the upper limit.
• To work as a pharmacovigilance officer, it must be documented that at least one year of work in the field of pharmacovigilance is required.
• The obligation to record the entries into and exits from the CPSO’s physical archive using a fingerprint scanner system was removed. However, entries into and exits from the physical archive must be effectively monitored and recorded.
• The requirement for marketing authorization holders and the CPSOs to have an ISO 9001 Quality Management Certificate issued by a conformity assessment body authorized by TURKAK in the field of the ISO 9001 Quality Management Accreditation was removed.
• The CPSO’s obligation to provide quarterly 1-hour training sessions at least four times a year to personnel who may use the pharmacovigilance system or conduct pharmacovigilance has been removed. It is considered sufficient to only provide training sessions once a year.
• The provision regulating the minimum requirements for security databases to be maintained by marketing authorization holders and the CPSOs will enter into force on 1 July 2025, and the other provisions of the Guideline will enter into force on 1 January 2024.

The Guideline is available here (in Turkish).

Regulation on Private Hospitals

On 17 November 2023, the Ministry of Health published the Regulation Amending the Regulation on Private Hospitals. The main amendments introduced by this Regulation are as follows:

• Licensed and active private hospitals with fewer than 100 beds and a minimum of 33 specialist physicians are allowed to increase the number of beds to 100 if the closed area does not exceed 25,000 square meters.
• If licensed and active private hospitals willing to operate in a closed area over 25,000 square meters have a staff of clinician specialist physicians of twice the minimum number of specialist physicians, individually or by merger, they are allowed to use this area and increase the total number of beds to 100 if there are less than 100.
• Hospitals to be established by foundation universities must have a bed capacity that is at least equal to the number of beds required in a tertiary hospital, i.e. 250 beds or more, to ensure sufficient capacity.

The Regulation is available here (in Turkish).

Conclusion

The TİTCK continues to provide guidance for companies working in the healthcare industry. Companies must carefully review the TİTCK’s announcements and take necessary actions to ensure compliance.