Medical Devices Registration

REGISTRATION OF THE MEDICAL DEVICES TO THE PRODUCT NOTIFICATION SYSTEM

Medical device: It refers to medical device description under articles entitled “definitions” of  Medical Devices Regulations published in official newspaper dated 7/6/2011 and numbered 27957  and Active Implantable Medical Devices Regulations published in the official newspaper dated 7/6/2011 and numbered  27957.

1) Diagnosis, prevention, monitoring, treatment or mitigation of the disease or

2) Diagnosis, monitoring, treatment, mitigation or elimination of victimization of injury or disability, or

3) Investigation, modification or replacement of an anatomical or physiological function, or

4) Birth control.

All kinds of tools, devices, equipment, software, accessories or other materials, including software manufactured by its manufacturer specifically for diagnostic and/or therapeutic use and necessary for the purpose of performing the intended function of the medical device and when used in humans, that does not provide its essential function with pharmacological, immunological or metabolic effects, but can be supported by these effects while performing its function and manufactured for following purposes on human beings;

From 12/06/2017,  with the authority dated 02/06/2017 and numbered E.1967 with the opening of the Product Tracking System (UTS) Medical Device Registration Screens, Registration of medical devices and related documents, which are placed on the market within the scope of Medical Device Regulations, is carried out through product notification system (UTS).

In this context, as PIM Group, we provide all kinds of necessary services. You can find some of these services in detail below.

HOW TO REGISTER A MEDICAL DEVICE COMPANY

UTS registration of medical device sales and/or application companies (medical device sales center, manufacturer/importer, institution Optometry, Hearing Center, bespoke prosthetics-orthotics Center, pharmacies, pharmaceutical wholesalers, etc.) is carried out if they are authorized by the relevant legislation. Company registrations are carried out from MERSIS or VEDOP. If a company has both a MERSIS and a VEDOP number, registrations are made through the MERSIS system. Company registrations of pharmacies are carried out through the ESY system.

HOW ARE MEDICAL DEVICE DOCUMENT REGISTRATION PROCEDURES PERFORMED?

After the company has been approved, medical device document registry will be made by uploading the following documents to the system from 01/03/2019.

1. EC Vertification

2. Declaration of Conformity

3. User Manual

4. Quality Management System (ISO-13485)

5. Certificate of Domestic Goods

6. Authorized Distributorship Certificate

7. In medical device registration, the current label and sales packaging template must be loaded in the “original label” section in the technical file of the medical device.

HOW TO REGISTER A MEDICAL DEVICE PRODUCT   

Once the documents have been approved, each released medical device must be registered in the UTS portal.

Some of the information that needs to be entered into the UTS portal is as follows.

1. Product number

2. Brand

3. Product Name

4. Version/Model

5. Product Reference / Catalog Code

6. Product Description

7. Number of products in content

8. Import / Manufacture Information

9. Country of origin information

10. Regulation and class information

11. GMDN code and branch type

12. Product Images

13. Label

TECHNICAL FILE CONTENTS OF MEDICAL DEVICES

The technical file should be stored for ten years. Technical File Content documents must be in Turkish. The contents of the Technical File are delivered via EBS, not UTS.

The contents of the file are as follows.

1. Device description and specifications

2. Information to be provided by the manufacturer

3. Design and manufacturing information

4. General safety and performance requirements

5. Benefit-risk analysis and risk management

6. Product verification and validation