What do you need to know about the certification of medical devices in Ukraine?

Registration of medical devices is a mandatory procedure that ensures that the products meet the established safety and efficacy requirements before they are put on the market. This article will help you to understand the key aspects of the medical device registration process in Ukraine, including the legal requirements, stages and documents required to successfully complete the procedure.

What is a medical device?

A medical device is any device, apparatus, material or other product used to diagnose, treat or prevent diseases, maintain vital functions or compensate for physical disabilities.

In Ukraine, medical devices are classified by risk level into:

● Class I (low risk);

● Class IIa and IIb (medium risk)

● Class III (high risk).

Why do you need to register medical devices?

It is required to put medical devices and medical devices for in vitro diagnostics on the market. This is a rather complicated procedure, and in order to avoid mistakes during registration, you need the assistance of NVsert specialists.

Registration of medical devices allows:

1. Ensure compliance of products with international standards.

2. Ensure the safety of patients and users.

3. To legally put the product on sale and use on the territory of Ukraine.

4. To ensure the competitiveness of products on the market.

Legal basis for registration of medical devices

Registration of medical devices in Ukraine is regulated by:

1. Technical regulations:

✔ CMU Resolution No. 753 dated 02.10.2013 - for general medical devices;

✔ CMU Resolution No. 754 dated 02.10.2013 - for active medical devices that are implanted;

✔ CMU Resolution No. 755 dated 02.10.2013 - for medical devices for in vitro diagnostics.

2. The Law of Ukraine ‘On Technical Regulations and Conformity Assessment’ (No. 124-VIII of 15.01.2015).

3. International standards:

✔ ISO 13485 - quality management systems for medical device manufacturers;

✔ ISO 14971 - risk management.

Stages of registration of medical devices

1. Classification of the product.

Determination of the risk class in accordance with the requirements of the Technical Regulations.

2. Preparation of the technical file.

It includes:

✔ product description;

✔ technical characteristics;

✔ test results;

✔ data on materials and components.

3. Conformity assessment.

Depending on the risk class, the procedure may include:

✔ self-declaration of conformity (for class I);

✔ involvement of a conformity assessment body (for classes IIa, IIb and III).

4. Clinical evaluation.

Analysis of clinical data to confirm the safety and efficacy of the product.

5. CE marking (if necessary).

For export to the EU, the product must comply with Regulation (EU) 2017/745 (MDR).

6. Obtaining a certificate of conformity.

The document confirms that the product meets the requirements of the Technical Regulations.

Documents required for registration of medical devices

✔ Application for registration;

✔ Technical documentation;

✔ Clinical report or test results;

✔ Instructions for use and labelling;

✔ ISO 13485 certificate (if available);

✔ Other documents depending on the class of the product.

Peculiarities of registration of imported medical devices

To import medical devices into Ukraine, it is necessary to:

1. Determine whether the product is registered in the EU market.

2. Submit an application for conformity assessment in accordance with the Technical Regulations of Ukraine.

3. Obtain a certificate of conformity.

Why choose Consulting Service Plus?

CSPlus offers a comprehensive approach to the registration of medical devices:

✔ Expert support. We know all the nuances of the registration process in accordance with the current legislation.

✔ Risk minimisation. We help to avoid delays and errors in the documentation.

✔ Saving time. Thanks to the experience of our team, the registration procedure is faster.

✔ Guaranteed results. We ensure the successful completion of your product registration.

Registration of medical devices in Ukraine is a necessary step for the legal introduction of products into circulation. Compliance with legal requirements and involvement of professionals, such as Consulting Service Plus, will help make this process quick and efficient.

Contact us today to learn more about registering your products!

Advantages of working with us

Reliability

Professional experience of the company with a team of highly qualified specialists in their field. We combine our knowledge and experience, use connections and contacts in the field of medical products certification since 2003.

Work without intermediaries

Our specialists are directly involved in the preparation of all documents and interaction with the relevant state authorities.

Guarantees

We guarantee the result of timely provision of services and cost. Compliance with the principles of confidentiality when working with clients. Rich experience allows us to solve problems and find solutions in any situation.

Short terms of work execution

Prompt execution of documents.
We control the timing of work and the correctness of documents at all stages. An integrated approach.

2003

Year of foundation

420

Regular customers

35

International partners

Our clients

We offer a whole range of services that allows you to minimize financial costs and terms of self-declaration:

✔ We compile a list of necessary documents from the relevant Technical Regulations.

✔ We carry out examination of documentation.

✔ Developing a bilingual (Ukrainian-English) Agreement on Authorized Representative in Ukraine.

✔ We translate the necessary documents.

✔ We compile the Technical file in accordance with the requirements of the Technical Regulations.

✔ We conduct clinical trials, specialized evaluation of clinical data.

✔ We organize letters for customs authorities with confirmation of belonging to medical devices.

✔ We are developing a labeling project.

✔ We draw up a Declaration of compliance with the requirements of Technical Regulations.

✔ Submit to the State Service a copy of the Agreement from the manufacturer for an authorized representative, a copy of the Declaration, an information letter, send an electronic form.

Answers to frequently asked questions

What documents are required for certification?

The list of documents submitted for the assessment of conformity to the requirements of the Technical Regulations.
✔ Power of attorney of the manufacturer to the authorized representative
✔ List of medical devices for conformity assessment
✔ Certificates of conformity of the manufacturer:

1. Certificate of compliance of the quality system with the requirements of EN ISO 13485.
2. Technical file on MV.
3. Product description.
5. Product classification.
6. Specification for the product.
7. Specification for materials and components.
8. Labels (primary and secondary packaging).
9. List of applicable standards.
10. Risk analysis.
11. Confirmation of compliance with the basic requirements ("checklist").
12. Process diagrams.
13. Information on packaging.
14. Confirmation of conformity of measurement accuracy (if applicable).
15. Declaration of conformity of the MV with the requirements of the Directive.
16. Instructions for use of MV.
17. Report on preclinical studies (evaluation).
18. Report on clinical trials.
19. Quality guidelines.

Validity of certificates?

Conformity assessment with the involvement of the authorized body provides a choice of two options:
By assessing the quality management system of the production site (inspection), resulting in the issuance of a certificate of conformity assessment for a medical device for a period of 5 years, associated with a certificate for a quality management system for a period of 3 years. By batch conformity assessment, which provides for the issuance of a certificate for a specific batch (supply) of medical devices as a result of examination of documentation and testing of product samples.

What is the difference between registration and certification?

Medical products, that have undergone state registration, are included into the state register of medical equipment and medical products and is approved for use on the territory of Ukraine, the validity of the certificate on state registration of which is restricted or ends after July 1, 2015 – it is possible to deliver on the registration certificate until 01 July, 2017. Product certification is the conformity process of product quality standards, established by the legislation requirements in Ukraine. Certification is carried by specifically accredited organizations. Supporting documents are issued on the results of certification – certificates of conformity, declaration of conformity.

What are the stages of the certification procedure?

To obtain a certificate of conformity assessment for a period of 5 years it is necessary to:

✔ Obtain an authorized representative of the manufacturer in Ukraine, to perform all related legal formalities.
✔ Choose a combination of procedures, according to class, manufacturer’s documentation, and other factors.
✔ • Form a technical file as required by the relevant regulations; prepare the application form and a check-list.
✔ Select the authorized body for conformity assessment and to apply, pay for the work of the authority.
✔ Undergo the documentation expertise procedure to respond to the comments. Finalize the object, date and plan of the inspection.
✔ Organize inspectors visit on production.
✔ Eliminate the comments received as a result of the inspection.
✔ Get a decree of the regulatory body on the quality management system of the production site.
✔ Get a certificate of conformity assessment of the medical product requirements of the Technical Regulations.
✔ Issue a declaration of conformity with the Technical Regulations.
✔ Apply conformity mark and the identification number of the regulatory body to the labeling of the medical product; make sure that the other requirements for labeling and instructions (user manual) comply with the requirements of the Technical Regulations and the currents legislation.

What you get after all the certification procedures?

Declaration of conformity replaces the registration certificate at the customs clearance of medical products.

Is there a specific list of medical devices subject to mandatory certification?

There is no such list as a separate document. However, technical regulations divide medical devices into classes according to the level of potential risk to the patient. According to the class, some medical devices are subject to a mandatory self-declaration procedure, and the rest are subject to the requirements for involvement of the designated conformity assessment bodies in conformity assessment for placing on the market in Ukraine.