Certification of medical devices

Certificate for medical devices is an official document that certifies the compliance of the object with safety requirements. The purpose of the inspection is to protect consumers from low-quality goods.

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Certification procedure for medical devices

Medical devices, according to the Ukrainian legislation, are devices, equipment, instruments, instruments, systems, complexes, devices, implants and supporting materials:

✔ diagnosis, treatment and prevention of diseases, monitoring of the patient's condition or alleviation of his condition;

✔ research, replacement or modification of the structure of tissues, organs or physiological processes;

✔ control of the fertilization process.

Medical devices registered in Ukraine are allowed to be put on the market without conformity assessment procedure until the expiry of the certificate (whichever comes first). The sale of medical devices is allowed until the expiration of the shelf life (but not more than 5 years).

For all new (unregistered) medical devices and medical equipment from July 1, 2015 - it is necessary to pass the assessment of compliance with the Technical Regulations.

In order to obtain a certificate for a medical device, it is necessary to undergo a certification procedure for medical devices. This procedure allows to confirm the quality and compliance with the standards of the certified products.

If we talk about the mandatory procedure, the following products undergo it:

✔ Medical devices Is (sterile), I with measuring functions, IIa, IIb, III classes, according to the Technical Regulations on Medical Devices (CMU No. 753);

✔ Reagents, calibrators and controls included in the List "A" and "B" of the Technical Regulations of medical devices for in-vitro diagnostics (PCMU No. 754), products for self-control;

✔ All medical devices that fall under the scope of the Technical Regulation on Active Implantable Medical Devices (CMU No. 755).

✔ For medical devices of the I class (non-sterile, without measuring functions), in accordance with the Technical Regulations on Medical Devices (CMU No. 753), in-vitro medical devices that are not included in the List "A" and "B" of the Technical Regulations (CMU No. 754), which are not intended for self-control - the self-declaration procedure is applied.

The result of the certification procedure is a conformity assessment certificate for a medical device associated with a certificate for the manufacturer's quality management system and a Declaration of Conformity with the requirements of the Technical Regulations.

Consulting Service Plus has been working in the medical equipment market for more than fourteen years, has the necessary knowledge and skills to carry out the full range of works on certification and self-declaration of medical devices.

We offer you cooperation in passing the approved conformity assessment procedures: Technical regulations

(Resolution of the Cabinet of Ministers of Ukraine №753 dated 02.10.2013),

Technical regulations (Resolution of the Cabinet of Ministers of Ukraine No. 754 dated 02.10.2013),

Technical regulations (Resolution of the Cabinet of Ministers of Ukraine №755 dated 02.10.2013).

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

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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.

Certification of medical devices

Certification procedure for medical devices

For all new (unregistered) medical devices and medical equipment from July 1, 2015 - it is necessary to pass the assessment of compliance with the Technical Regulations.

If we talk about the mandatory procedure, the following products undergo it:

The result of the certification procedure is a conformity assessment certificate for a medical device associated with a certificate for the manufacturer's quality management system and a Declaration of Conformity with the requirements of the Technical Regulations.