Technical file of the manufacturer
The company "Consulting Service Plus" offers services for registration of technical documentation for an authorized representative.
Send a requestThe procedure of registration of the Technical file of the manufacturer:
Technical file is a set of documentation submitted to the conformity assessment body for the conformity assessment procedure. It should contain the documents necessary both for identification of the assessed product and for confirmation of compliance with the requirements of the technical regulations for these products by their manufacturer.
The formation of the Technical file is a responsible task entrusted to the party initiating the conformity assessment procedure. The minimum required composition of documents included in the Technical file is determined by the Technical Regulations. In this case, the conformity assessment body may require the applicant to provide additional documentation.
Before submitting the Technical file to the chosen conformity assessment body, it is necessary to make sure that this document not only allows to conduct the conformity assessment procedure, but also meets the requirements of the national legislation of the country where the medical device is put into circulation.
The procedure for obtaining the Technical Specifications file:
Technical specifications are a technical document that is developed by the decision of the developer (manufacturer) or at the request of the customer (consumer) of the product. Technical specifications are an integral part of the set of design or other technical documentation for products, and in the absence of documentation should contain a full range of requirements for products, their manufacture, control and acceptance.
The composition, construction and design of technical specifications must meet the requirements of DSTU, GOSTs and other regulatory documents in force in Ukraine.
Example of designation of technical conditions: TU U 22.2-24993721-001: 2010, where 22.2 is the DKPP code, 24993721 is the OKPO code.
According to the standards in force in Ukraine, technical specifications should contain an introductory part and sections located in the following sequence:
- technical requirements;
- safety requirements;
- environmental protection requirements, disposal;
- rules of acceptance;
- control methods;
- transportation and storage;
- instructions for use;
- manufacturer's warranties.
Technical specifications may be a regulatory document for compliance with which product certification and obtaining a certificate of conformity is carried out.
High professionalism of our employees and long experience of the company in the field of registration and licensing of medical products allow us to find the best solution for the client in the field of costs and deadlines, because we have our own accredited centers, laboratories and hospitals. We will be glad to cooperate!
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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.
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Answers to frequently asked questions
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.
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.
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.
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.
Declaration of conformity replaces the registration certificate at the customs clearance of medical products.
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.