1.What happened to medical devices registration after 1.07.2015?
2.I have Certificate of registration for medical device, do I need to pass compliance assessment?
3.What shall one do if the validity of the Certificate of registration of the medical device has been expired?
4. It is just now that I am about to supply medical products to the market, consequently, I do not have Certificate of registration of the medical device. What shall I do?
5.What is the term, the Declaration/ Certificate of assessment of compliance with Technical Regulations is issued for?
6. Shall auditors visit the production site? If so, then when?
7. What is the periodicity of auditor’s visits to the production site within the period of the Certificate validity?
8. Is it needed to submit product samples? If so, in what cases it shall be done?
9.What is the cost of passing the procedure of compliance for medical devices?
10. How REGCONSULT Company may help the medical device manufacturer?
Since July 2015 the rules for the Ukrainian market of medical devices have been changed. State registration of themedical device is annulated, and, instead, manufacturers and importers must pass the procedure of assessment of compliance with the Technical Regulations. Practice has proven that even the tiniest change in long-standing rules usually raise a lot of questions from all market players – so this conclusion applies not only to the market of medical products. To make life of importers and foreign manufacturers of medical products easier, we have collected the most frequently asked questions by manufacturers and medical devices suppliers – and given detailed and comprehensive answers on them.
In short, the registration is canceled. Let us explain it in more detail: pursuant to Resolution of the Cabinet of Ministers of Ukraine No. 215 of 01.07.2014, the State registration of medical device is abolished from 1.07.2015 and the procedure of assessment of compliance of medical devices with the Technical regulations comes into effect. Therefore, the principal authorization document for import and production of medical devices in Ukraine is the compliance assessment instead of the Certificate of registration.
That is, medical devices manufacturers and importers, that for the first time make a market launch of goods, must pass the procedure of assessment of compliance with the Technical Regulations instead of getting the Certificate of registration. Successful passing of the procedure shall be confirmed by the issuance of the Declaration/Certificate of compliance with the Technical Regulation and then the applicant gets the right to mark the packing of medical products with the national sign of compliance.
We recommend, at the least, to think about the initiation of the procedure of compliance assessment. Even though the medical products with an unexpired validity of the Certificate of registration have right to freely circulate at the market – till 1.07.2017
– this will happen in a shorter period of time. Moreover, if the Certificate of registration of the medicl device expires prior to July 1, 2017, it is not subject to re-registration, and it will be necessary to substitute it by the Certificate of assessment of compliance with the Technical Regulations.
Let us remind that pursuant to Resolution of the Cabinet of Ministers of Ukraine No. 181 of May 27, 2014, medical products with Certificate of registration may be commercialized and used at the territory of Ukraine within the transition period:
— till July 1, 2016 — for medical products, whose Certificates of registration do not have expiry dates or expire after July 1, 2016;
— till the expiry date of the Certificate of State registration — for medical products, whose Certificates of State registration expire before July 1, 2016.
Health products with expired shelf-life are subject to disposal. The same procedure is provided for the Certificates of registration of medical devices that have been expired. Since 1.07.2015 any prolongation of validity of such Certificate (re-registration) is abolished. For further circulation of these medical products at the Ukrainian market the manufacturer has to pass the procedure of assessment of compliance of these medical products with the Technical Regulations.
— Since July 1, 2015 medical products launched for the first time in the Ukrainian market, must not undergo the registration procedure and receive Certificate of registration of the medical device. The procedure of registration is substituted by the assessment of compliance with the Technical regulations, and the Declaration/Certificate of compliance with the Technical regulations is needed instead of Certificate of registration. Therefore, to legally put into service and supply new kinds/types/marks of medical products to Ukraine it is necessary to receive the Declaration of compliance from the manufacturer and pass the assessment of compliance with the Technical Regulations by the certified authority.
Pursuant to art. 24 of the “Technical regulation for medical products”, the validity of the Certificate of assessment of compliance with the Technical Regulations shall not exceed 5 years. However, this period of validity may be prorogated for the next 5 years — in this case the respective applications shall be submitted to the certification authority. Note that the term for application shall be obligatory, indicated in the Contract, and concluded between the certification authority and the applicant.
The Declaration of compliance of the medical device with the Technical Regulations shall be issued by the manufacturer and it is valid for an indefinite period. However, in case of any changes (in construction, production process, etc.) the manufacturer must issue a new Declaration of compliance of the medical device with the Technical Regulations.
The necessity for auditors to visit the production site where medical device is manufactured is determined by the class of medical products and the chosen procedure of verification of their compliance with the Technical Regulations. Briefly, the variants of answers to this question may be as follows:
The procedure of assessment of compliance with the Technical regulations provides for an annual supervised audit. It means that within the term of the Certificate validity auditors shall make at least 1 visit to the medical device production site.
In addition, auditors have the right to carry out non-scheduled inspections at the production site without previous notification of the manufacturer or his authorized representative of it.
Product samples shall be submitted in cases when the chosen procedure provides for testing the product.
It is impossible to give a clear answer to this question, because the level of expenditures related to the procedure depends on many parameters. In particular, it depends on manufacturer’s documentation, selected scheme of compliance assessment, class and type of products, number of batches to be delivered to the market, production process, number of personnel involved in production process, etc. For this reason, the cost of passing the procedure of compliance for medical devices may be calculated upon submission of all initial data.
If you are a foreign manufacturer of medical products and desire to supply your products to Ukraine, REGCONSULT may become your authorized representative in Ukraine. Let us remind you that the pursuant to Law of Ukraine “On Technical Regulations and Conformity Assessment», dated 15.01.2015 № 124-XIX the procedure of assessment of compliance of medical products manufactured outside Ukraine shall be initiated by Ukrainian representatives of foreign manufacturers of medical equipment.
If you are a Ukrainian manufacturer of medical products and desire to pass the procedure of assessment of compliance with the Technical Regulations, REGCONSULT employees will give you consultations on correct choice of the procedure of compliance assessment, help to form a needed package of documents and organize passing the procedure as quick as possible.
If you are an importer of medical products REGCONSULT employees may assist in a one-time import of medical products and supervise the whole process of one-time import of medical products.
Call this telephone number +380442233218 to get answers to questions concerning the assessment of compliance of medical products with the Technical Regulations.
Contact REGCONSULT by email: firstname.lastname@example.org
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