Market requirements for medical devices

Medical devices are apparatus, devices, products, materials, systems, equipment, instruments, implants, accessories, gadgets and other products including non-invasive medical devices, devices for in-vitro diagnostics; devices use solely or as a system, including software that are used in medical practice for:

Prophylactic, diagnostic, treatment, observation or facilitation of the patient in the case of disease, injury, disability, disease prevention;
Study, replacement or modification of the structure (anatomy) of organs, tissue or physiological processes;
Control of the pregnancy process
Diagnostic of the diseases;
Healing, total or partial elimination of the symptoms and development of the disease, change or exchange of the anatomical or physiological condition of the harmed organism or its functions;

What is needed for import and sale of medical devices in Ukraine?
Obligatory requirement for import and sale of the medical devices in Ukraine is established state registration (marketing authorizaton).
Devices that can be used by consumers require sanitary-epidemiological conclusion.
Some medical devices additionally require cetification for compliance to national standards.
Specific medical devices can require additional specific approvals, for example - measuring devices (thermometers etc.) require metrological attestation.

Establishement of registration of medical devices does not require business license or any other specific requirements. Import and sale of medical devices is not a licensing business.

State registration (establishment of marketing authorization) is perfromed by Ministry of Health of Ukraine on results of specialized expertise of quality, safety and efficinecy of medical device. Registered medical device is included to the State registry of medical devices of Ukraine. Registration certificate for medical device is issued for 5 years and can be renewed before expiry.

Classification of the product as medical device is assigned not by definition of the medical device. List of products that are considered as medical devices and require state marketing authorization is adopted by Order of State Inspection of Ministry of Health of Ukraine No. 51 as of May 6, 2010 (text of the Order 51 in Ukrainian).

Procedure of marketing authorization of medical devices is performed by centralized procedure. State Agency of Medicinal and Narcotic Products of Ministry of Health of Ukraine has sole responsibility for marketing authorization of medical devices in Ukraine.
State Agency perfrom supervision and management functions, whereas expertise of registration materials and studies of the products are performed by list of authorized institutions.

There is no self-declaration process. CE-mark is not applicable in Ukraine. Presence of marketing authorizations in neighbour countries, in EU or US, in CIS or in Russia does not give admission or any other benefits.

Certificate of state registration of medical device in Ukraine contains following information:

Number of the registration certificate;
Date of issue of registration certificate;
Name of the medical device;
Safety class (I, IIa, IIb or III);
Custom commodity code;
Name(s) and address(es) of manufacturer(s);
Validity of registration certificate;
Annex to the certificate with list of modifications, accessories and disposables registered under that certificate;

Registration certificate can cover big list of products that have same of similar method and way of action (administration), manufactured under same quality management system, same safety class and custom commodity code. Such devices are listed in Annex 1 to the registration certificate.

All accessories, disposables, spare parts and other products supplied with medical device should be listed in the Annex 2 to the registration certificate.

Some medical devices have only Annex 1, other can have no Annexes at all.

Additionally Application for marketing authorization of medical device include information on Applicant (owner) of registration certificate. Marketing authorization certificate is object of property right and belongs to the legal entity that applied for registration. Applicant can be any legal entity, resident or non-resident of Ukraine, manufacturer itself.

Different medical devices have different characteristics:

Taxation: some medical devices are not object of VAT tax (20%);

State tenders: general group and devices that can be purchased by funds of state budget;

Types: general medical devices, medical devices for in-vitro diagnostics, active implants;

Safety class: I, IIa, IIb or III (definition of the safety class is similar to given in MDD 93/42/EEC);

Custom commodity code: classification by groups, type and method of administration of medical device;

Cratia offers full and overwhelming assistance in establishement of marketing authorization of medical devices in Ukraine and additionaly required procedures from the moment of first contact till receipt of certificates and approvals. We are team of professionals with years of experience, outstanding knowledge of legislation and great relations with state authorities.

We provide:

all necessary consulting regarding requirements for registration of specified products, structure or registration dossier, legal requirements, requirements for legalization of the documents, advices on custom commodity code, particularities of the registration process etc;
most professional pre-submission expertise of registration materials, filling Application and Annexes;
examples and forms of specific documents, internal guidelines on preparation of materials for marketing authorization in Ukraine;
translation of necessary documents, including notary certification; all translations are performed by our emploeyees that guarantee high professional and scientific leval of translated documents;
representation of your interest's in state authorities in all issues realated to registration expertise process;
if necessary - we handle process of import of samples; we have all necessary accredetation and licenses from customs;
maintanace of defficiency letters; we control all timing;
internal expertise of the draft of marketing authorization certificate with annexes;
receipt of marketing authorization certificate (certificate of state registration) with all annexes, notary certification of copy of documents and delivery by Courier to the Customer;

All preliminary consulting and advices are free of charge, do not hesitate to contact us by e-mail info@cratia.ua, tel. +38 (044) 332-42-94 or visit our office.

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