Product Registration

Company «Orlando Ltd» provides services associated with registration of medical products in Ukraine.

Our employees efficiently and quickly help to get all the necessary documents for license to sell medical products in Ukraine.

«Orlando Ltd»  provides following services:

- Registration / reregistration of cosmetics and personal care products

- Registration / reregistration of medical devices

- Registration / reregistration of dietary supplements

- Development, approval and registration of technical specifications (TS )

We are highly qualified multi-speciality team of experts who will accompany the registration process from the beginning to obtainment of the certificate. Our employees have long-term experience of work providing high quality of preparing package of necessary documents, allowing speed up the process of obtaining the certificate and solve controversial issues with state bodies.

The cost of our services includes all necessary expenses for registration including government fees and charges and examination of documents and testing product quality in the laboratory.

Where to start? The algorithm of cooperation:

You contact us by phone +38 (067) 549 36 55, via e-mail: info@orlandoltd.com.ua or we are glad to meet you in our office.

Pre-registration examination of dossier. We review the primary information (list of products, composition, recommendations for use). Then, you send us copies of documents by e-mail, after checking and approving them you send us originals of documents in paper format and samples of the finished product (for laboratory analysis).

We make Contract for registration service with you.

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We work out the project of Application and send it to you for approval.

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Formation of dossier. All documents and materials for cosmetics will be formed in dossier according to Ukrainian legislation. If necessary dossier documents can be translated. In order to present your interests in the expert institutions we need The power of attorney.

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Specialized expertise of documentation and laboratory analysis of samples. Documents shall be submitted to the expert body of sanitary- epidemiological service of Ukrainian MOH.

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Proofreading of conclusion project. As a result of the positive conclusion of documents examination – the conclusion project is issued. The project is agreed with customer as well.

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Receiving the original document of registration and transfer to the customer. Work completion time depends on the type of medical product and specified in each web-site section.

Registration of cosmetics and oral hygiene preparations

is registration of products which are intended for the care of human appearance and ensure personal hygiene. For the import and sales of cosmetics in Ukraine you should receive sanitary-epidemiological conclusion confirming the quality and safety of products.

Issue of conclusion is based on:

- Results of documents examination

- Laboratory analysis of product samples.

The issue of these conclusions is realized by expert institutions of sanitary-epidemiological service of the Ministry of Health of Ukraine. Sanitary-epidemiological conclusion is issued for a period from 2 to 5 years.

List of documents and materials to apply to the institutions of state registration of cosmetic products in Ukraine:

Power of attorney

The manufacturer certificate of incorporation as a legal entity

Quality certificate of manufactory: ISO 9001, GMP and others

Free sale certificate or Export certificate

Composition of finished product (ingredients and its quantities)

Specification of finished product (physicochemical characteristics)

Declaration letters (on the company letterhead): absence of GMOs, toxicological control

Scientific data: dermatological, toxicological, clinical trials and safety assessment

Exterior of package: photo or picture of labels

Product samples: 4 packages

Operation period is 45 days from the date of applying registration materials to the Ministry of Health of Ukraine.

Registration / reregistration of medical devices

The procedure of state registration of medical devices is regulated by Resolution of Cabinet of Ministers of Ukraine from 09.11.2004 № 1497 “About procedure approval of state registration of medical equipment and medical devices” (as amended and supplemented).

According to the law, medical devices are devices, complexes, systems, equipment, apparatus, instruments, implants, supplies, materials or other products including invasive medical devices; medical devices for in vitro diagnostics; medical devices that do not reach the main suspected target in the human body or on it using pharmacological, immunological or metabolic means but whose functions such products can contribute; medical devices that are used both individually and in combination with each other, including the software tools required for their adequate use in order to ensure:

  • prevention, diagnosis, treatment, monitoring or relief of the patient in case of illness, injury, disability or compensation;
  • investigation, replacement or modification of the structure (anatomy) of organs, tissues or physiological processes;
  • control of fertilization process;

State registration of medical devices is carried out by the State Service on Medicines of Ukraine based on the results of examination and research carried out by expert institutions.

Medical devices manufactured in Ukraine or imported ones (according to the list determined by the MOH) are liable for state registration.

List of medical devices  (see on http://www.med-registration.com.ua/rus/page/medicinal_devices_registration) that are liable for registration (reregistration) in Ukraine, according to Decree of Ukrainian MOH № 478 from 02.07.2012.

State registration of medical devices is based on the application and corresponding package of documents submitted to State Service on Medicines by the applicant who is responsible for production, safety, quality and effectiveness of medical devices.

List of documents for registration of medical devices:

  1. Numbered list of documents and materials submitted for registration.
  2. Application in the established standard form from the manufacturer or its representative (supplier, developer, importer, etc.). If the applicant is not the manufacturer of medical device he also submit a document confirming his authority for registration on behalf of the manufacturer indicating the receiver of State Registration Certificate and its owner (agreement, power of attorney, etc.).
  3. List of medical devices (in electronic format) submitted for registration with catalog numbers (in original language and Ukrainian).
  4. Brochures, catalogues of medical devices.
  5. Operation manual, technical passport.
  6. Certificates:
  • Certificate of manufacturer;
  • Certificate of origin;
  • Foreign documents (national or international) confirming compliance of medical devices with requirements of national or international regulations and describing conditions of its production (if available).
  1. Certificate of conformity for products issued in accordance with the laws of Ukraine (if available).
  2. Information about the standards, normative bases on the basis of which medical devices are manufactured (if available).
  3. Conclusion by results of state metrological attestation – for measuring devices.
  4. Reports of testing the quality, safety and efficacy of medical device (if available).
  5. The label or marking sample of medical device.
  6. Documents of manufacturer registration in its country legalized in a proper way.
  7. Copy of registration certificate of the applicant, if applicant is the business entity in Ukraine.
  8. Technical passport.
  9. Documents (national or international) confirming the adequacy of the product to requirements of national or international regulatory standards and describing the production conditions.
  10. Certificate of conformity of production to Ukrainian legislation (if production in Ukraine).
  11. Reports based on studies of safety, quality and efficacy of the product.
  12. Documents confirming the state registration in the country of manufacturer legalized by a notary and apostilled.

Volume and content of expertise (studies) depend on the potential risk of medical device use in medical practice. There are established four safety classes: I, IIа, IIb and III. Safety class of medical devices is declared by the applicant and confirmed by the results of technical expertise.

Based on decision of state registration medical products are included in the State Register of medical equipment and medical devices which is conducted by State Service on Medicines and the applicant obtains certificate of state registration of medical devices. The certificate can have annexes which contain the modification of medical devices and components.

Свидетельство ИМН 1Свидетельство ИМН 2Свидетельство ИМН 3

 

State registration certificate of medical device in Ukraine contains such information:

  • Registration certificate number;
  • Date of issuing the certificate;
  • Device name;
  • Safety class (I, IIa, IIb or III);
  • Name and address of manufacturer(s);
  • Validity of certificate (for testimonies issued after 20.06.2012 used indication that the validity is unlimited);
  • Annex to the Certificate with the list of modifications, components, consumables.

Registration certificate contains two annexes;

Annex 1 (modifications of the main product) includes a large number of products that have the same or similar principle and method of action and has the same safety class.

Annex 2 contains all consumables, components, spare parts and other products that are supplied together with the registered product.

Validity of certificates issued after 20.06.2012 is unlimited.

The total term of medical device registration is about 2 months.

Registration /reregistration of dietary supplements

- According to Ukrainian legislation (Resolution of Cabinet of Ministers of Ukraine №942 from 23.08.2004) all bioactive supplements imported into Ukrainian territory should pass state registration under “Procedure for state registration (reregistration) of bioactive supplements”.

Procedure of dietary supplement takes on average about 2-3 months after submitting the dossier.

The registration certificate is valid for 5 years from the date of issue. Upon expiration of registration the product can pass reregistration for renewal of registration certificate.

Documents for registration of dietary supplement:

1. Product samples.

2. Instructions and recommendations for use.

3. Specification (information about composition of the product and identification of components).

4. Documents from the country of origin confirming the quality, safety and efficacy of the product (certificates, etc.).

5. Normative and technical documentation of production process technology.

6.Information of registration in the manufacturing country.

7. Scientific reports, study protocols and other information confirming product safety.

8. Information with clinical trials.

9. Veterinary or Quarantine confirmation (if necessary).

10.Product code according to UCCFEA (issued by the Chamber of Commerce in Ukraine).

11. Contract of supply to Ukraine.

12. Power of attorney for registration.

13. Sanitary-hygienic conclusion of product issued by Ukrainian MOH.

Development, approval and registration of technical specifications (TS)

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Technical specifications (TS) is a document that establishes the technical requirements that must be met by particular product, material, substance, etc.

In addition there should be indicated the procedures by which possible to set compliance with these requirements.

Technical specifications are developed for one particular product, material, substance or several specific products, materials, substances, etc. (Then National Product Classifier code is specified on each product, material, etc.) Requirements specified in technical specifications should not contradict to mandatory requirements of state or interstate standards that are extended to these products.

Composition, structure and execution of technical specifications should meet the requirements of GOST, DSTU, GSTU, OST.

Development of Technical specifications is necessary in following cases:

  • There are no interstate or national standards of products;
  • Production does not meet current standard or other raw materials are used;
  • Finished products have better quality than described in the standard;
  • It is necessary to concretize, complete or increase the requirements of current standards for these products.

Technical specifications must be registered in various government agencies. List of agencies is determined depending on type of product for which technical specifications are developed. Technical specifications are not valid without registration.

Validation of technical specifications is 5 years.

Development of technical specifications (TS) requires:

  • List of manufactured products
  • Scope of application
  • Description of technological process
  • Materials used in the manufacture
  • Standard sizes for industrial products
  • Testing methods if they differ from state standards
  • Requisites of Technical specifications Owner
  • Requirements for packaging (materials and specifics)
  • Shelf life

 

The term of development, validation and registration of Technical specifications is 3 months.