Registration"DOSTYK" LTD., WELCOMES YOU AND INVITES TO FRUITFUL COOPERATION AT THE HIGH PROFESSIONAL LEVEL!
We render a full spectrum of services in the field of the state registration/re-registration of medical technique and products of medical purpose, development of standards of the organization and operational documents.
Address us if:
- You prefer to be engaged in work, instead of red tape
- You have nobody to charge so responsible mission in your company or the budget of the company does not provide the maintenance of a department of experts
- You have no time to penetrate into the list of necessary documents, the current legislation and special terminology
High requirements to business dealing, the conclusive potential, the creative approach and the debugged work of the highly skilled personnel, the adjusted business ties with partners and the quality assurance of a rendered complex of services is the mortgage of successful activity of our company.
Our efforts are directed on acceleration of process of a conclusion to the Kazakhstan pharmaceutical market of qualitative production both domestic, and foreign manufacturers.
WE SINCERELY APPRECIATE AND WE JUSTIFY TRUST RENDERED TO THE COMPANY!
The Registration Certificate
Obligatory condition of import and realization of products of medical purpose and medical technique in Kazakhstan is their state registration. Procedure of the state registration is regulated with the Order of Minister of Health of Republic Kazakhstan from November, 18th, 2009 ¹735 «About the statement of the normative legal certificates regulating the state registration, a re-registration, modification in the registration file and examination of medical products, medical technique and products of medical purpose in Republic Kazakhstan».
The decision on registration/re-registration is accepted by Committee of the pharmaceutical control of Ministry of Health of Republic Kazakhstan on the basis of the conclusion which have been given out by the republican state enterprise
«The National center of examination of medical products, medical technique and products of medical purpose» (The republican state enterprise «The national center of examination of medical products»).
The state registration operates within 5 years after its termination for a turn in the Kazakhstan market medical technique and products of medical purpose are a subject to a re-registration.
The medical technique and the products of medical purpose registered and brought in the State register of medical products are released from the tax to the added cost (VAT).
Terms and cost of services on registration depend on a kind of registered production and completeness of the registration file.
If you were interested with services of our company in the field of the state registration of products of medical purpose and medical technique - on our site you can also:
Development Of Standard Of The Organization
The standard of the organization is the document establishing technical requirements with which should satisfy production, process or service. Except it in it should be specified the procedures by means of which it is possible to establish, whether observed the given requirements. Standards of the organization are developed on one concrete product, a material, substance or some concrete products, materials, substances, etc.
Having addressed us, you can receive qualitative services on development of the standard of the organization during as much as possible short time. We shall be glad to work with you!
If necessary experts of our company will specify the list of documents or data necessary for development of the standard of the organization on your production and will in a complex solve all accompanying questions under missing documents.
By inquiry the expert of our company operatively will contact you for discussion of details of the order, terms of carrying out and cost of works.
The Operational Documents
Our company develops key operational documents – «Operation manual», «Passport», «Label» according to requirements of the interstate standard of GOST 2.601 «ESKD. Operational documents». After receipt from you applications experts of the company will lead the analysis of constructive and functional features of your production which input the kind of the operational document will be specified. If necessary our experts are ready to develop divided on parts (in accordance with GOST 2.105) or the incorporated operational document. Construction of your operational document will correspond to requirements of the Technical rules «Requirements to packing, marks, labeling and to their correct drawing», and also to requirements of the interstate standard of GOST 2.105 «ESKD.The general requirements to text documents».
If necessary experts of our company will specify the list of documents or data necessary for development of the operational documentation on your production and will in a complex solve all accompanying questions under missing documents.
By inquiry the expert of our company operatively will contact you for discussion of details of the order, terms of carrying out and cost of works.
Contacts
Albina Ussinova
Manager on registration services and state procurement
CR Dostyk LLP
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