Registration of medical devices is the first step in the process of bringing them to the pharmaceutical market. This procedure is an examination of the quality, efficacy and safety of a medical device, which is carried out for the subsequent issuance of a permit for its medical use.

Re-registration of medical devices is an extension of the registration validity period for a certain period, accompanied by the issuance of a new registration certificate under the previous registration number.

Making changes to the registration dossier of medical devices - this procedure involves changing the data of a previously registered medical device. Changes made should not reduce the safety and quality of the product.

Registration of medicinal products is the first step in the process of its introduction to the pharmaceutical market. This procedure is an examination of the quality, efficacy and safety of the drug, which is carried out for the subsequent issuance of permission for its medical use.

Re-registration of a medicinal product is an extension of the registration validity period for a certain period, accompanied by the issuance of a new registration certificate under the previous registration number.

Making changes to the registration dossier of medicinal products This procedure involves changing the data of a previously registered medicinal product. Changes made should not reduce the safety and quality of the product.

Medical translation is a translation from one language into another of specialized medical publications and texts of a private nature, the content of which is directly related to human health. The special position of this category of specialized translations is determined by the importance of any information being translated, the increased requirements for the accuracy of the translation and respect for the confidentiality of private information, as well as the pronounced heterogeneity of the terminology used.

Analytical regulatory document (hereinafter referred to as the RD) is a document that establishes a set of quality standards for a medicinal product of the manufacturing enterprise, methods for their determination, ensuring the same safety and efficacy of the medicinal product, regardless of the series, as well as the constancy and uniformity of its production.

Instructions for use of a medicinal product - an official document containing information about a medicinal product, medical device necessary and sufficient for its effective and safe medical use.

Coordination and (or) permits for import into the territory of the Republic of Kazakhstan must be obtained by unregistered medical devices when importing samples for examination, state registration, re-registration and amendments to the registration dossier; for holding exhibitions of medical devices without the right to further sale; for use as a component that is part of or device of a medical device and is not intended for independent use outside the composition or device of a medical device; for clinical research.

Confirmation of the safety of dietary supplements, baby food is the presence of a certificate of state registration issued in the manner approved by the authorized body in the field of sanitary and epidemiological welfare of the population.

Perfume and cosmetic products are put into circulation on the market in full compliance with this Technical Regulation, as well as other documents of the Eurasian Economic Union, the requirements of which apply to it. But if the product does not meet the requirements of these documents, marking it with a single mark of product circulation on the market of the member states of the Eurasian Economic Union, then placement and sale on the market is not allowed.

State registration of disinfectants is a mandatory stage that all products must pass before entering the market. According to the procedure for registering disinfectants established in the Customs Union, products of the following groups must pass the procedure: insect repellents from arthropods, rodents.

Approval of the type of measuring instrument - a decision made by the body of the state metrological service, indicating the compliance of the measuring instrument with the established requirements and the suitability of its use in the areas of distribution of state metrological control and supervision.

Pharmacovigilance is a type of activity aimed at identifying, analyzing, evaluating and preventing undesirable consequences of the use of drugs.

A declaration of conformity is a document in which the manufacturer (importer, seller) certifies that the products comply with the norms and rules in force at the time of registration (GOSTs, Technical regulations, etc.)

Examination of product belonging to medical devices and the need for its state registration in the Republic of Kazakhstan

The quality assessment of medicines and medical devices is carried out in order to establish the conformity of the quality of specific batches (batches) of medicines imported into the country or manufactured in the country with the requirements of a regulatory document on quality.

Reference pricing for drugs - a system for analyzing prices for the trade name of a drug, based on the prices submitted by the applicant for the same manufacturer of drugs with the same active substance, taking into account the dosage form, concentration and dosage in the reference countries, as well as the actual prices of deliveries to the Republic of Kazakhstan

Лицензирование экспорта и импорта продукции проводится с целью официального признания уполномоченным органом в сфере экспортного контроля правомочий физического или юридического лица осуществлять экспорт или импорт продукции, подлежащей экспортному контролю.

Licensing of medical and pharmaceutical activities is carried out by the authorized body in the field of healthcare and local executive bodies of regions, cities of republican significance and the capital.

Advertising permit - a document issued by the Department confirming the right to distribute and place advertising

The certificate of a specialist (hereinafter referred to as the certificate) indicates that its holder has achieved a level of theoretical knowledge, practical skills and abilities sufficient for independent professional (medical or pharmaceutical) activities.

The certificate of a specialist (hereinafter referred to as the certificate) indicates that its holder has achieved a level of theoretical knowledge, practical skills and abilities sufficient for independent professional (medical or pharmaceutical) activities.