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State registration of medical devices in Kazakhstan

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State registration of medical devices in Kazakhstan

According to the Code of the RK on the health of citizens, the main purpose of registration of medical devices is to guarantee their safety for the health of citizens

During the procedure, the quality of the devices and their compliance with current norms and standards are inspected. Only truly high-quality and efficient medical devices successfully pass all checks and are included in the register

Medical devices manufactured in the RK and imported to its territory are subject to registration including the following:

Only those devices are not subject to the state registration that are manufactured under individual orders and do not go on free sale

You will have a lot of work, the nuances of which are unknown to you: 

The procedure may take a long time

You may not know the details of the regulatory environment

You may not know the nuances of communication in regulatory bodies or in the country

We will undertake all the routine work.

You save time and therefore money

We have a team of professionals in different areas of regulatory affairs

We select individual solutions for each project

We guarantee confidentiality

We guarantee that we provide a complete and highly qualified assistance and that we meet the timing and control requirements of the process

List of services

Consulting

Adding changes to the registration certificate

Adding changes to the registration dossier

Preparation and collection of the registration dossier

Development and analysis of technical documentation

Collaboration with testing centers

Interaction with registration bodies

Organization of factor of production assessment

Obtaining official letters from the state body on the pertaining of the product to medical products

Registration stages

According to the current rules in the Republic of Kazakhstan, the registration of medical devices includes the following stages:

  1. Collection of the dossier and receipt of samples

  2. Signing an agreement with the state body

  3. Primary expert examination, which assesses the completeness, contents, and accuracy of the paperwork submitted by the applicant in the registration dossier

  4. Analytical expert examination, including the testing of medical devices samples and determination of the reproducibility of analytical procedures

  5. Inspection of manufacturing of medical devices

  6. Specialized expert examination, which is implemented by studying the documents of the registration dossier for safety, effectiveness, and quality of medical devices

  7. Safety statement, which generates a summary report on the safety, effectiveness, and quality of the medical device

  8. Assigning a registration number and issuing a registration certificate for the medical devices

Service cost

State license fee

5 MCI (monthly calculation index)

The final cost and terms will be calculated at your request

Questions and Answers

1. How is the document calculated?

Documents are calculated in characters. One page equals 1800 characters with spaces.

1. Why do medical devices undergo testing?

To confirm that the product meets the declared technical characteristics, does not pose a danger to human health, and has clinical effectiveness

1. Is it possible to suspend or revoke the registration certificate of a medicine?

Yes, registration is canceled if the registration certificate expires or if this medicine has not been in circulation for more than 3 consecutive years. In addition, its effects may be revoked in the following cases:
• new risks or side effects were found during use;
• information specified in the certificate changed (information about the manufacturer, dosing, and form);
• the manufacturer submitted a request to cancel the registration
1. Kazakhstan Drug Registration Process
2. Kazakhstan List of documents for VIRU-LS

2. What is the period of registration of a medicine?

By law, the registration period is determined as follows:
If you have a complete package of documents, 210 calendar days, not including the preclinical period, the period of clinical trials, the time to eliminate remarks, and inspection of the manufacturing site

3. When is it not possible to conduct clinical or preclinical trials?

When the drug is registered and in circulation for more than 20 years. In all other cases, clinical trials are a mandatory part of the procedure.

1. List of documents required for registration

List of documents required for the provision of public services on application of an Applicant (or his/her representative by power of attorney) according to the technical regulations of the Customs Union:
List of documents-dietary supplement

1. Which documents are required to obtain an import license for medical equipment in Kazakhstan?

1. 199_1
2. 287_1
3. 94_1
4. ZRK About permissions and notifications
5. ZRK About ratification of the Agreement on licensing rules in the field of foreign trade in goods
6. SAM on export control
7. Licenses for the import of certain types of goods
8. License to import products subject to export control
9. Decree No. 104 On approval of the nomenclature (list) of products subject to export control

1. Which documents are required to obtain a license for medical and pharmaceutical activity in Kazakhstan?

1. 232-__1
2. ZRK About permissions and notifications
3. List of required documents (manufacturing of medical devices)
4. List of required documents (wholesale and retail sales of drugs)
5. The list of necessary documents (production of medical devices and MT)
6. List of required documents
7. Order No. 357 On the Approval of the Sanitary Rules. Sanitary and epidemiological requirements for healthcare facilities.

1. List of documents required for registration

1. Kazakhstan List of DS documents

1. Which documents are required for registration?

According to TR CU 009/2011 requirements, for state registration, it is necessary to submit the following:

• an application
• samples of labels and packages
• certified copies of technical documentation (enterprise standard and instruction)
• documents confirming the quality of the product and compliance with the claimed characteristics
• acts and reports of accredited laboratories and research centers
• copies of documents about all essential attributes of a product (organoleptic, physical, microbiological, chemical, etc.)
• annotations with all information about the properties of the specified preparation, instruction for use, and precaution
• manufacturer’s founding documents

If perfumes and cosmetic products contain nanomaterials, you will also need to make copies of documents with complete information about each of them (nanoparticle size, properties, and other characteristics).
If products are imported from abroad, all documents in a foreign language must be translated into Russian. The translations must be certified in the prescribed manner.
1. List of documents for state registration for products manufactured OUTSIDE the territory of the Customs Union
2. Customs Union Technical Regulations 0092011

1. Which documents must be submitted to obtain a certificate of approval of the type of measuring instruments in Kazakhstan?

1. 221-20_1
2. 18195_1
3. Register entry
4. SAM on ensuring the uniformity of measurements
5. Order No. 312 On the Approval of the Rules for Establishing Affiliation of Technical Means to Measuring Instruments
6. Order No. 765 On approval of the List of medical equipment, which is a means of measurement

1. Which documents must be submitted to obtain a certificate of conformity for products in Kazakhstan?

1. List of documents OBK declaration
2. List of OBK documents for serial production
3. List of OBK documents of each series (batch) of products
4. Order No. 269 On the Approval of the Rules for Conducting OBK Drugs and MI from 05/20/2019
5. Cost and terms

1. Which documents on the status of pharmacovigilance activities are required to be submitted?

1) List of the principal data on the medicine of the product license holder
2) Master-file of the pharmacovigilance system (after signing a contract)

2. Are illustrations, images and graphics included in the calculation of a document?

Graphic illustrations are not included in the calculation if there is no text on them that needs translation.