This service point of Blitz Medica LLP includes several procedures carried out in the field of metrology:
- Inclusion in the Register of the State Measurement System of the Republic of Kazakhstan
- The procedure for recognizing the certificate of measuring instruments of the EAEU countries
- Verification of equipment included in the register of measuring instruments
Metrology: Obtaining a certificate of measuring instruments in Kazakhstan and approval of the type of measuring instruments in the Republic of Kazakhstan
A medical device is a device for diagnosing, preventing or treating diseases. Medical devices may include instruments, devices, consumables, etc. Some medical devices are measuring instruments and require regular verification by government agencies. In addition to State Registration, such medical devices must obtain a certificate of approval of the type of measuring instrument in the Republic of Kazakhstan and the EAEU.
Obtaining a certificate of measuring instruments and inclusion in the Register of the Republic of Kazakhstan and the Eurasian Economic Union: prices, cost and description of services
According to the legislation of the Republic of Kazakhstan «On ensuring the uniformity of measurements»
- Measuring instruments manufactured in series are subject to type approval
- Measuring instruments manufactured by domestic pharmaceutical manufacturers or imported in batches are subject to batch type approval.
The decision on approval of the type of measuring instruments is made by RSE «KazInMetr», based on positive test results and is certified by a certificate of approval of the type of measuring instrument.
Tests for the purpose of approving the type of a batch and for compliance with the approved type of measuring instruments are carried out by the State Scientific Medical Center, including using the material and technical base of accredited testing, verification / calibration laboratories of the Republic of Kazakhstan and the EAEU.
Cost and prices for services for obtaining certificates of measuring instruments in the Republic of Kazakhstan and the EAEU
If you are a manufacturer or distributor of medical devices and need type approval of a measuring instrument or other services in the field of metrology, the Blitz Medica team is ready to help you obtain a conclusion on the approval of measuring instruments.
