Which Regulatory Documents Govern the National Registration of Medical Devices in the Kyrgyz Republic
List of regulatory legal acts governing the circulation of medical devices:
1. Law of the Kyrgyz Republic of 2 August 2017 No. 166 "On the Circulation of Medical Devices"
2. Decree of the Government of the Kyrgyz Republic No. 311 of 05.07.2018
"On Certain Issues Related to the Registration of Medical Devices" – the Procedure for state registration of medical devices, conducting the examination of safety, quality and effectiveness of medical devices, maintaining the State Register of Medical Devices, maintaining the nomenclature of medical devices, and suspending the validity of a registration certificate.
3. Decree of the Government of the Kyrgyz Republic of 5 July 2018 No. 313
"On Approval of the Procedure for Assessing the Quality and Safety of Medical Devices" – the Procedure for assessing the quality and safety of medical devices
4. Decree of the Government of the Kyrgyz Republic of 1 August 2018 No. 359
"On Approval of the Procedure for Monitoring the Quality, Safety
and Effectiveness of Medical Devices"
5. Decree of the Government of the Kyrgyz Republic of 15 March 2019 No. 120
"On Approval of the Procedure for Inspections in the Sphere of Circulation of Medical Devices"
Stages of state registration of medical devices in the Kyrgyz Republic:
State registration of medical devices consists of the following stages:
- Submission of an application by the applicant
- To obtain state registration of a medical device, the applicant
submits an application to the authorized body in the prescribed form.
- The following are enclosed with the application:
- the registration dossier of the medical device in paper and electronic form
- samples of the medical device are also provided for testing, except for in vitro diagnostic medical devices
2. Initial examination
- After receipt of the application and the registration dossier
- the documents are checked for completeness, and the risk class of the medical device is verified
within 10 working days from the date of submission of the application
3. Request
- If the applicant has submitted an incomplete set of documents
- the authorized body, within 5 working days, requests the missing documents
- If the documents are not submitted within 30 working days from the date the request was received, the authorized body issues a decision to refuse
4. Issuing an invoice for payment
- On the basis of a positive conclusion of the authorized body following the initial examination
- an invoice for payment is issued
- The applicant makes the payment no later than 21 working days
5. Examination of the safety, effectiveness and quality of medical devices
- Following the specialized examination of the medical device, the following is drawn up:
- a conclusion on the assessment of the safety, effectiveness and quality of the medical device.
6. Inspection of production is carried out
- if necessary, for certain medical devices
7. Decision on state registration
- On the basis of the expert conclusion, the authorized body takes a decision
- on state registration
- or on refusal of state registration
within a period not exceeding 3 working days
- Within 10 working days from the date the order on state registration of the medical device is issued, the registration certificate is drawn up in the form approved by the authorized body and is handed to the applicant against signature.
The authorized body notifies the applicant in writing of a decision to refuse state registration of the medical device within 10 working days, stating the reasons
8. Entry of the registered medical device in the state register
Register of medical devices registered in the Kyrgyz Republic
Cost:
The procedure for determining the amount of the fee for state registration is established by the Government of the Kyrgyz Republic. It depends on the risk class of the medical device.
Duration:
State registration of medical devices is carried out:
within a period not exceeding 3 working days
Which devices are registered under national registration only with an inspection?
At present, the legislation on inspections of medical device production is being improved. As soon as the changes enter into force, we will inform the readers of the periodical.
Is it possible to conduct an inspection remotely, by video?
At present there is no practice of conducting inspections remotely by video.
Registration under the EAEU rules
What is the procedure for agreeing the expert conclusion?
1. The applicant must send an application
for agreement of the expert conclusion in the recognition states to the Department of Medicines and Medical Devices
2. The applicant must confirm payment
(send a payment order bearing a mark of execution)
3. The procedure for agreeing the expert conclusion will be initiated
State language
On 31 May 2023, the Jogorku Kenesh (Supreme Council – editor's note) adopted the law on the state language in the Kyrgyz Republic.
The use of the state language is mandatory, among other things:
- in drafting regulatory legal acts
- in record keeping and document flow
- in information on goods and services
How will the innovations affect the procedure for national registration of medical devices in the Kyrgyz Republic and registration under the EAEU rules?
The document is currently undergoing ratification. As soon as the changes enter into force, we will report any additional requirements for translating documentation into the Kyrgyz language.
Official website of the Department of Medicines and Medical Devices under the Ministry of Health of the Kyrgyz Republic: www.pharm.kg
Interview participants:
Aida Ibraimova – Head of Department
Aikerim Sharypova – Deputy Head of Department
Zhanat Karikeev – Head of the Sector
for Assessing Production Conditions of Medical Devices
