Kyrgyzstan medical device regulations

Complete official amendment resolution. Its device-specific provisions amend the quality and safety assessment procedure adopted by Resolution 626/2024; its medicines provisions are retained as part of the original legal instrument. The separately maintained consolidated device assessment procedure incorporates this amendment.

Complete official Russian text of Law 252 of 3 November 2025, amending both the medicines and medical-device circulation laws. Preserves the amending provisions and commencement clause as a distinct legal expression, alongside the consolidated medical-device law.

Device-registration application: product, intended use/field, risk/GMDN, drug component, configuration, storage, foreign registrations, manufacture and authorized representative; guarantee/signature. The GMDN field is conditional (if available); no universal GMDN submission obligation is inferred. The source header refers to order 299 dated 30 September 2024; the signed parent order and current amendment chain remain unverified. No publication or effective date is inferred from that reference or Office metadata.

Device-registration application: product, intended use/field, risk/GMDN, drug component, configuration, storage, foreign registrations, manufacture and authorized representative; guarantee/signature. The GMDN field is conditional (if available); no universal GMDN submission obligation is inferred. The source header refers to order 299 dated 30 September 2024; the signed parent order and current amendment chain remain unverified. No publication or effective date is inferred from that reference or Office metadata. This Russian header attributes the order to the Ministry of Health, while other annex headers name DLSMI; the issuer discrepancy is unresolved.

Device registration dossier change application with six before/after change categories and declaration that changes do not alter properties affecting safety, quality or effectiveness; lifecycle guarantee. The source header refers to order 299 dated 30 September 2024; the signed parent order and current amendment chain remain unverified. No publication or effective date is inferred from that reference or Office metadata.

Device registration dossier change application with six before/after change categories and declaration that changes do not alter properties affecting safety, quality or effectiveness; lifecycle guarantee. The source header refers to order 299 dated 30 September 2024; the signed parent order and current amendment chain remain unverified. No publication or effective date is inferred from that reference or Office metadata.

Request to cancel/annul medical-device registration certificate, identifying applicant/device/accessories/certificate and reason. The source header refers to order 299 dated 30 September 2024; the signed parent order and current amendment chain remain unverified. No publication or effective date is inferred from that reference or Office metadata.

Request to cancel/annul medical-device registration certificate, identifying applicant/device/accessories/certificate and reason. The source header refers to order 299 dated 30 September 2024; the signed parent order and current amendment chain remain unverified. No publication or effective date is inferred from that reference or Office metadata.

Medical-device registration certificate template with indefinite validity, original-registration and change dates; integral component/accessory/consumable attachment present on rendered page2. The source header refers to order 299 dated 30 September 2024; the signed parent order and current amendment chain remain unverified. No publication or effective date is inferred from that reference or Office metadata.

Medical-device registration certificate template with indefinite validity, original-registration and change dates; integral component/accessory/consumable attachment present on rendered page2. The source header refers to order 299 dated 30 September 2024; the signed parent order and current amendment chain remain unverified. No publication or effective date is inferred from that reference or Office metadata.

Incident notification from any medical-device circulation entity/users/healthcare organizations;12 fields and supporting-copy attachment. The form names device circulation entities, users and healthcare organizations; its existence alone does not establish every reporting deadline or trigger. The source header refers to order 299 dated 30 September 2024; the signed parent order and current amendment chain remain unverified. No publication or effective date is inferred from that reference or Office metadata.

Incident notification from any medical-device circulation entity/users/healthcare organizations;12 fields and supporting-copy attachment. The form names device circulation entities, users and healthcare organizations; its existence alone does not establish every reporting deadline or trigger. The source header refers to order 299 dated 30 September 2024; the signed parent order and current amendment chain remain unverified. No publication or effective date is inferred from that reference or Office metadata.

Safety notice: suspension,replacement,return,on-site modification,destruction,IFU/operating-instruction change,software update;user communication/forwarding and authority-informed confirmation. The source header refers to order 299 dated 30 September 2024; the signed parent order and current amendment chain remain unverified. No publication or effective date is inferred from that reference or Office metadata.

Safety notice: suspension,replacement,return,on-site modification,destruction,IFU/operating-instruction change,software update;user communication/forwarding and authority-informed confirmation. The source header refers to order 299 dated 30 September 2024; the signed parent order and current amendment chain remain unverified. No publication or effective date is inferred from that reference or Office metadata.

Manufacturer/authorized representative incident report;initial/follow-up/final;device/GMDN/UDI/risk,incident,patient,healthcare organization,initial analysis and final investigation;mandatory-field legends1/2/3. Field legends distinguish initial, follow-up and final reports; conditional GMDN/UDI/risk fields are not universal requirements for every device. The source header refers to order 299 dated 30 September 2024; the signed parent order and current amendment chain remain unverified. No publication or effective date is inferred from that reference or Office metadata.

Manufacturer/authorized representative incident report;initial/follow-up/final;device/GMDN/UDI/risk,incident,patient,healthcare organization,initial analysis and final investigation;mandatory-field legends1/2/3. Field legends distinguish initial, follow-up and final reports; conditional GMDN/UDI/risk fields are not universal requirements for every device. The source header refers to order 299 dated 30 September 2024; the signed parent order and current amendment chain remain unverified. No publication or effective date is inferred from that reference or Office metadata.

Manufacturer/authorized representative corrective safety action report;initial/follow-up/final;device/GMDN/UDI/risk,FSCA reasons/actions/schedule,attachment of safety notice in Russian;mandatory-field legends1/2/3. Field legends distinguish report stages; conditional GMDN/UDI/risk fields are not universal requirements for every device. The source header refers to order 299 dated 30 September 2024; the signed parent order and current amendment chain remain unverified. No publication or effective date is inferred from that reference or Office metadata.

Manufacturer/authorized representative corrective safety action report;initial/follow-up/final;device/GMDN/UDI/risk,FSCA reasons/actions/schedule,attachment of safety notice in Russian;mandatory-field legends1/2/3. Field legends distinguish report stages; conditional GMDN/UDI/risk fields are not universal requirements for every device. The source header refers to order 299 dated 30 September 2024; the signed parent order and current amendment chain remain unverified. No publication or effective date is inferred from that reference or Office metadata.

Postregistration clinical monitoring report;17 sections;class3 nonimplantable/implantable and implanted class2b choices;residual risks,clinical data,plan adjustment,FSCA,cycle extension. Class 3 nonimplantable/implantable and implanted class 2b choices are preserved; this form is not evidence of a blanket monitoring obligation for all devices or IVDs. The source header refers to order 299 dated 30 September 2024; the signed parent order and current amendment chain remain unverified. No publication or effective date is inferred from that reference or Office metadata.

Postregistration clinical monitoring report;17 sections;class3 nonimplantable/implantable and implanted class2b choices;residual risks,clinical data,plan adjustment,FSCA,cycle extension. Class 3 nonimplantable/implantable and implanted class 2b choices are preserved; this form is not evidence of a blanket monitoring obligation for all devices or IVDs. The source header refers to order 299 dated 30 September 2024; the signed parent order and current amendment chain remain unverified. No publication or effective date is inferred from that reference or Office metadata.

Applicant declaration of responsibility for reliability of information/data submitted for a specified device procedure; list of documents/pages and applicant/company/passport/contact fields. The source header refers to order 299 dated 30 September 2024; the signed parent order and current amendment chain remain unverified. No publication or effective date is inferred from that reference or Office metadata.

Applicant declaration of responsibility for reliability of information/data submitted for a specified device procedure; list of documents/pages and applicant/company/passport/contact fields. The source header refers to order 299 dated 30 September 2024; the signed parent order and current amendment chain remain unverified. No publication or effective date is inferred from that reference or Office metadata.

Russian adoption and four annexes for issuing device quality/safety conclusions, copies and duplicates, including shared medicine/device context and printed work-time norms. Selected physical pages1–2 and5–47. Currentness unverified; this is not a device registration-variation deadline or a fee schedule.

Complete approving resolution from the Ministry of Justice legal database. Establishes national registration and vigilance procedures and incorporates specified EAEU classification, safety, labelling and testing instruments. Registration and vigilance annexes are separately published expressions and require separate acquisition. Its repeal clause identifies the older 311/2018 and 359/2018 rules.

Ministry of Health Order 501 of 28 June 2016 introduces an Internet system for recording medical equipment in healthcare organisations. It approves a user guide and assigns data-entry, reporting, integration and monitoring responsibilities with rollout tasks dated 2016. Point 5 expressly repeals Orders 489 of 24 September 2008 and 478 of 5 October 2011. The supplied two-page PDF contains the complete main order; the separately linked user guide has not been reviewed here. Subsequent legal status remains unverified.