1. Regulatory Amendments Enacted for the State Registration of Medical Devices.

Decree of the Government of the Russian Federation No. 633, dated May 31, 2018, "On Amending the Rules for the State Registration of Medical Devices"

This Decree expands the scope of documentation required for the state registration of medical devices. Applicants must now specify trademark details and other means of individualization in the state registration application, provided such elements appear on the packaging, along with the corresponding OKPD 2 code (Russian Classification of Products by Economic Activity).

The regulatory framework establishes a single-stage registration process for Class 1 potential safety risk medical devices and in vitro diagnostic (IVD) medical devices, completely eliminating the requirement to obtain a clinical trial permit.

The Decree modifies the procedure for amending registration dossiers. Specifically, the regulation distinguishes between amendments that require an expert evaluation of the device's quality, efficiency, and safety, and those that do not. Furthermore, it outlines permissible grounds for amendments and specifies the documentation and data required for such modifications. The competent authority must approve (1) amendments to registration documents requiring quality, efficiency, and safety expert evaluations within a term of 35 business days, and (2) amendments exempt from such evaluations within 15 business days.

Effective date of the document: June 13, 2018.

2. Eurasian Economic Commission Establishes Classification Criteria for Medical Devices.

Recommendation of the Board of the Eurasian Economic Commission No. 25, dated November 12, 2018

This Recommendation clarifies that the intended use of a product governs its classification as a medical device, provided that such intended use remains "exclusive or primary."

The guidelines outline specific criteria to classify products as medical devices across the following product segments:

• Perfumes, cosmetics, and personal hygiene products;

• Disinfection agents and equipment;

• General-purpose products;

• Assistive and rehabilitative devices for individuals with disabilities;

• Sports equipment and physical therapy products;

• Personal protective equipment (PPE);

• Software solutions;

• Packaging and storage equipment designed for medical devices and related products;

• Physiotherapeutic apparatus and consumer-grade appliances;

• Furniture solutions;

• Drug-device combination products;

• In vitro diagnostic products.

Additionally, the guidelines delineate specific intended uses and product examples that fall outside the scope of the medical device classification within these groups.

Effective date of the document: May 16, 2019.

3. Launch of the EAEU Unified Process for the Register of Authorized Medical Device Testing Organizations.

Order of the Board of the Eurasian Economic Commission No. 176, dated November 12, 2018

An EAEU act governing the unified process for the "Compilation, Maintenance, and Application of the Unified Register of Authorized Organizations of the Eurasian Economic Union Conducting Research (Testing) of Medical Devices for Registration Purposes" entered into force on November 26, 2018.

New participants may join this unified process by completing the accession procedure in accordance with the Procedure for Accession to the Unified Process "Compilation, Maintenance, and Application of the Unified Register of Authorized Organizations of the Eurasian Economic Union Conducting Research (Testing) of Medical Devices for Registration Purposes," approved by Decision of the Board of the Eurasian Economic Commission No. 93, dated August 30, 2016.

4. Implementation of the Unified EAEU Medical Device Safety and Quality Monitoring Database.

Order of the Board of the Eurasian Economic Commission No. 177, dated November 12, 2018, "On the Implementation of the Unified Process 'Compilation, Maintenance, and Application of the Unified Information Database for Monitoring the Safety, Quality, and Efficiency of Medical Devices'"

The competent authorities launched the unified process for the "Compilation, Maintenance, and Application of the Unified Information Database for Monitoring the Safety, Quality, and Efficiency of Medical Devices" on November 26, 2018.

New participants shall join the unified process implemented pursuant to this Order by executing the accession procedure prescribed by the Procedure for Accession to the Unified Process "Compilation, Maintenance, and Application of the Unified Information Database for Monitoring the Safety, Quality, and Efficiency of Medical Devices," approved by Decision of the Board of the Eurasian Economic Commission No. 94, dated August 30, 2016.

5. Adoption of the EAEU Classifier for Medical Device Registration Dossier Documents.

Decision of the Board of the Eurasian Economic Commission No. 135, dated August 21, 2018, "On the Classifier of Document Types Issued During the Review of Medical Device Registration Dossiers"

The Board has approved the classifier of document types executed during the evaluation of medical device registration dossiers.

When life sciences market participants compile and submit documents (including electronic formats) to the state authorities of the Eurasian Economic Union member states for registration and related regulatory procedures, they must assign document codes in compliance with this classifier.

The use of the classifier's code designations is mandatory for executing unified processes within the EAEU medical device market landscape.

Effective date of the document: September 23, 2018.

6.  Standardization of Amendments to Medical Device Registration Dossiers Within the EAEU.

Decision of the Board of the Eurasian Economic Commission No. 134, dated August 21, 2018, "On the Directory of Amendment Types Introduced into Medical Device Registration Dossiers"

When introducing amendments under EAEU rules, entities must align with the Directory, which constitutes an integral part of the unified master data and reference information system of the Eurasian Economic Union.

The established regulatory procedure accommodates the following categories of amendments:

• Modifications to the trade name of the medical device;

• Revisions to the composition of accessories, components, and/or consumables;

• Updates to indications for use, scope of application, contraindications, and adverse effects;

• Changes regarding medical device manufacturer data;

• Amendments to information contained within the technical and/or operational documentation of the device;

• Alterations to the applicant's corporate details.

The Directory applies as of September 23, 2018.

7. Distinct Criteria Enacted for the Classification of Medical Device Components for State Registration.

Decision of the Board of the Eurasian Economic Commission No. 116, dated July 24, 2018, "On the Criteria for Differentiating Medical Device Elements Serving as Integral Components for Registration Purposes"

The Decision of the Board of the Eurasian Economic Commission defines and establishes classification criteria for the following regulatory concepts:

• Main block (unit) of a medical device;

• Medical device components;

• Medical device accessories;

• Medical device consumables.

Furthermore, the Annex to the Decision sets forth a standard algorithm for component classification. Applicants must justify any deviations from these algorithmic guidelines within the submitted registration dossier; the regulatory body will verify such justifications during the expert evaluation phase of the medical device registration or dossier amendment procedures.

Effective date of the document: August 25, 2018.

8. EAEU Framework Introduces Rules for Bundling Multiple Product Modifications Under a Single Registration Certificate.

Decision of the Board of the Eurasian Economic Commission No. 123, dated July 24, 2018, "On the Criteria for Including Multiple Modifications of a Medical Device Belonging to a Single Product Type Under One Registration Certificate in Accordance with the EAEU Medical Device Nomenclature"

Pursuant to this Decision, a single registration certificate may encompass multiple product modifications that constitute a size range or execution group, provided they share the following uniform data parameters:

• Product type (pursuant to the EAEU nomenclature classification);

• Manufacturer identity;

• Technical documentation governing the manufacturing process;

• Risk classification;

• The presence and/or quantitative concentration of the identical clinically (or diagnostically) significant analyte(s) within a biological sample (applicable to in vitro diagnostic devices);

Permissible variations among modifications may include the following technical differentiators, provided they do not affect the operational principles or core functional purpose:

• Configuration and packaging variants;

• Secondary technical specifications;

The document remains effective as of August 25, 2018.

9. Adoption of the EAEU Classifier for Adverse Events Linked to Medical Device Utilization.

Decision of the Board of the Eurasian Economic Commission No. 47, dated April 3, 2018, "On the Classifier of Adverse Event Types Associated with the Use of Medical Devices"

This classifier standardizes and systematizes data regarding adverse events linked to medical device utilization. Stakeholders submit this information during post-market surveillance monitoring of the safety, quality, and efficacy of medical devices circulating within the Eurasian Economic Union territory.

The implementation of the classifier's code designations is mandatory when executing unified EAEU regulatory processes within the medical device domain.

Effective date of the document: May 6, 2018.

10. Enactment of the EAEU Classifier for Medical Device Registration Dossier Components.

Decision of the Board of the Eurasian Economic Commission No. 48, dated April 3, 2018, "On the Classifier of Document Types Contained within a Medical Device Registration Dossier"

The Commission has developed a dedicated classifier for document types within a medical device registration dossier (hereinafter the "Classifier"). Utilizing the Classifier's alphanumeric codes is strictly mandatory across all EAEU member states for regulatory compliance in the medical device sector.

The system designates codes for the following document categories:

• Applications;

• Powers of Attorney (PoA);

• Declarations of Conformity;

• Quality Management System (QMS) Certificates of Conformity;

• Regulatory approvals and licenses;

• Evidence of foreign marketing authorizations or third-country registrations;

• Certificates of Free Sale and Export Certificates;

• Technical summaries and device descriptions;

• Packaging layouts and labeling mock-ups;

• Instructions for Use (IFU) and user manuals;

• Clinical or literature reviews;

• Technical evaluation and trial reports;

• Technical specifications and itemized lists;

• Post-market surveillance or trial plans;

• Testing protocols and laboratory logs;

• Official correspondence from medical device manufacturers;

• Miscellaneous data and supplemental documentation.

Effective date of the document: May 6, 2018.

11. Introduction of the Unified Medical Device Nomenclature of the Eurasian Economic Union.

Decision of the Board of the Eurasian Economic Commission No. 46, dated April 3, 2018, "On the Medical Device Nomenclature of the Eurasian Economic Union"

The Commission established the nomenclature system to categorize medical device types uniformly based on their specific classification criteria. Regulatory bodies require this nomenclature for compiling registration dossiers, conducting market surveillance, and facilitating seamless electronic data exchange between member states.

The implementation of these nomenclature codes is legally binding when executing unified cross-border processes within the EAEU life sciences marketplace.

Effective date of the document: May 6, 2018.

12. Ministry of Finance Clarifies VAT Exemption Thresholds for Standalone Sales of Medical Device Accessories.

Letter of the Ministry of Finance of the Russian Federation No. 03-07-14/86270, dated November 29, 2018

The Ministry of Finance of the Russian Federation has issued guidance on the value-added tax (VAT) exemption applicable when market entities sell medical device accessories independently of the primary equipment.

Pursuant to Subparagraph 1 of Paragraph 2 of Article 149 of the Tax Code of the Russian Federation, taxpayers may claim a VAT exemption for transaction volumes involving medical devices (or medical equipment) upon submitting a valid registration certificate to the tax authorities. Eligible certificates include those issued under EAEU law or, until December 31, 2021, those issued under the domestic legislation of the Russian Federation.

The specific inventory of exempt medical products, mapped against the Russian Classification of Products by Economic Activity (OKPD2) and the Unified Commodity Nomenclature of Foreign Economic Activity of the EAEU (TN VED EAEU), is set forth in Decree of the Government of the Russian Federation No. 1042, dated September 30, 2015.

Consequently, the VAT exemption applies to standalone transactions of medical device accessories only if the taxpayer holds specific registration certificates for those independent accessories and the items are explicitly listed within the scope of the automotive registry approved by the aforementioned Government Decree No. 1042.

The Ministry of Finance reaffirmed this legal position in several concurrent guidance letters, including Letter No. 03-07-07/86263 dated November 29, 2018; Letter No. 03-07-07/78832 dated November 2, 2018; Letter No. 03-07-07/64096 dated September 7, 2018; Letter No. 03-07-07/62696 dated September 3, 2018; and Letter No. 03-07-07/21278 dated April 3, 2018.

13. Procurement Rules Mandate Disclosing Registration Certificates for Multi-Manufacturer Medical Device Bids.

Responding to an inquiry regarding whether an electronic auction participant may bid medical devices from two separate manufacturers that both meet the customer's technical criteria, the Ministry provided the following statutory interpretation.

Pursuant to Subparagraph (b) of Paragraph 1 of Part 3 of Article 66 of Federal Law No. 44-FZ "On the Procurement System for the Supply of Goods, Works, and Services for State and Municipal Needs," dated April 5, 2013, the initial portion of an electronic auction bid must detail specific technical metrics conforming to the tender documentation. It must also identify relevant trademarks, service marks, trade names, patents, utility models, industrial designs, and the country of origin.

The auction commission evaluates the first parts of the bids to verify compliance with the procurement criteria. Following this preliminary assessment under Article 66 of Federal Law No. 44-FZ, the commission determines whether to admit or disqualify the candidate from subsequent auction rounds based on technical alignment.

The procurement authority must disqualify an auction participant who fails to supply the requested metrics or provides fraudulent data, or whose bid fails to align with the tender criteria.

Accordingly, the auction commission thoroughly audits the initial part of each bid package to ensure full compliance with the procedural and substantive criteria established for the procured assets.

Russian Federation laws restrict commercial circulation exclusively to medical devices that have successfully obtained registration via the formal tracks established by the Government or its designated federal executive authorities.

Therefore, the Ministry of Finance maintains that if a bidder proposes identical types of medical devices originating from different manufacturers (even if all units meet the underlying tender specifications), the bidder must enclose individual valid registration certificates for each distinct product model within the second portion of the application.

14. Retroactive Application of the 10% Preferential VAT Rate Following OKP-to-OKPD2 Code Migration.

Letter of the Ministry of Finance of the Russian Federation No. 03-07-07/78235, dated October 31, 2018

Government Decree No. 50, dated January 23, 2018, amended the primary regulatory text by substituting legacy OKP codes with the updated OKPD2 code structure. Crucially, Paragraph 3 of Government Decree No. 50 dictates that these coding updates apply retroactively to all applicable legal relationships originating on or after January 1, 2017.

Consequently, starting retroactively from January 1, 2017, corporate entities evaluating eligibility for the preferential 10% VAT rate must interpret the relevant Government Decree exclusively through the lens of the amendments introduced by Decree No. 50.

For unlisted OKPD2 medical product classifications excluded from the preferential schedule, the Ministry of Finance directs corporate counsel to seek formal clarification from the Ministry of Industry and Trade (Minpromtorg).

The Ministry reaffirmed this administrative approach in Letters No. 03-07-07/63701 dated September 6, 2018; No. 03-07-07/63078 dated September 4, 2018; and No. 03-07-07/44705 dated June 28, 2018.

15. Retention of Key Preferential Tax Incentives and VAT Relief for Life Sciences Goods.

Letter of the Ministry of Finance of the Russian Federation No. 03-07-14/45961, dated July 3, 2018

The regulatory framework preserves established fiscal incentives for medical devices, specifically maintaining complete VAT exemptions alongside the preferential 10% reduced tax rate.

Specifically, Paragraph 2 of Article 164 of the Tax Code of the Russian Federation mandates and enforces a reduced 10% VAT rate on pharmaceutical products and medical devices.

Decree of the Government of the Russian Federation No. 688, dated September 15, 2008, sets forth the exhaustive registry of medical items eligible for this reduced tax rate.

16. Conjoint Statutory Criteria Mandated for Local Medical Device VAT Exemptions.

Letter of the Ministry of Finance of the Russian Federation No. 03-07-07/44696, dated June 28, 2018

Under Subparagraph 1 of Paragraph 2 of Article 149 of the Tax Code of the Russian Federation, taxpayers receive a complete VAT exemption on medical items only if they tender a valid registration certificate issued either under EAEU supranational law or, prior to December 31, 2021, under the national statutory rules of the Russian Federation.

Government Decree No. 1042, dated September 30, 2015, codifies the explicit schedule of exempt merchandise, classified under the OKPD2 product matrices and the EAEU TN VED customs code infrastructure.

In light of the foregoing regulatory components, the tax authorities grant the domestic VAT exemption for medical devices strictlyon the dual condition that commercial entities hold valid registration certificates and the devices fall squarely within the scope of the statutory list approved by Government Decree No. 1042.

 

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