D. Grinko. Recent Developments in Medical Device Registration in the Republic of Belarus

An overview of the state registration procedure, the preliminary technical works that precede it, and the standard, simplified and limited-quantity registration tracks.

Legal basis for placing medical devices into circulation

Medical devices may be manufactured, sold and used (operated) for medical purposes in the Republic of Belarus only:

• after their state registration, in the manner established by the Council of Ministers of the Republic of Belarus, or
• after registration within the framework of the Eurasian Economic Union, unless otherwise provided by this Law, other legislative acts, or international legal acts forming the law of the Eurasian Economic Union.

The administrative procedure for state registration is governed by:

• the Regulation on the State Registration (Re-registration) of Medical Devices and Medical Equipment (hereinafter — the Regulation), approved by Resolution of the Council of Ministers of the Republic of Belarus No. 1269 of 2 September 2008 (as amended), administered in the Republic of Belarus by the Ministry of Health;
• the Unified List of Administrative Procedures Performed in Respect of Business Entities, approved by Resolution of the Council of Ministers of the Republic of Belarus No. 548 of 24 September 2021.

Under this Regulation, devices intended by the manufacturer for use in medicine for:

• prevention,
• diagnosis,
• treatment,
• rehabilitation, or
• prosthetic care of the population

are subject to state registration with the Ministry of Health of the Republic of Belarus and entry into the State Register of Medical Devices and Medical Equipment of the Republic of Belarus, published at www.rceth.by.

Under paragraph 3, chapter 1 of the Regulation, state registration (re-registration) of medical devices and medical equipment, and any amendment of the registration dossier for medical devices and medical equipment previously registered in the Republic of Belarus, approved by Resolution of the Council of Ministers of the Republic of Belarus No. 1269 of 2 September 2008, is preceded by a set of preliminary technical works (hereinafter — KPTR).

Under these instruments, the state registration procedure, including issuance of the registration certificate, is carried out by:

• the Ministry of Health of the Republic of Belarus.

The set of preliminary technical works that precedes it:

• is carried out by the Republican Unitary Enterprise "Center for Expertise and Testing in Healthcare" (hereinafter — CETH), an organization subordinate to the Ministry of Health of the Republic of Belarus.

What CETH does

Today, drawing on more than 25 years of history, CETH's areas of competence include the following functions.

The set of preliminary technical works preceding state registration (re-registration) of:

• medical devices and medical equipment,
• medicinal products,
• biomedical cell products,
• quality control and development (validation/verification) of quality control methods for medicinal products,
• inspection of the manufacture of medical devices and medical equipment.

Processing documents and preparing decisions for:

• a significant number of administrative procedures for which the authorized body is the Ministry of Health of the Republic of Belarus, including those relating to the issuance of a conclusion (permitting document) for the import — across the state border of the Republic of Belarus, subject to movement restrictions — of registered and unregistered medicinal products and/or pharmaceutical substances, on grounds established by the legislation of the Republic of Belarus;
• the issuance of a conclusion (permitting document) approving licenses to import narcotic drugs, psychotropic substances and their precursors into the Republic of Belarus.

Receiving and verifying documents for the registration of manufacturers' maximum selling prices for medicinal products, and maintaining and updating the state register of manufacturers' maximum selling prices for medicinal products in the Republic of Belarus.

Quality control of medicinal products and pharmaceutical substances.

Technical testing and sterility control of certain types of medical devices.

Issuing a conclusion confirming the intended use of imported goods (for the purpose of determining the customs duty rate) —

• for medical devices, prosthetic and orthopedic devices and medical equipment, or raw materials and components used to manufacture them, or semi-finished products for them.

Issuing a conclusion on the possibility of carrying out works (rendering services) for the maintenance and repair of medical equipment (for legal entities and individual entrepreneurs that are not manufacturers of medical equipment).

Carrying out activities within the framework of pharmacovigilance and medicinal product quality control.

Approving advertising of a medicinal product, of a method of medical care, or of work or a service that constitutes:

• medical activity,
• a medical device,
• medical equipment,
• a biologically active food supplement.

Participants in state registration and KPTR

A legal entity (individual entrepreneur) of the Republic of Belarus

• that manufactures medicinal products and has placed an order for the manufacture and/or purchase of foreign-made medical devices intended for use in the industrial manufacture of medicinal products, where such medical devices have not been registered in the Republic of Belarus by the foreign manufacturer;

A legal entity (individual entrepreneur) involved in the circulation of medical devices and medical equipment supplied in a limited quantity

• for state healthcare organizations, for the purpose of implementing international healthcare programs;
• for medical use in an emergency situation, or for diagnosing new, naturally occurring focal, or especially dangerous infectious diseases, supplied as foreign gratuitous aid (hereinafter, unless otherwise specified — medical devices and medical equipment supplied in a limited quantity).

Carrying out KPTR for medical devices: types and timeframes

CETH carries out KPTR in the cases and manner determined by the Ministry of Health, comprising the following work:

• primary examination of documents,
• inspection of the manufacture of medical devices and medical equipment,
• sanitary-hygienic (biological) testing of domestically and foreign-made medical devices and medical equipment,
• technical testing of domestically manufactured medical devices and medical equipment,
• specialized examination of documents,
• clinical trials of medical devices and medical equipment ordered by the Ministry of Health,
• clinical evaluation based on clinical data, and proof of equivalence to medical equipment previously registered in the Republic of Belarus (for large-scale equipment requiring utility connections and/or construction and installation works),
• other studies (where required).

The procedure for conducting KPTR is set out in the Instruction "On the Set of Preliminary Technical Works Preceding the State Registration of Medical Devices," approved by Resolution of the Ministry of Health of the Republic of Belarus No. 55 of 23 April 2015 (as amended).

• To carry out KPTR, the applicant submits to CETH the documents listed in Annex No. 1 to the Instruction.
• The primary examination of documents is carried out on the basis of an agreement concluded between the Enterprise and the applicant.

The process runs as follows:

• concluding an agreement for the primary examination of documents,
• submitting the registration dossier together with an application for primary examination,
• examination of the documents (legal and technical),
• issuing the applicant a conclusion on the results of the primary examination, identifying the type of work to be carried out during KPTR,
• concluding an agreement for KPTR, and issuing a conclusion on the results of KPTR with a recommendation for state registration.

The primary examination of documents covers:

• checking the completeness of the document set and the correctness of how it is drawn up,
• checking the completeness and currency of the information provided,
• clarifying the list and names of the medical devices and medical equipment in line with the nomenclature classification of medical devices and medical equipment by type and by class, according to the potential risk of their use.

At present, a foreign manufacturer in the Republic of Belarus has a choice of several types of KPTR preceding state registration of medical devices, and may select among them based on economic feasibility and on the documents it holds that have been issued by regulatory bodies in the field of medical device circulation.

Standard KPTR procedure

The work preceding state registration (re-registration) of foreign-made medical devices and medical equipment consists of:

• primary examination of documents,
• concluding the KPTR agreement,
• inspection of the manufacture of medical devices and medical equipment (in the cases provided for by law),
• sanitary-hygienic (biological) testing of domestically and foreign-made medical devices and medical equipment,
• specialized examination of documents, including:
  • clinical trials of medical devices and medical equipment ordered by the Ministry of Health (assigned based on the results of the specialized examination — where clinical efficacy of the medical device has not been proven, or the evidence is insufficient),
  • clinical evaluation based on clinical data, and proof of equivalence to medical equipment previously registered in the Republic of Belarus (for large-scale equipment requiring utility connections and/or construction and installation works).

"Simplified" KPTR procedures

These are implemented in two variants.

Variant 1

Work preceding state registration (re-registration) of foreign-made medical devices and medical equipment already in circulation in the territory of the United States of America or of a European Union member state (the "simplified procedure"):

• primary examination of documents,
• concluding the KPTR agreement,
• specialized examination of documents with a finding on whether the medical device can be registered.

In addition to the other documents listed in the Instruction, the manufacturer must submit to CETH:

• a document confirming that the medical device or medical equipment complies with the requirements of Regulation (EU) 2017/746 or Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017,
• or a document authorizing the circulation of the medical device or medical equipment in the United States of America (including a certificate for free sale, a declaration of conformity, or a certificate of conformity),
• or information published on the official website of the relevant regulatory authority confirming the above.

Variant 2

Work preceding state registration of medical devices and medical equipment supplied to the Republic of Belarus in a limited quantity for:

• state healthcare organizations, for the purpose of implementing international healthcare programs;
• the emergency needs of state healthcare organizations, including for eliminating the consequences of natural disasters, catastrophes and epidemic diseases;
• other exceptional cases, as well as for treating limited groups of patients, including patients with rare conditions, where the devices are supplied as foreign gratuitous aid.

Based on the results of KPTR, a conclusion is issued on whether the limited quantity intended for use at a specific healthcare institution may be registered.

Documents are accepted as copies certified by the applicant. In addition to all other required documents, the applicant must also submit documents:

• confirming the need to sell and/or use the medical devices and medical equipment for medical purposes, drawn up on the letterhead of the healthcare organization with all required details, and substantiating the need to apply the medical devices and medical equipment for medical use in an emergency situation or for the diagnosis of new, naturally occurring focal, or especially dangerous infectious diseases.

State registration and issuance of the registration certificate

This includes the following stages:

• review by the Commission on Medical Devices and Medical Equipment of the conclusion on the quality and safety of the product,
• issuance of an order by the Ministry of Health of the Republic of Belarus,
• issuance by CETH of an invoice and a letter requesting payment of the state duty,
• issuance by CETH of the Registration Certificate,
• entry into the State Register of Medical Devices and Medical Equipment.

Registration results in the issuance of an indefinite (perpetual) registration certificate.

A registration certificate for a limited quantity of medical devices is issued for a specific series (batch) of product intended for supply within the Republic of Belarus and for use at a specific healthcare organization.

Inspection of medical device manufacturing

Manufacturing inspection is carried out as part of KPTR, under a separate agreement between CETH and the applicant covering the inspection itself.

Manufacturing inspection is carried out when:

• the applicant submits medical devices and medical equipment manufactured at a production site declared for the first time — ! except for foreign-made medical devices and medical equipment of potential risk class I (other than sterile medical devices and medical equipment);
• the applicant submits medical devices and medical equipment manufactured at a production site previously declared only in connection with the state registration of foreign-made medical devices and medical equipment already in circulation in the territory of the United States of America or of European Union member states, or of medical devices and medical equipment manufactured and approved for use in EAEU member states and already in circulation in the territory of the United States of America or of European Union member states, or of medical devices and medical equipment supplied in a limited quantity — ! except for foreign-made medical devices and medical equipment of potential risk class I (other than sterile medical devices and medical equipment);
• the applicant submits medical devices and medical equipment of potential risk class I (sterile), IIa, IIb or III manufactured at a production site previously declared only in connection with the state registration of medical devices and medical equipment of potential risk class I (other than sterile medical devices and medical equipment);
• the manufacturer's production site address changes;
• a production site address is added for the manufacturer for the first time.

Accordingly, manufacturing inspection is not carried out for any of the "simplified procedures" of state registration.

The inspection covers:

1. verification of how incoming inspection of raw materials and supplies is organized;
2. identification and traceability of medical devices and medical equipment;
3. verification of how the manufacturing processes for medical devices and medical equipment are managed;
4. verification of how control, measuring and testing equipment is managed;
5. a study of the manufacturing processes for medical devices and medical equipment, including verification that documentation on the organization of the manufacturing process exists;
6. a study of the control and testing methods used at every stage of manufacturing medical devices and medical equipment;
7. verification of storage conditions, packaging types and labeling of medical devices and medical equipment;
8. a study and assessment of the safety, quality and efficacy of the medical devices and medical equipment, and of their compliance with international standards and with the regulatory legal acts of the Republic of Belarus.

To conduct the inspection, the Enterprise:

• determines the timing and conditions for the inspection,
• forms an inspection commission made up of experts who are employees of the Enterprise.

The inspection is carried out under a separate agreement between CETH and the applicant, concluded within the term of the KPTR agreement.

During the inspection, the inspection commission may decide to recognize the sanitary-hygienic test protocols submitted by the manufacturer as protocols and/or reports of sanitary-hygienic testing of medical devices and medical equipment issued by accredited laboratories (centers), provided the medical devices and medical equipment comply with the sanitary norms and rules governing safety requirements for medical devices and medical equipment.

* Complexity group 1 — potential risk classes 3, 2b, 2a, and in-vitro diagnostic medical devices; complexity group 2 — potential risk class 1 (sterile); complexity group 3 — potential risk class 1 (non-sterile). The state duty amount as of 31.03.2024 is 37 Belarusian rubles.

All regulatory documents on the circulation of medical devices, together with the current KPTR price lists, are published on the CETH website, www.rceth.by.

References

1. Law of the Republic of Belarus "On Healthcare" No. 2435-XII of 18 June 1993 (as amended by Law No. 308-З of 25 October 2023).
2. Resolution of the Council of Ministers of the Republic of Belarus "On Approval of the Regulation on the State Registration (Re-registration) of Medical Devices and Medical Equipment" No. 1269 of 2 September 2008.
3. Resolution of the Ministry of Health of the Republic of Belarus "On the Set of Preliminary Technical Works Preceding the State Registration of Medical Devices" No. 55 of 23 April 2015.

Author

Other articles · Issue No. 1, 2024, Electronic Periodical Publication PRO MEDIZDELIYA