APPROVED
order No. 257 dated 10.07.2017	

PRICE SCHEDULE No. 26

for Expertise of Documents on Their Compliance with the Requirements of the Eurasian Economic Union During Registration of Medical Devices

Pos.	Description of services	Unit of measurement	Tariff excluding VAT, US dollars	
1	2	3	4	
1.	Performance of primary expertise of documents	
1.1.	Performance of primary expertise of documents for hazard class 1 medical devices (MD)	one device	82	
1.2.	Performance of primary expertise of documents for hazard class 2a medical devices (MD)	one device	91	
1.3.	Performance of primary expertise of documents for hazard class 2b medical devices (MD)	one device	109	
1.4.	Performance of primary expertise of documents for hazard class 3 medical devices (MD)	one device	101	
2.	General work on expertise of documents during registration of medical devices	
2.1.1.	General work on expertise of documents during registration of hazard class 1 medical devices (MD)	one device	903	
2.1.2.	Analysis of safety and efficacy of a medicinal product as a medical device component, its effect on the medical device’s functionality, the medicinal product’s compatibility with the medical device (except for medical devices for in vitro diagnostics). The medicinal product should be registered and approved for use in its manufacturing country.	one device	236	
2.1.3.	Analysis of medical device sterilisation procedure and methods, materials justifying the sterilisation mode, proposed methods of quality control and determination of residues of sterilising substance during chemical sterilisation	one device	63	
2.1.4.	Studying software validity on the grounds of its verification and validation data analysis, including information on its development, in-house testing and testing during multicentre studies, operation system identification and marking data	one device	16	
2.1.5.	Analysis of information on marketing (if the medical device has been marketed for more than 2 years) (if any)	one device	16	
2.1.6.	Analysis of documents proving the results of medical devices tests with the aim of measuring equipment type approval (with regard to medical devices classified as measuring equipment listed by the Commission)	one device	18	
2.2.1.	General work on expertise of documents during registration of hazard class 2a medical devices (MD)	one device	1 324	
2.2.2.	Analysis of reports on results of medical device manufacture inspection	one device	45	
2.2.3.	Analysis of safety and efficacy of a medicinal product as a medical device component, its effect on the medical device’s functionality, the medicinal product’s compatibility with the medical device (except for medical devices for in vitro diagnostics). The medicinal product should be registered and approved for use in its manufacturing country.	one device	246	
2.2.4.	Analysis of medical device sterilisation procedure and methods, materials justifying the sterilisation mode, proposed methods of quality control and determination of residues of sterilising substance during chemical sterilisation	one device	74	
2.2.5.	Studying software validity on the grounds of its verification and validation data analysis, including information on its development, in-house testing and testing during multicentre studies, operation system identification and marking data	one device	20	
2.2.6.	Analysis of information on marketing (if the medical device has been marketed for more than 2 years) (if any)	one device	18	
2.2.7.	Analysis of documents proving the results of medical devices tests with the aim of measuring equipment type approval (with regard to medical devices classified as measuring equipment listed by the Commission)	one device	18	
2.3.1.	General work on expertise of documents during registration of hazard class 2b medical devices (MD)	one device	1 547	
2.3.2.	Analysis of reports on results of medical device manufacture inspection	one device	55	
2.3.3.	Analysis of safety and efficacy of a medicinal product as a medical device component, its effect on the medical device’s functionality, the medicinal product’s compatibility with the medical device (except for medical devices for in vitro diagnostics). The medicinal product should be registered and approved for use in its manufacturing country.	one device	246	
2.3.4.	Analysis of medical device sterilisation procedure and methods, materials justifying the sterilisation mode, proposed methods of quality control and determination of residues of sterilising substance during chemical sterilisation	one device	74	
2.3.5.	Studying software validity on the grounds of its verification and validation data analysis, including information on its development, in-house testing and testing during multicentre studies, operation system identification and marking data	one device	19	
2.3.6.	Analysis of information on marketing (if the medical device has been marketed for more than 2 years) (if any)	one device	31	
2.3.7.	Analysis of documents proving the results of medical devices tests with the aim of measuring equipment type approval (with regard to medical devices classified as measuring equipment listed by the Commission)	one device	18	
2.4.1.	General work on expertise of documents during registration of hazard class 3 medical devices (MD)	one device	1 523	
2.4.2.	Analysis of reports on results of medical device manufacture inspection	one device	62	
2.4.3.	Analysis of safety and efficacy of a medicinal product as a medical device component, its effect on the medical device’s functionality, the medicinal product’s compatibility with the medical device (except for medical devices for in vitro diagnostics). The medicinal product should be registered and approved for use in its manufacturing country.	one device	246	
2.4.4.	Analysis of medical device sterilisation procedure and methods, materials justifying the sterilisation mode, proposed methods of quality control and determination of residues of sterilising substance during chemical sterilisation	one device	63	
2.4.5.	Studying software validity on the grounds of its verification and validation data analysis, including information on its development, in-house testing and testing during multicentre studies, operation system identification and marking data	one device	19	
2.4.6.	Analysis of information on marketing (if the medical device has been marketed for more than 2 years) (if any)	one device	31	
2.4.7.	Analysis of documents proving the results of medical devices tests with the aim of measuring equipment type approval (with regard to medical devices classified as measuring equipment listed by the Commission)	one device	18	
3.	Settlement of disputes during expertise of documents on medical devices (if any)	
3.1.	Settlement of disputes during expertise of documents on medical devices (if any) in case of external participation of experts of the Centre for Examinations and Tests in Health Service Unitary Enterprise in the meeting	one device	226	
3.2.	Settlement of disputes during expertise of documents on medical devices (if any) in case of internal participation of experts of the Centre for Examinations and Tests in Health Service Unitary Enterprise in the meeting (excluding costs for assignment of the experts)	one device	513	
4.	Medical devices registration	one device	48	
5.	Expertise of changes introduced into the registration dossier of the MD	
5.1.	Expertise of changes introduced into the registration dossier of hazard class 1 MD	one device	316	
5.2.	Expertise of changes introduced into the registration dossier of hazard class 2a MD	one device	359	
5.3.	Expertise of changes introduced into the registration dossier of hazard class 2b MD	one device	398	
5.4.	Expertise of changes introduced into the registration dossier of hazard class 3 MD	one device	425	
6.	Issuance of duplicate marketing registration certificate	one certificate	25	
7.	MD expert report approval	
7.1.	Hazard class 1 MD expert report approval	one device	866	
7.2.	Hazard class 2a MD expert report approval	one device	1 491	
7.3.	Hazard class 2b MD expert report approval	one device	1 665	
7.4.	Hazard class 3 MD expert report approval	one device	1 674	
8.	MD expert report approval for introduction of changes into the registration dossier	
8.1.	Hazard class 1 MD expert report approval for introduction of changes into the registration dossier	one device	100	
8.2.	Hazard class 2a MD expert report approval for introduction of changes into the registration dossier	one device	117	
8.3.	Hazard class 2b MD expert report approval for introduction of changes into the registration dossier	one device	135	
8.4.	Hazard class 3 MD expert report approval for introduction of changes into the registration dossier	one device	145	

Notes:
1.	Tariffs of this price schedule are effective in the territory of the Republic of Belarus and include the services rendered by the Centre for Examinations and Tests in Health Service Republican Unitary Enterprise associated with expertise of documents for their compliance with the requirements of the Eurasian Economic Union during registration of medical devices for non-residents of the Republic of Belarus.

2.	The price of technical tests, laboratory studies (tests), clinical (medical) tests, materials, travel expenses associated with transportation to the place of assignment and back, accommodation, payment of daily expenses to the assigned experts, additional works and services required for rendering services (performance of works) stated in this price schedule as per their description, shall be additionally paid by the applicant in accordance with the legislation of the Republic of Belarus.

3.	Settlements with non-residents for performance of a complex of preliminary technical works associated with expertise, inspection evaluation, tests and other studies preceding state registration (reregistration) of medical products and devices shall be performed in accordance with valid legislation of the Republic of Belarus on foreign exchange regulation.

4.	The state fee into the Republican budget for registration, reregistration of medical devices shall be charged additionally pursuant to and in accordance with valid legislation of the Republic of Belarus.

5.	For the second and each subsequent article of a medical device produced by the same manufacturer under the same normative and technical documentation during expertise of documents for their compliance with the requirements of the Eurasian Economic Union during registration of medical devices an additional fee in the amount of 20% of the tariff specified by this price schedule shall be charged.
6.	The tariffs of this price schedule may be discounted as per the instruction of the Ministry of Health of the Republic of Belarus as regards certain articles of medical devices presented for expertise of documents for their compliance with the requirements of the Eurasian Economic Union during registration.