Publicly available information in the field of certification of medical products

State Unitary Enterprise "State Center for Expertise and Standardization of Medicines, Medical Devices and Medical Equipment"

Body for certification of medical products

general information

The Certification Body for Medical Devices (SO) was established at the State Center for Expertise and Standardization of Medicines, Medical Devices and Medical Equipment. State Unitary Enterprise "State Center for Expertise and Standardization of Medicines, Medical Devices and Medical Equipment" has the status of a financially, administratively and legally independent legal entity from manufacturers (suppliers) of medical devices and consumers.

State Unitary Enterprise "State Center for Expertise and Standardization of Medicines, Medical Devices and Medical Equipment" adheres to the principles of full economic accounting, self-financing and contractual self-sufficiency. The terms of the contracts concluded with the applicants, which are legally binding agreements of the parties, are in the competence of the authority. Legal and economic independence guarantees complete confidence of consumers and producers in SO as a “third party”, which allows an objective and quick response to consumer requests. By signing an agreement on the provision of certification services, the parties agree to the terms of this agreement and fulfill their obligations under the agreement, including the requirements of UzDST ISO / IEC 17065: 2015, in particular, "certification" must comply with the obligations of clause 4.1.2, which provides for the requirements " Agreement on

The certification body must insure the activities of the certification body to fulfill its obligations arising in the course of its activities.

Certification procedure

Product certification in the Certification Body of Medical Devices (SO) of the State Center for Expertise and Standardization of Medicines, Medical Devices and Medical Equipment includes:

a) Apply for an SO certificate and verify it;

b) analysis of the MoH of the presented product and other documents attached to the application;

c) making a decision on the application;

g) preparation and approval of the test program (except for Figures 6 and 9);

d) identification, selection and delivery of samples to the laboratory (except for Figures 6 and 9);

e) testing of samples in ASL (except for Figures 6 and 9);

k) analysis of the results obtained, issue or refusal to issue a certificate of conformity;

l) registration of the certificate of conformity in the State Register of CMT RUz.

For certification of products in the Certification Body of Medical Devices (SO) of the State Center for Expertise and Standardization of Medicines, Medical Products and Medical Equipment, the applicant submitted an application and an application through the “One-stop shop” system. http://singlewindow.uz/ sends other documents.

When certifying imported products

The following documents must be provided:

sample or product information from the product label;

The following documents are attached to the application for obtaining a certificate of conformity for manufactured products:

a copy of the regulatory document for manufactured products;

sample product labeling (product information);

Certificate of conformity:

for imported goods - the expiration date of the goods;

for serial production - for a period of 3 years.

Application of certification schemes

Figure 1 is used for product type certification and mandatory product specifications include testing in the ASL for safety first. This scheme applies even if the product does not have a specific MH.

Figure 2 is used for product type certification and includes testing the product in accordance with the ASL for mandatory specifications. This scheme involves inspecting the product by testing samples taken from points of sale (consumers).

Figure 3 is used to certify a manufactured product and includes testing the product in accordance with the ASL and evaluating production to verify the mandatory characteristics. The scheme provides for product verification by testing products at the enterprise.

Figure 4 is used in the certification of a manufactured product and includes testing the product in accordance with the ASL and assessing manufacturing conditions to verify mandatory specifications.

This diagram tests samples from a point of sale (consumer) or manufacturing.

It is planned to inspect the goods.

Figure 5 is used in the certification of a manufactured product and includes testing the product in accordance with the ASL and assessing the manufacturing conditions or quality system assessment to verify the mandatory characteristics. The scheme provides for product verification through testing and production inspection (or quality system assessment).

Figure 6 is used for certification of the quality system and provides for its assessment and subsequent control.

Figure 7 is used for product certification and includes product testing.

Figure 7A is used

for certification of a product (except for a vehicle) supplied under a single foreign trade agreement (contract), and provides for testing the product for mandatory characteristics in accordance with ASL.

... Figure 8 is used to certify each product.

Figure 9 relates to product certification and includes the declaration of products in accordance with safety requirements.

3; 4; 5; 7; 7A, 8; Products certified according to 9 drawings can be marked with a conformity mark.

Consideration of appeals

In case of dissatisfaction with the results of certification, interested persons have the right to apply to the Appeals Board of the Uzbek Agency for Technical Regulation or directly to the court.

The Appeals Board of the Uzbek Agency for Technical Regulation will consider appeals against decisions of the certification body and testing laboratories (centers). Appeals will be processed within two weeks in accordance with the procedures outlined in the SMT procedures.

The decision of the Uzbek Agency for Technical Regulation, the Board of Appeals can be appealed in court in the manner prescribed by law.

The certification body for medical devices LLC Scientific Center for Standardization of Medicines will consider complaints and applications within two weeks in accordance with the procedure established by the DP QMS 06: 2020 “Procedural document on the procedure for considering complaints and claims”.

Rights and obligations of the customer

The CO, upon the request of the applicant, must prepare and provide the following information:

a list of types of products subject to mandatory certification or an extract from this list;

Rules for product certification within the framework of CRM accreditation;

price list (tariffs) for certification services;

The accreditation certificate was issued by the State Unitary Enterprise "Accreditation Center".

the customer always complies with the requirements for certification, including the corresponding changes made to it by the certification body.

when continuous manufacturing certification is available, the certified product will always meet the requirements for that product;

provide assessment and inspection control (if necessary), including documentation and records for inspection, as well as access to appropriate equipment, location, space, personnel and subcontractors of the customer;

handling complaints;

if necessary, does everything necessary for the participation of observers.

the customer submits applications for certification in the field of certification;

the customer does not use the certification of the product in a manner that could damage the reputation of the certification body, and does not make any representations regarding the certification of its product that the certification body considers distracting or illegal;

Upon termination, cancellation or termination of certification, the customer ceases to use all advertising materials with reference to the certification and takes the measures required by the certification scheme (for example, the return of certification documents), and any other necessary measures.

Copies of certification documents provided by the customer to other persons must be submitted in full or in accordance with the certification scheme;

when applying for certification of its products in the media, such as documents, brochures or advertising brochures, the customer must comply with the requirements established by the certification body or specified in the certification scheme;

the customer must comply with all the requirements set out in the certification scheme for the use of the conformity mark, as well as the requirements for product information.

does;
the customer keeps a record of all complaints known to him related to compliance with certification requirements, transfers these records to the certification body at his official request:

take appropriate action in relation to any complaints or defects found in the product that affect compliance with such requirements and certification requirements;

document your actions.

the customer must immediately notify the certification body of any changes that may affect the customer's ability to comply with the certification requirements.

Examples of changes:

- change in legal, commercial, organizational status or form of ownership;

- changes in organization and management (for example, changes in senior management, decision-makers, or technical personnel);

- changes in products or production methods;

- changing production data for application and location;

- Significant changes in the quality management system.

Suspend, terminate or revoke certification

The certification body shall decide to take appropriate action in the event of non-compliance with the requirements established during certification, as a result of inspections or in other cases.

approval of certification activities under conditions established by the certification body (for example, enhanced inspection control);

reduction of the volume of the certificate in order to exclude inappropriate

types of products;

suspend certification activities until the customer takes action to eliminate nonconformities;

revoke the certificate.

If certification is terminated (at the request of the customer), the activity is suspended or the certificate of conformity is canceled, the certification body must take appropriate measures and provide all the necessary information about official certification documents, publicly available information, agreement on law. use the conformity mark. you need to make changes.

Ensuring that the certification body takes appropriate action when the scope of the certificate is reduced, and notifies the client of the reduction in the scope of the certificate and clearly and unambiguously identifies the relevant information in certification documents and publicly available information in order to make any necessary changes to the official certification documents , publicly available information, an agreement on the right to use the conformity mark.

If the certificate is terminated, the certification body must notify the purchaser and:

- the necessary measures to confirm the validity of the certificate in accordance with the certification scheme;

- appoint one or more persons to carry out any other activities.

If a certificate is approved after termination, the certification body must use the conformity mark on official certification documents, publicly available information, to ensure that all relevant instructions are available for continuing to certify that product. Make any necessary changes to the agreement on the right. If the decision to reduce the scope of the certificate is a condition of validation, the certification body should clearly indicate the relevant information in the certification documents and publicly available information and indicate the scope to which the certificate belongs. notify the customer about the reduction, make all the necessary changes to the official certification documents, publicly available information, the agreement on the right to use the conformity mark.

Law and regulations

Law of the Republic of Uzbekistan "On certification of products and services."

Law of the Republic of Uzbekistan "On the quality and safety of food products."

Resolution of the Cabinet of Ministers of the Republic of Uzbekistan dated January 30, 2021 "On approval of the list of objects of conformity assessment in the Republic of Uzbekistan".

Resolution of the Cabinet of Ministers of the Republic of Uzbekistan dated July 6, 2004 No. 318 "On additional measures to simplify the procedure for certification of products."

"On approval of the rules for certification of products." (AB registration 18.03.2005 No. 1458)

"On approval of the Rules for checking certified products and services" (Note)

AB 06.04.2005, No. 1464)

"On approval of the Rules for certification of certain types of the same type of products subject to mandatory certification" (Note AB 28.09.2005 No. 1513)

"On approval of the rules for payment for works and services in the National Certification System of the Republic of Uzbekistan." (Note AB dated 11.10.2013 No. 2516).

The General Technical Regulation "On the Safety of Medicines" (UzTR.365-009: 2016) was approved by the Resolution of the Cabinet of Ministers of the Republic of Uzbekistan dated October 27, 2016 No. 365.

Publicly available information in the field of medical product certification

Attachment to the certificate of accreditation

Price list for services provided by the Certification Body of Medical Products

Quality policy

Policy No. C/13-16/50 of professional liability insurance of the certification body

Certificate of accreditation

 

13.06.2022