In the Republic of Uzbekistan, a robust mechanism is in place to monitor the health status of the population, ensure the provision of quality medical care, and enforce international standards in the production of medical equipment. This sector is governed by a series of resolutions and pertinent documents issued at both governmental and ministerial levels.

The Government has actively adopted international standards to safeguard public health, including those defined by the International Organization for Standardization (ISO). Notably, standards such as ISO 15189 and ISO 13485 have been introduced in recent years to enhance the quality of medical services and products.

 

 

The quality infrastructure in Uzbekistan is increasingly focused on integrating these standards and evaluating compliance during accreditation processes. The National Accreditation System prioritises the expansion of the service sector, recognising its vital role in ongoing development and public welfare. While the achievement of international recognition is commendable, the ongoing maintenance and improvement of standards remain critical.

 

 

The State Enterprise Uzbek Center for Accreditation (O’ZAKK) successfully achieved international recognition in several scope, including in Medical Device Quality Management Systems as per ISO 13485. This standard emphasises quality management systems in the production of medical devices and has received official recognition under the International Accreditation Forum (IAF) Multilateral Recognition Arrangement (IAF MLA).

In Uzbekistan, both state-owned and private enterprises, ranging from large corporations to small businesses, are engaged in manufacturing of medical equipment. The quality of these medical products has a direct bearing on public health, making the production of safe medical devices a fundamental governmental responsibility in safeguarding consumer rights.

 

 

A comprehensive set of legal instruments governing product safety has been developed and implemented in Uzbekistan. Currently, the state register indicates that over 100 types of medical products are manufactured within the country.

Prior to the establishment of the national accreditation body for certifying management system certification bodies for medical device manufacturers, products had already been evaluated by certification bodies against established standards. The training of experienced assessors and the creation of a qualified service that complies with ISO 13485 are essential tasks within the National Accreditation System today.

Moreover, the push for competitiveness and quality within the industry has led to an expansion of accreditation services. In this regard, O’ZAKK has collaborated with leading accreditation bodies in the Asia-Pacific region, including the Korea Accreditation Board (KAB), achieving favorable outcomes. The qualifications of Uzbek assessors have been significantly enhanced through participation in various international training programs.

 

 

As part of a pilot project, one certification body has successfully obtained accreditation and is currently conducting audits to issue certificates of conformity to medical device manufacturers. Additionally, two more certification bodies are undergoing the accreditation process for this standard.

This progress signifies an improvement in the qualifications of Uzbek assessors and the introduction of new directions within the field. It not only fosters increased competition in the domestic market but also expands the options available to manufacturers.

Furthermore, the certification of accredited management systems serves as an effective mechanism for protecting the interests of consumers, regulators, and the broader public, particularly in the healthcare sector.