Located in Central Asia, the Republic of Tajikistan is a mountainous, landlocked country, bordered by Afghanistan, Uzbekistan, Kyrgyzstan and China. A presidential republic comprising four provinces, it spans over 140 000 km2 and is home to more than 8 million people. Tajikistan is a member of the Commonwealth of Independent States (CIS), made up of former Soviet states.
The population in Tajikistan is young and growing rapidly, with more than half of the country below 25 years old. Such demographic shifts are dictating the direction of the government, which is focused on reforming the critical agriculture sector, reducing poverty, creating jobs, and improving public services such as healthcare. The economy has been steadily growing in recent years, increasing by 6.7% in 2014 according to the World Bank. However, the country’s economy is closely tied to that of Russia, and may be vulnerable to shocks in the market as Russia experiences economic turmoil. Though Tajikistan is a member of CIS and has signed a free trade agreement for the region, it is not among the members to have ratified the agreement to date.
Healthcare expenditure has been increasing, totaling 4.3% of the country’s GDP in 2005 and 5.8% in 2012 (or USD $129 per capita) according to the World Health Organization; the vast majority of healthcare expenditure is from the private sector (including out-of-pocket), with developmental assistance funds playing a significant role as well. Tajikistan is still in the process of transitioning out of the Soviet-era healthcare model, and their health system remains underdeveloped, with indicators placing the country among the lowest rankings for healthcare in the region. Serious health problems exist, including low life expectancy, high infant mortality rate, and prevalence of communicable diseases such as tuberculosis. However, the country’s government has recognized this need and is increasing public healthcare expenditure and altering funding structures over the past fifteen years to include co-payment schemes and other initiatives to meet the demand for services.
In December 2014, the Eurasian Economic Union (EEU), which includes Russia, Kazakhstan, Belarus, and Armenia (but not yet Tajikistan), signed a harmonization agreement for pharmaceuticals and medical devices set to come into force in early 2016. This is the latest trend toward harmonization and cooperation in the CIS, of which Tajikistan is a member. As such, Tajikistan may adapt its regulations to the forthcoming standards or be included in the agreement in the future as its membership in EEU is currently under negotiations.
THE GOOD NEWS:
While technical documents must be submitted in Russian, labelling can be in any major language such as English, Spanish, or French.
The grouping and classification of devices based on intended use must be selected carefully to avoid delays with authorities in Tajikistan.
Medical devices in Tajikistan are regulated under the Service of the State Supervision of Pharmaceutical Activities of the Ministry of Health. Tajikistan classifies medical and IVD devices according to the same standards as the EU, though they are grouped by class and intent of use. The registration system is similar to that of Kazakhstan, and as such, it is easier to complete than the process in Russia (for example).
For foreign manufacturers, license applications must be submitted through a local agent, who must be registered with the authorities and hold power of attorney. The manufacturer, importer, or distributor may be the official license holder, but only the official license holder may transfer the license to another entity. More than one distributor is permitted.
A Good Manufacturing Practice (GMP) certificate and ISO 13485 and ISO 90001 certification must be included in the technical dossier, along with a Certificate of Free Sale from the country of origin. An audit inspection of the manufacturer’s site may be required, but in most cases, a Quality Management Systems (QMS) certificate is sufficient. In addition, devices that have measurable function should provide a calibration certificate and scanned copies of the relevant test results. All documents must be submitted in both hard and soft copy, and in the language of the importer as well as Russian.
Registration can be completed in two to six months from the time of submission (depending on the class of device), or one month for Class I and non-sterile devices. Once issued, a license is valid for five years.
WHAT YOU NEED TO KNOW:
Registration in Tajikistan is comparable to the process in Kazakhstan, meaning it is simpler than Russian registration. A CE Mark is required. Technical documents should be submitted in Russian and registration can be complete in one month for Class I devices, or between two and six months for other device types.