In Bolivia, each agency develops technical regulations for the products in the areas that it oversees. Manufacturers, importers, and service providers must demonstrate compliance with relevant technical regulations prior to marketing the good or service. This can be done with the certificate of conformity issued by an accreditation body certified by the NMAC (The National Certification and Standardization Organization) System. U.S. testing laboratories do not operate in the Bolivian market. The manufacturer or importer must submit these certificates to the purchaser or distributor.
Three institutions are responsible for the approval of technical standards, metrology, and accreditation: the Bolivian Institute of Normalization and Quality (IBNORCA), the Bolivian Institute of Metrology (IBMETRO), and the Technical Directorate for Accreditation (DTA).
IBNORCA is responsible for the technical standardization and the certification of products and quality systems. It is a private, non-profit organization, representing Bolivia in all relevant international organizations. It is a correspondent member of International Organization for Standardization (ISO). IBNORCA is a member of the International Electrotechnical Commission (IEC), the Pan-American Standards Commission (COPANT), the Mercosur Committee for Standardization (CMN), and of the Andean Committee for Standardization of the Andean Group (CAN). Furthermore, Bolivia is a member of the World Trade Organization Agreement on Technical Barriers to Trade.
IBMETRO is responsible for the custody and maintenance of national measurement standards to the International System of Units (SI), and the dissemination of accurate patterns through their services. In addition to these functions, the IBMETRO is responsible for: the technical competence of institutions involved in conformity assessment implementation, government policies to support scientific and technological development, and developing and strengthening a national system of metrology in line with international practices. The IBMETRO reference laboratories are where metrology and calibration proceedings are carried out, and where the prototype meter, kilogram, and other standards are stored. IBMETRO has regional offices that oversee services in legal metrology to the public.
The DTA is a public body responsible for managing accreditation of conformity assessments throughout the country. The National Institute of Health Laboratories (INLASA) coordinates the quality assessment program for the Bolivian laboratory service network. INLASA also standardizes technical procedures for laboratory diagnosis during the preparation of biological products (vaccines, PPD, etc.).
Testing, Inspection and Certification
Products coming from the United States can easily enter Bolivia if suppliers receive all information regarding the products’ composition and components in advance. The NMAC works according to a regulatory framework like that of the United States. Under the NMAC system, products or services falling under a specific technical regulation must meet its standards, whether they are produced in Bolivia or are imported. In the absence of national technical regulations, the products or services must comply with the technical rules of the country of origin.
Publication of Technical Regulations
IBNORCA is the office responsible for publishing voluntary standards and notifying private and public organizations of those standards. Mandatory standards are issued by supreme decrees and are published in the official Bolivian government gazette www.gacetaoficialdebolivia.gob.bo. In most cases, stakeholders have an opportunity to provide comments during the drafting phase. Generally, the public is given six months to comment, but the Bolivian government does not always adhere to set timelines.
Servicio Nacional de Seguridad Alimentaria y Agropecuaria (SENASAG) https://www.senasag.gob.bo
Ministry of Health and Sports’ Medicines and Health Technology Unit (UNIMED)
Instituto Nacional de Laboratorios de Salud (INLASA) https://www.inlasa.gob.bo
The National Certification and Standardization Organization (IBNORCA) https://www.ibnorca.org
IBMETRO and DTA http://www.ibmetro.gob.bo/web/gestion_dta
National Intellectual Property Service - SENAPI ttps://www.senapi.gob.bo
Animal and Plant Health Inspection Service (APHIS) https://aphis.usda.gov
Aduana Nacional https://www.aduana.gob.bo/aduana7/
Standards Attaché – Brazil, Jeff Hamilton Jeff.Hamilton@trade.gov
Use ePing to review proposed technical regulations and conformity assessment procedures
The ePing SPS&TBT platform (https://epingalert.org/), or “ePing”, provides access to notifications made by WTO Members under the Agreements on Sanitary and Phytosanitary Measures (SPS) and Technical Barriers to Trade (TBT), distributed by the WTO from January 16, 1995 to present. ePing is available to all stakeholders free of charge and does not require registration unless the user wishes to receive customized e-mail alerts. Use it to browse notifications on past as well as new draft and updated product regulations, food safety and animal and plant health standards and regulations, find information on trade concerns discussed in the WTO SPS and TBT Committees, locate information on SPS/TBT Enquiry Points and notification authorities, and to follow and review current and past notifications concerning regulatory actions on products, packaging, labeling, food safety and animal and plant health measures in markets of interest.
Notify U.S., operated and maintained by the National Institute of Standards and Technology (NIST) since 2003 to distribute and provide access to notifications (and associated draft texts) made under the WTO TBT Agreement for US stakeholders, has reached its end of life. Per obligation under the TBT Agreement, each WTO Member operates a national TBT (and an SPS) Enquiry Point. National TBT Enquiry Points are authorized to accept comments and official communications from other national TBT Enquiry Points, which are NOT part of the WTO or the WTO Secretariat. All comment submissions from U.S. stakeholders, including businesses, trade associations, U.S domiciled standards development organizations and conformity assessment bodies, consumers, or U.S. government agencies on notifications to the WTO TBT Committee should be sent directly to the USA WTO TBT Inquiry Point. Refer to the comment guidance at https://tsapps.nist.gov/notifyus/data/guidance/guidance.cfm for further information.