Bolivia Medical Device Registration
Navigating Bolivia’s Medical Device Import Regulations: AGEMED Guidelines, Registration Process
Regulatory Authority
La AgenciaEstatal de Medicamentos y Tecnologíasen Salud – AGEMED
AGEMED, a regulatory authority in Bolivia, promotes and protects the health of the Bolivian population through legality, impartiality, coherence, effectiveness, efficiency, equity, clarity, transparency, and respect for diversity. It strengthens health control through registration, surveillance, inspection, and rational use for access to effective, safe, and quality medicines and technologies.
The agency’s objectives include strengthening the Agency’s governing capacity, implementing the Single Supply System, encouraging the production, registration, and marketing of natural products used in traditional medicine, facilitating advice to artisanal producers and microenterprises, forming pharmacy and therapeutics committees, strengthening community pharmacies, developing the Pharmaceutical Profile of Bolivia, training pharmacy staff, disseminating information, reducing illicit medication marketing, strengthening the management of CEASS Health Supply Central, harmonizing pharmaceutical regulations, prioritizing quality control, and promoting the national industry for generic and essential medicines production.
Link for Regulatory Authority
https://www.agemed.gob.bo/
Local Regulation
Bolivian medicines law (Law No. 1737), Bolivian Health Registration Manual
Classification of Medical Devices
class I, class IIa, class IIb, class III
Listing or Registration Requirements
In Bolivia, there are registration requirements only for MDs that get in touch with the body and capital equipment like Biomedical equipment and accessories.
Documents Required for Registration
1) Legalized Quality Certificate
2) FSC (original &apostilled)
3)Description of parts/components
4)Analysis Certificate of finished products, complying with certified
5) Shelf life
6) Storage conditions
7) GMDN code
8) Classification according to risk
9) Efficacy and security info (usually available in Risk Analysis files)
10) IFU
11) Sterilization info (e.g. Sterilization Validation Report)
12) Primary and secondary packaging Labels, Sample (NOT mandatory, only required in Class I products).
Registration Timeline
1. 6 to 12 months to review new products 2.1 month to review essential products
License Validity
5 Years
License Renewal
Re-registration process must be submitted as far as possible within three months before the expiration of the Sanitary Registry.
Special Labelling Requirements
Labelling must be in Spanish
Who should make this Communication?
- Manufacturer
- Authorized Representative
Bolivia – Import Requirements
To comply with product registration regulations in Bolivia, your company must possess the following documentation for the importation and marketing of a product in the country:
- Authorization for product transportation via sea or air
- Numbered inventory of all products being shipped to Bolivia
- Declaration incorporating the product values
- Health certifications, if mandated
- Document indicating the merchandise origin for the application of distinct tariff agreements
- Customs tax estimate
- Value-added tax calculation
Bolivia Trade Regulations
Bolivia permits the importation of medical devices and pharmaceutical products, subject to adherence to standard importation duties, taxes, and the requisite registration procedures. Importers dealing with such products are obligated to comply with established regulatory protocols to ensure the lawful and safe entry of these goods into the country.
In accordance with Bolivian regulations, importers must fulfill their responsibilities regarding customary import duties and taxes applicable to medical devices and pharmaceutical items. This includes adherence to the stipulated registration process, a crucial step in facilitating the entry of these products into the Bolivian market.
The importation of medical devices and pharmaceutical products is closely monitored to uphold the safety, quality, and efficacy standards mandated by Bolivian authorities. Compliant importers contribute to the overall integrity of the national healthcare system by ensuring that imported medical and pharmaceutical goods meet the necessary regulatory criteria.
By following the prescribed importation procedures and meeting regulatory obligations, importers play a vital role in fostering the accessibility and availability of critical healthcare products within Bolivia’s borders.
When to make this Communication?
Before placing a medical device into the market.
How OMC Medical can assist you with the Process?
- Act as your Authorized representative
Why Choose Us?
- Working towards client satisfaction
- Cost effective solutions
- Project completion before deadline
- Quality Regulatory affairs solutions
Contact us for free consultation: sales@omcmedical.com
Frequently Asked Questions
The Agencia Estatal de Medicamentos y Tecnologías en Salud (AGEMED) is responsible for regulating medical devices in Bolivia. It oversees product registration, market surveillance, inspections, and compliance with applicable health regulations.
Bolivia classifies medical devices into four risk-based categories: Class I, Class IIa, Class IIb, and Class III. The classification depends on the device's intended purpose and associated risk.
Registration requirements apply to medical devices that come into contact with the human body and capital equipment, including biomedical equipment and accessories. Manufacturers should confirm the applicable requirements for their specific products with AGEMED.
The review of new medical device products generally takes 6 to 12 months. Essential products may have a shorter review timeline of approximately one month, depending on the applicable requirements.
A medical device sanitary registration certificate in Bolivia is valid for five years. Manufacturers or their representatives should initiate the re-registration process before the certificate expires.
Medical device labelling must be provided in Spanish to meet the applicable regulatory requirements. Manufacturers should ensure that product information and Instructions for Use are appropriately prepared for the Bolivian market.
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