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

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: info@omcmedical.co.uk