What this checklist is for

It is the pocket version of the guide to INVIMA sanitary registration: what procurement or clinical engineering should ask for and check at each stage of buying biomedical equipment, with the regulation behind each item.

Guidance for buyers; it does not replace regulatory advice. Regulations reviewed in September 2026.

When requesting the quote

  • Sanitary registration or marketing permit number for each model, in writing. Decree 4725 of 2005 (Article 16) requires it to import and sell the equipment.
  • Names of the registration holder and the importer. The registration is an authorization in a company's name (Article 2).
  • If the supplier imports the equipment, its Storage and Conditioning Capacity Certificate (CCAA). INVIMA issues it to importers and distributors that store and/or condition medical devices (Resolution 4002 of 2007), and it is valid for 5 years (Decree 4725, Article 15). A distributor that does not import and only stores and distributes does not need it.

When comparing offers

  • Registration checked in INVIMA's public database (Consulta avanzada): status, validity, holder, importer and manufacturer match the offer.
  • The quoted model or reference is listed under that registration. One registration can cover several models from the same holder and manufacturer (Article 28), but not every model of the brand.
  • Registration expiry date. Validity is 10 years (Article 31). If it expires during the contract, ask whether the renewal has been filed: it must be filed three months before expiry and keeps the number with the suffix R1, R2… (Article 32).
  • New, used or refurbished equipment, stated in writing. Used and refurbished equipment is covered by a marketing permit and has its own rules in Decree 4725 (Article 37).

When receiving the equipment

  • Spanish label with the product name, lot or serial number, expiry date where applicable, the registration or permit number and the manufacturer and/or importer with their address (Article 54). For imported equipment, also the name and address of the importer or the manufacturer's representative (Article 55).
  • Operating and maintenance manuals in Spanish. The holder or importer commits to INVIMA to deliver them at the time of purchase (Article 18, item h).
  • Serial number recorded together with the purchase date and supplier. The importer or distributor must also keep these data for traceability (Article 63).

After the purchase

  • Equipment added to the institutional technovigilance program, with its designated lead. Resolution 4816 of 2008 (Articles 9 and 10) requires it of healthcare providers.
  • A clear reporting channel. Serious adverse events and incidents are reported to INVIMA within 72 hours (Article 15); non-serious ones, in consolidated quarterly reports (Article 16).
  • A plan for when the registration expires. According to INVIMA's FAQ, if the equipment was sold before its registration or permit expired, the buyer may keep using it provided services such as calibration verification and maintenance are guaranteed. Build this into the support contract.

Something doesn't match?

Ask for a written explanation before signing. If you would like us to review a device's documentation with you, talk to an I-ME advisor.

Sources