Sterilization, Biocompatibility and Shelf-Life Evidence for Colombia

1. Key takeaways

Within the technical documentation system of Article 18 of Decreto 4725 de 2005, sterilization validation, biocompatibility and shelf life belong to one class of evidence: they do not describe what the product is, they prove that the product remains safe under specified conditions throughout its life. The GRZAN judgment is that the actual weight of these three sets of materials exceeds what applicants generally expect, because Colombia has no separate GMP on-site inspection as a routine prerequisite, so the reviewer’s judgment of process control rests mainly on these validation reports.

Controlled-technology biomedical equipment follows the Permiso de Comercialización route (Art. 23 and Art. 24), with a current fee schedule figure of 367.92 UVB, approximately COP 4,455,511; meanwhile the medical device registration certificate is uniformly valid for 10 years, so a shelf life shorter than that cycle triggers repeated changes during the life of the certificate.

2. Legal basis

3. Expert insights

#### 1. The validation materials carry such weight because they are the only verifiable process evidence

Under the current Colombian system, foreign manufacturers are generally not subjected to an on-site inspection for a single registration application. All the reviewer can read is paper. The sterilization validation report, the biocompatibility evaluation and the shelf life validation therefore perform a double function: they answer whether the product is safe, and they answer indirectly whether the manufacturing process is under control. GRZAN accordingly recommends building these reports as conclusion summaries with an annex index rather than filing raw reports alone, because the reviewer can extract the safety argument from the summary while the annexes remain available for detailed verification whenever needed.

#### 2. Standard citations must state the version, and they must be marked as a practical estimate

INVIMA has not designated specific standard versions in the current decree. International common practice is to organize the validation around the biocompatibility standard series, the ethylene oxide sterilization standards and the sterile packaging standards (practical estimate). GRZAN’s strategy is to state the name and version of each standard relied upon explicitly in the report, together with an applicability note explaining why the standard applies to this product. A report without versions hands the judgment to the reviewer, and a reviewer forced to guess the applicable standard will answer with a deficiency letter rather than with an approval.

#### 3. Shelf life is the only submission material that expires automatically with time

Sterilization validation and biocompatibility are relatively fixed once completed, but shelf life is continuously consumed. The registration certificate is valid for 10 years, and where the shelf life data cover only a shorter term, supplementary real-time aging data become necessary at renewal or change. GRZAN recommends starting the real-time aging study at first submission and keeping long-term and accelerated data in one ledger together, rather than waiting for the renewal window. Aging data cannot be compressed after the fact: the calendar needed to prove a ten-year claim must have started running years earlier.

#### 4. Controlled-technology equipment takes a different route, with different fees and a different dossier structure

Art. 23 and Art. 24 govern the Permiso de Comercialización for controlled-technology biomedical equipment, running in parallel with the Registro Sanitario. The current fee schedule lists this item at 367.92 UVB (approximately COP 4,455,511), close to but not identical with the 364.36 UVB for Class IIb/III registration. GRZAN warns that a wrong route decision leads to the entire dossier being prepared in the wrong structure, and the basis for the route decision remains the classification conclusion under Art. 6 and Art. 7 together with the technical attributes of the equipment. Correcting a route after filing costs a whole cycle; confirming it before filing costs a meeting.

4. Practical recommendations

1. Have GRZAN confirm the route at project initiation: equipment falling within controlled-technology biomedical equipment follows the Permiso de Comercialización of Art. 23 and Art. 24, while the rest registers under Art. 16 or Art. 17.
2. Have the foreign manufacturer provide the sterilization validation report stating the sterilization method, the name and version of the validation standards, and the argument for the sterility assurance level.
3. Have the toxicology assessor produce the biocompatibility evaluation covering the body-contacting sites, the nature of contact and the duration of contact.
4. Have the quality lead start the real-time aging study at first submission and maintain a reconciliation ledger of accelerated and real-time data.
5. Have the applicant budget the marketing permit fee of 367.92 UVB for controlled-technology equipment under the current fee schedule.
6. Have the registration specialist unify the Spanish renderings and the conclusion summary format of the validation reports before submission in SIRIS.

5. Verification checklist

• □ The route is confirmed: Permiso de Comercialización or Registro Sanitario
• □ The sterilization validation report states the sterilization method, the standard name and version, and the sterility assurance level argument
• □ The biocompatibility evaluation covers contact sites, nature of contact and duration of contact
• □ The shelf life data include both accelerated aging and real-time aging
• □ The validation reports carry an official Spanish translation and an applicability note
• □ The marketing permit fee of 367.92 UVB for controlled-technology equipment is in the budget
• □ The real-time aging study has started and can cover the 10-year validity of the certificate

Regulatory information verified as of October 29, 2026

All conclusions for external use are based on the current regulatory texts published by the competent authorities and are verified item by item before delivery.

GRZAN supports manufacturers entering the Colombian market with registration dossiers and conformity documentation, including sterilization validation packaging, biocompatibility evaluation coordination, shelf life and aging study planning, and route selection between registration and permit routes before INVIMA. For inquiries, contact info@grzanglobal.com.