Recognition of the Term “REF” through a Supplementary Label
Resolution
Although RTCR 505:2022 does not recognize or authorize the use of the term “REF” to fulfill the requirement of the product identification code, it is permitted to clarify through a supplementary label that the “REF” indicated by the manufacturer corresponds to the product identification code, in accordance with Section 19.1.5 of the RTCR.
It is authorized to include the following statement on the supplementary label:
“Code: read on the original label REF as the product code.”
This clarification ensures compliance with national regulations and allows users to correctly identify the required information.
Key Aspects
- The regulation requires that only the official expression “product identification code” be used on labeling. The term “REF” is not contemplated as a valid designation for this requirement.
- The term “REF” is widely used by international manufacturers and accepted by various regulatory authorities, including the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), the European Union under Regulation (EU) 2017/745 (MDR), Health Canada, and Japan’s Pharmaceuticals and Medical Devices Agency (PMDA).
- Despite its global recognition, the nomenclature “REF” does not coincide with the mandatory terminology established under RTCR 505:2022.
- The supplementary label may be used to incorporate mandatory information not clearly indicated on the original label, allowing clarification that “REF” corresponds to the product identification code required under national regulations.
Use of a Supplementary Label to Clarify the Origin of Inputs in Biomedical Devices
Resolution
In accordance with RTCR 505:2022 “Biomedical Equipment and Materials: Classification, Registration, Importation, Labeling, Advertising, Surveillance and Control,” Executive Decree No. 43902-S, and in order to ensure proper interpretation of labeling for biomedical equipment and materials marketed in the country, the following is established:
In cases where the original label states “PRODUCT OF XXXX” or similar phrases, it is authorized to include the following statement in the supplementary label:
“Read on the original label PRODUCT OF XXXX as the origin of the raw material.”
It is also appropriate to include:
“Origin of the raw material: XXXX.”
This indication does not modify or correct the manufacturer’s original label but clarifies its meaning and distinguishes between the country of the manufacturer—which must be mandatorily declared—and the origin of its inputs.
Key Aspects
- Internationally distributed products often include statements such as “PRODUCT OF XXXX” or similar wording.
- These statements do not replace the requirement to identify the country of the manufacturer under RTCR 505:2022.
- In practice, such phrases usually refer only to the origin of a raw material, component, or bulk material used in manufacturing.
- This does not contravene the regulation, provided that mandatory manufacturer information is clearly included and differentiated.
- To avoid misinterpretation, the supplementary label should clearly indicate that the reference corresponds solely to the origin of the raw material.