The Ministry of Health issued an official notice clarifying the correct requirements applicable to notarized certifications and powers of attorney used in procedures involving products of health interest and sanitary risk.
- Notarized Certifications
The notice details the valid methods for certifying documents depending on their format:
a) Certifications in physical format:
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- Must be issued on security paper, with the notary’s signature and embossed seal.
- The notarial statement must include the notary’s full information, date, time, and type of certification.
- As of December 3, 2024, fiscal stamps are no longer required.
- For digital filings, the complete physical document must be scanned and digitally signed by the notary.
b) Certifications in digital format:
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- Applicable to both digitized documents and natively electronic documents.
- The official format must be used, including certified digital signature and timestamp.
- Physical seals are not required for digital documents.
- Electronic documents have full legal validity, equivalent to physical documents.
c) Documents obtained from the internet:
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- The notary does not certify the accuracy of the content, only what was observed at a specific moment.
- The certification must include: the complete website domain, date and time of access, and QR code content, if applicable.
- Powers of Attorney for Legal Representation
The power of attorney is the document used to grant representation to the local representative or agent. The format suggested in previous notices is merely a guideline and is not mandatory.
Key recommendations:
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- If the applicant is a legal entity, the power of attorney must be granted to the company, not to an individual.
- If applicable to affiliates or subsidiaries, these must be expressly listed.
- The power of attorney must include the minimum authorities required by the Ministry of Health.
Sanitary Classification of Sodium Chloride Nasal Solutions
The Ministry of Health also clarified the applicable sanitary registration category for nasal wash solutions containing sodium chloride, based on the product’s primary mechanism of action.
Classification criteria
Medical Device (Biomedical Equipment and Materials – EMB):
Applies when the product’s primary effect is physical (mechanical or osmotic cleansing), without pharmacological, immunological, or metabolic action.
Saline nasal solutions whose sole purpose is the mechanical cleansing of the nasal cavities must be registered as EMB.
Pharmaceutical Product:
Applies only when the product demonstrates a pharmacological, immunological, or metabolic effect supported by safety and efficacy studies.
Only products proving a therapeutic effect beyond the physical mechanism may be classified as medicines.
Products Already Registered
Products currently registered as pharmaceutical products, but whose effect is exclusively mechanical, must either:
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- Change their registration to EMB during the current validity period (cancelling the pharmaceutical registration), or
- Maintain the pharmaceutical registration until expiration, without the possibility of renewal under that category.
Accepted Uses as EMB Include:
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- Mechanical nasal washing.
- Post-surgical nasal washing.
- Adjunctive use in sinusitis, allergies, or other conditions.
Applicants remain responsible for defining and justifying the product category, without prejudice to the Regulatory Authority’s ability to request additional information during the evaluation process.
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