1. What is RDC 488/2021 and its Purpose?
RDC 488/2021 was established to regulate the importation of health products subject to sanitary surveillance by healthcare units, aiming to address specific needs in patient care, diagnosis, treatment, and rehabilitation.
Key aspects of the resolution include:
- Ensuring that imported products are exclusively for the internal use of healthcare units.
- Prohibiting the transfer, resale, or distribution of imported products.
- Establishing clear rules for exceptional cases involving products not registered with ANVISA.
2. Who Can Import and Under What Conditions?
The importation governed by RDC 488/2021 can be performed by:
- Healthcare Units: Hospitals, clinics, and other institutions focused on medical assistance.
- Foundations and OSCIPs: Provided they are directly linked to a healthcare unit.
- Health Plan Operators and Public Entities: Exclusively for the use of the units they manage.
Important conditions:
- Importation must be conducted independently, by order, or by third-party commission, as regulated by RDC 81/2008.
- All imported products must be properly licensed in SISCOMEX.
Permitted Modalities:
- Direct import: When the health unit itself carries out the process.
- On behalf of and at the order of third parties: By contracting a qualified importer.
- By order: Involving entities linked to the health unit.
3. Required Documents for the Importation Process
To proceed with importation, the following documents are essential:
- Proof of regularization with ANVISA or special authorization for unregistered products.
- Health license or sanitary permit for the healthcare unit, issued by the competent authority.
- Authorization for Company Operations (AFE): Required for service providers handling imports.
- Commercial contract between the healthcare unit and the importer.
- Declaration from the registration holder: Ensuring exclusive use by the healthcare unit, valid for up to 90 days.
- Import License (LI): Issued by SISCOMEX.
Electronic document submissions require a digital signature with an ICP-Brasil certificate to ensure security and authenticity.
4. Exceptions: Non-Registered Products in ANVISA
RDC 488/2021 allows for the exceptional importation of non-registered products, provided the following conditions are met:
- Unavailable in the national market: The equivalent product is not available in Brazil.
- Technical and scientific justification: The healthcare unit must present a report demonstrating the necessity of the product and the absence of alternatives.
- Registration in the country of origin: Proof of registration or commercialization in the manufacturing country is required.
If the product has been previously authorized by ANVISA, the request analysis may be expedited based on prior decisions.
5. Impacts and Benefits of RDC 488/2021
This resolution offers significant benefits, such as:
- Flexibility in addressing clinical demands: Especially in emergencies or supply shortages.
- Product safety: Stringent rules ensure quality and traceability.
- Simplified importation process: Centralized in SISCOMEX and aligned with international standards.
However, strict adherence to the rules by all parties involved is crucial to avoid sanitary violations and ensure compliance.
Conclusion
RDC 488/2021 represents a major advancement for the healthcare sector, balancing speed and safety in product importation. For healthcare units and regulatory professionals, understanding and correctly applying the guidelines of this resolution is essential to providing quality medical care while adhering to legal requirements.
If you wish to learn more about implementing RDC 488/2021 in your professional context, consult experts or access the full text of the resolution here.
📝 Access RDC No. 488/2021
The text in the original language of this announcement is the only official and authorized version. Translations are provided solely for convenience and should refer to the original language text, which is the only version with legal effect.
For any questions, please contact Brisa Advisors for specialized regulatory support
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