Sanitary Registration
Sanitary Registration for Regulated Products
Health authority registrations for medical devices, cosmetics, personal care, and other sanitary-regulated products entering Latin America and other markets. Filed, followed, and maintained by ORBIS.
What a sanitary registration is
For health-regulated products, the health authority decides whether you may sell.
Medical devices, in vitro diagnostics, cosmetics, personal care products, disinfectants, and certain consumer health products are regulated by national health authorities rather than by telecom or electrical safety regulators. In many markets, especially across Latin America, those authorities require a sanitary registration before the product can be imported, distributed, or sold. The registration confirms the product's identity, classification, safety, and labeling, and it's tied to a local registration holder who is legally responsible for the product in that country.
The requirements vary widely. Some authorities accept approvals from reference countries such as the FDA, the EU, Health Canada, or Japan's PMDA as the basis for an abbreviated review. Others conduct full technical evaluations. Classification rules, dossier formats, labeling languages, stability data requirements, and validity periods differ from country to country, and the authorities update them regularly.
ORBIS Compliance manages sanitary registrations as part of our Product Certification service, with regulatory professionals who prepare the dossier to each authority's requirements, provide or coordinate the local registration holder, and follow the file through to approval and beyond.
Product categories
Products that typically require sanitary registration
Medical devices
From Class I consumables to active implantable and software-driven devices, registered by risk class with the technical documentation, quality system evidence, and labeling each authority requires.
In vitro diagnostics
Reagents, analyzers, and self-test kits, with performance and stability data reviewed under IVD-specific rules that many markets have recently tightened.
Cosmetics and personal care
Skin, hair, oral care, and fragrance products, registered or notified with ingredient lists, safety assessments, claims review, and labeling in the local language.
Disinfectants and hygiene products
Antimicrobial products for surfaces, hands, and equipment, often regulated as sanitary products with efficacy data and specific labeling obligations.
Connected and electronic health products
Wearables, monitors, and connected medical electronics that need sanitary registration alongside radio type approval and electrical safety certification.
Consumer health products
Supplements, medical foods, and borderline products whose classification determines the entire regulatory route and has to be settled first.
The critical decisions
Classification and the local holder decide most of the path.
The first decision in any sanitary registration is classification. Whether a product is a medical device or a general product, which risk class it falls into, and whether a software function changes that class determines the dossier, the review time, the fees, and sometimes whether the product can be registered at all. Getting classification wrong means either an unnecessary registration or a rejected import, and the answer isn't always the same from one country to the next.
The second decision is the registration holder. Most sanitary authorities require the registration to be held by a legal entity in the country. If that entity is your distributor, the registration belongs to them, and changing distributors can mean starting over. An independent local holder keeps the registration under your control. ORBIS provides local holder representation for exactly this reason.
ORBIS settles both decisions up front, with direct engagement with the health authority when the classification of a novel or borderline product isn't clear from published guidance.
How ORBIS manages the registration
From classification to a registration you can renew
- 1
Classify and plan
We confirm the product's classification and registration route in each market, and identify where reference-country approvals shorten the review.
- 2
Build the dossier
Documents are gathered, translated, legalized, and formatted to each authority's requirements, with gaps closed before submission.
- 3
File and respond
The application is submitted under the local holder, and authority queries are answered by regulatory professionals who know the product.
- 4
Maintain
Registration validity, labeling changes, manufacturing site changes, and regulatory updates are tracked in ORBIS Intelligent Compliance so the registration stays active.
Questions
Sanitary registrations
Our device has FDA clearance and a CE mark. Do we still need a sanitary registration?
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In most markets that require sanitary registration, yes. Reference-country approvals often qualify the product for an abbreviated or expedited review, but the national registration is still required and is still tied to a local holder. We map which markets offer reliance routes for your product.
How long is a sanitary registration valid?
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It varies by country and product category, from a few years to indefinite validity with periodic updates. Some markets tie validity to the reference approval. ORBIS tracks each registration's validity and the changes that trigger an update, so renewals aren't discovered late.
Can ORBIS act as our registration holder?
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Yes, in markets where we provide local holder representation. Holding the registration independently of your distributor keeps it under your control and simplifies changes in your commercial arrangements.
Get the registration that opens the market.
Bring the product, its classification, its existing approvals, and the countries on your list. We'll map the sanitary registration path for each and tell you where a local holder or local testing is required.
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