There is a group of products that combines high demand, a good margin and a loyal following: those that look after the body, health and the home. LED masks, hair removal devices, beauty equipment, straightening brushes, cosmetics, cleaning products. China makes all of it at scale and at an inviting price, and it is natural for an importer to get excited. What they need to know before placing the order is that these products have a gatekeeper: the national health surveillance agency, ANVISA.
ANVISA does not exist to get in the importer’s way, but to ensure that what touches the consumer’s body and health is safe. Understanding how it works turns a frightening obstacle into a predictable process, and it is what separates those who build a solid business in these categories from those who take a loss at the first inspection.
What ANVISA regulates
ANVISA oversees products with an impact on health, and they fall into a few broad families. If your product fits one of them, sanitary compliance is part of the import:
Make-up, skincare, perfumery, hair and nail products: everything applied to the body for hygiene or beauty.
Medical equipment, beauty devices, dental and laboratory products: the items used in procedures, of higher risk and higher ticket.
Cleaning products, disinfectants and the like: what sanitises spaces and surfaces also goes through health surveillance.
Food and supplements, often alongside MAPA, with their own rules for registration and import by category.
Several finds featured in our China Showcase are in these families: the LED face mask, the IPL hair removal device, the skincare tools, the beauty equipment and the dental chair. All with an excellent margin, all under ANVISA’s screen.
Registration or notification: the risk yardstick
ANVISA does not treat every product with the same rigour. It uses the risk level to decide how much it demands, and that sets the route, the timescale and the cost of compliance. Broadly, there are two routes:
- Notification or listing: the simpler route, for lower risk products. The company notifies ANVISA of the product, with the required documentation, in order to be able to sell it.
- Registration: the fuller route, for higher risk products. It involves a technical dossier and analysis by the agency before approval, with a longer timescale and stiffer requirements.
| Family | Lower risk | Higher risk |
|---|---|---|
| Cosmetics / hygiene | Notification (grade 1) | Registration (grade 2) |
| Health devices | Notification / listing (lower classes) | Registration (higher classes) |
| Sanitising products | Notification | Registration |
A simple face serum and a beauty device that delivers energy into the body sit at opposite ends of that yardstick, and so they follow very different routes. Establishing the correct classification of the product is the first step, and one of the things people most often get wrong on their own.
Two levels: the company and the product
Here is the point that usually catches the importer by surprise: it is not enough to make the product compliant, the company also has to be authorised. They are two distinct levels of requirement that travel together.
At company level, importing and selling products under health surveillance usually requires the operating authorisation (AFE) from ANVISA and a health licence from the local authority, plus, in certain cases, a technical officer. At product level, each item needs its own registration or notification. Without both, the operation does not stand up: an authorised company without a compliant product cannot sell that item, and a compliant product held by a company without authorisation cannot be imported.
Why many import through a partner: building the sanitary structure, the AFE, the licence, the technical officer, and running each registration, is expensive and slow. Operating through someone who already holds that authorised structure, as in importing through a third party, shortens the route and reduces the risk, especially for anyone starting out in these categories.
A label in Portuguese, and responsibility
A health or beauty product has to reach the consumer with a label in Portuguese, carrying the mandatory information, the composition, the precautions and the details of the party responsible in Brazil. This is not a cosmetic detail: a product labelled only in Chinese, without the required information, is non-compliant, however good the formula may be.
And there is the point that own branding makes even more direct: whoever appears as responsible on the label is the party accountable to ANVISA. The Chinese factory supplies the formula and the test reports, but legal responsibility for the product in Brazil lies with whoever imports it and puts their name on it. A foreign certificate, on its own, makes nothing compliant here.
What happens without compliance
Skipping ANVISA does not save money, it postpones a bigger loss, and the risk shows up at two moments:
At customs: importing products under health surveillance depends on ANVISA’s clearance in the licensing process. Without compliance, the licence is not granted and the cargo is held at clearance, generating cost and delay.
On the market: selling a health product or cosmetic without registration or notification exposes the company to seizure, closure and fines, besides the risk to the consumer’s health and to your name. These categories are closely policed, including on marketplaces.
Compliance kept up to date, by contrast, is a selling asset: it reassures the customer, the marketplace and the clinic buying your equipment, and becomes a differentiator against the competitor selling non-compliant product. Combined with a good pre-shipment inspection, it ensures that the compliant product is the same one that reaches your warehouse.
How BCVN runs the compliance process
Sanitary compliance is the kind of subject that makes many people give up on an excellent category for fear of the paperwork. BCVN takes that weight off: we classify the product into the right family and risk level, saying from the outset whether it goes by notification or by registration; we coordinate the technical documentation, the formula and the test reports with the factory; we structure the operation with the sanitary authorisation needed; we handle the labelling in Portuguese and we run the compliance and the import through to release, without the cargo getting stuck at customs.
In practice, you choose the cosmetic, the beauty device or the health product you want to bring in, and we make sure it enters and sells within the law. That is what makes it safe to explore China’s highest margin categories, whether for resale or for your own brand. That is 18 years helping Brazilian importers navigate compliance and bring health and beauty products from China without scares. See also when a product requires INMETRO and the guide on how to import from China.
Frequently asked questions about importing under ANVISA
Which products imported from China need ANVISA approval?
All those with an impact on health. The broad families are cosmetics and personal hygiene and perfumery products, health products and medical and beauty equipment, sanitising products (cleaning products and disinfectants) and food, the latter often alongside MAPA. If the product is applied to the body, used in a health or beauty procedure, comes into contact with food or serves to sanitise spaces, it is probably regulated by ANVISA and needs compliance before being imported and sold.
What is the difference between registration and notification at ANVISA?
The difference is the risk level of the product. Lower risk products usually take a simpler route, notification or listing, in which the company notifies ANVISA of the product. Higher risk products require registration, a fuller process, with a technical dossier and analysis by the agency before the product can be sold. For example, a lower risk cosmetic tends towards notification, while a higher risk medical device requires registration. The correct classification determines the route, the timescale and the cost.
Do I need company authorisation (AFE) to import health products or cosmetics?
Generally, yes. To import and sell products subject to health surveillance, a company usually needs an operating authorisation (AFE) from ANVISA and a health licence from the local authority, besides the registration or notification of each product. There are two levels: authorisation of the company and compliance of the product. Without both, the import does not stand up. That is why many importers operate through a partner who already has the necessary sanitary structure, rather than building it all from scratch.
Who is responsible for ANVISA compliance?
The importer, as the holder of the compliance in Brazil. The Chinese factory supplies the technical documentation, the formula and the test reports, but the registration or notification is made in the name of the Brazilian company that will import and sell, which becomes the party accountable for the product. A foreign certificate does not replace Brazilian compliance. With an own brand this is even more direct, because it is your name on the label and your responsibility before ANVISA and the consumer.
What happens if I import a product subject to ANVISA without compliance?
The product may be held at clearance, because importing items under health surveillance depends on ANVISA’s clearance, and without compliance the licence is not granted. On the market, selling a product without registration or notification exposes the company to seizure, closure and fines, besides the risk to the consumer’s health and to your name. Health products and cosmetics are closely policed, and the cheapness of skipping compliance usually turns out very expensive.