Determine the product category
Food, medical devices and cosmetics fall under different filing systems and regulatory requirements.
For food, medical device and cosmetics companies
FDA Registration
Based on product attributes, manufacturing facilities, brand ownership and your role in the US market, we help determine the applicable facility registration, establishment registration, product listing, US agent and ongoing update requirements, keeping filings consistent with your real business.
- Preliminary regulatory category assessment
- Manufacturer and brand responsibility mapping
- English filing document review
- Renewal and change milestone reminders
The exact filing scope, official fees, service timeline and ongoing obligations depend on your product category, company role and current official requirements.
Confirm the responsible party
Clarify the actual relationship between brand owner, manufacturer, facility, importer and US contact.
Keep information consistent
Unify the key English details across company name, address, product name, model and label.
Regulatory Path
Different products, different filing paths
FDA registration is not a single universal certificate. The systems, filing parties, product information and maintenance cycles can differ across food, medical devices and cosmetics.
Food and dietary supplements
Focus on the actual manufacturing, processing, packing or holding facilities, and the US agent arrangement for overseas facilities.
- Food facility registration information
- US agent details for overseas facilities
- Company name, address and activity type review
- Biennial renewal and change reminders
- Product labelling and other obligations assessed separately
Medical devices
Establishment registration and device listing depend on device class, product code, manufacturer, specifications and your responsibility role in the US market.
- Preliminary device class and product code review
- Manufacturer and specification developer role review
- Establishment registration and listing preparation
- US agent details for overseas companies
- 510(k), De Novo and PMA assessed separately
Cosmetics
Under the MoCRA framework, we map the relationship between facility, responsible person, brand and product, and prepare facility registration and product listing information.
- Cosmetic facility registration information
- Product listing and responsible person details
- Brand name, product category and ingredient information
- Facility updates and registration renewal reminders
- Labelling and serious adverse event duties to monitor
Service Scope
Starting from business facts to reduce information mismatch
Product and use pre-screening
Understand product name, intended use, ingredients or structure, specifications, user group, sales channels and marketing wording, to identify the likely regulatory category.
Entity and facility relationship mapping
Confirm the business relationship between the applicant, actual manufacturer, packing or holding facility, brand owner and the US import or contact party.
English information consistency review
Unify the English company name, address format, contact, product name, brand, model and other filing fields, reducing follow-up work caused by inconsistent translations or legacy documents.
System submission and record retention
After the service scope is confirmed, prepare and submit information, and organise retainable account, submission or result records for later reference and maintenance.
Renewal, update and change reminders
For applicable categories, we flag annual registration, biennial renewal, listing updates, company relocation, contact changes or discontinuation matters that may need handling.
Linking related compliance items
Where needed, we connect US company formation, trademarks, barcodes, notarisation and apostille, bank accounts and tax compliance, keeping market entity information consistent.
Document Readiness
Common documents for an initial assessment
You do not need to submit everything at once. Start with the basic information that explains the product, factory and business relationship, then add documents according to the confirmed regulatory path.
Company entity documents
Company name in Chinese and English, certificate of incorporation or business licence, registered address, operating address, contact and phone number.
Factory and facility information
Address of actual manufacturing, processing, packing or holding, facility activity type, and the relationship between the factory and the brand owner or applicant.
Product technical information
Product name, category, use, ingredients or materials, specifications, product photos, instructions, label and packaging information.
Historical filing records
Existing registration numbers, account information, product listings, past submissions, company or address change records and related official correspondence.
Process Control
A clear, traceable process
From the first assessment to delivery of results, each step revolves around product classification, entity information and filing records, with timely updates whenever a key point needs your confirmation.
Information intake
Collect basic information on product, factory, brand and US sales arrangements.
Path assessment
Confirm your company role, product category and the specific items to be handled.
Document review
Unify company name, address, contact, model and product description.
Filing progress
Submit within the confirmed scope and keep you updated on supplements, confirmations and progress.
Result delivery
Organise results and retainable records, and note follow-up update and maintenance milestones.
Project records you will receive
Scope confirmation
A clear list of the registration, listing, agent or information update items included.
Progress feedback
Stage-by-stage feedback at document supplement, information confirmation and submission milestones.
Retained results
Retainable result information with an explanation of renewal or change requirements.
Service Principles
Important information clarified before we start
Filing based on real documents
Filing content must be consistent with the company, facility, product and actual operating situation.
- No fabricated company, factory or contact information
- Registration numbers are never described as product approval or official endorsement
- No guarantee of official review outcome or a fixed completion date
- Pause and verify first if product classification or documents conflict
Clear service boundaries
Registration, listing, US agent, label review, premarket submission, testing, quality system and import clearance are not the same service.
- Confirm exactly which items this engagement covers
- Official fees and third-party fees are itemised
- Testing, certification or technical files are confirmed separately
- Renewal and change responsibilities are explained in advance
Compliance note: FDA facility registration, establishment registration, product listing or a registration number is generally not equivalent to FDA approval, certification or endorsement of a product. Whether a medical device needs a premarket submission, and whether food or cosmetics involve additional labelling, ingredient, testing, reporting or import requirements, must be assessed separately for each product.
Practical Reading
Worth reading before entering the US market
FAQ
FDA registration: frequently asked questions
These are common questions before filing. Final conclusions still depend on your product, factory, company role and the latest official requirements.
Does an FDA registration number mean my product is FDA approved?
Generally not. Facility registration, establishment registration or product listing are mainly for regulatory identification and information management, and must not be described as FDA approval, certification, endorsement or a product quality guarantee.
Can a factory in China file directly?
Whether an overseas company can file, and what US agent or contact information is required, depends on the product category and the company's role in the supply chain. The actual manufacturing, packing, holding and brand relationships should be reviewed first.
For a trading company and a factory, who should be the registrant?
It cannot be decided by who pays alone. The registrant should be confirmed based on the regulatory definitions of facility, manufacturer, specification developer, responsible person or other roles, together with the real production and sales relationships.
After food registration, can the product be exported to the US directly?
Food facility registration is only one of the relevant obligations. The product may also involve labelling, ingredients, prior notice, importer verification, specific product permits or other requirements, which must be assessed per product and supply chain.
After device listing, is a 510(k) still required?
Establishment registration and device listing do not replace premarket authorisation. Whether a device is exempt or requires a 510(k), De Novo or PMA should be assessed based on its class, product code, intended use and technical characteristics.
Must all cosmetics complete facility registration and product listing?
Under the MoCRA framework there are facility registration, product listing and related update obligations, and there may also be applicable conditions or exceptions. Each item should be judged by company size, product and activity type.
Is maintenance needed after registration is complete?
Usually yes. Different categories may involve annual registration, biennial renewal, product listing updates, company address changes, agent changes or discontinuation information handling.
Why can't the timeline and fees be quoted uniformly?
Product category, company role, number of filings, historical accounts, official fees, whether a US agent is needed and whether a premarket submission is involved all affect the scope of work, so a quotation should be confirmed after the initial review.
Can I file without a US company?
Some overseas companies can file according to their category, but a US agent or US contact may be required. Whether to form a US company should be judged together with sales, collections, platform onboarding and tax arrangements.
I already have an old registration number — can I simply renew it?
The original account, registrant, facility address, contact, product status and historical filing information should be reviewed first. If the entity or key information has changed, an update or a reassessment of the handling approach may be required first.
Confirm the product path, then prepare the filing documents
Tell us the product name, intended use, factory location, brand ownership and planned sales channels, and our consultant will help map the possible registration, listing, US agent and follow-up maintenance items based on the information available.
You may also submit product details and contact information on the contact page.
