East Asia
Manufacturing in Korea for the Taiwanese Market
Taiwan used to sort cosmetics into two tiers, with sunscreens, whitening products and hair dyes carrying a licence the rest did not need. That structure is gone. Every cosmetic now takes one route — registered with the TFDA before it is supplied, with a Product Information File standing behind it — and the work has moved from arguing about which tier a product belongs in to making the file good enough to stand. Two things still single out a Korean range: the ingredient rules governing any sun protection claim, and a manufacturing practice obligation that reaches the Korean factory rather than stopping at your Taiwanese partner.
The framework
- Regulator
- Taiwan Food and Drug Administration (TFDA), Ministry of Health and Welfare
- Governing law
- Cosmetic Hygiene and Safety Act
- Before you can sell
- Product registration with the TFDA before supply, for every cosmetic. There is no longer a separate licensing tier above it.
- Must be established locally
- A business registered in Taiwan holding the registration.
- Sunscreen is
- No separate category, but the filters are governed — Taiwan publishes its own table and also accepts filters that the EU, the United States or Japan permit, used on those terms. A sun protection claim needs supporting evidence in the file.
From formula to first shipment.
- 01
Appoint the Taiwanese registration holder
The registration is filed and held by a business established in Taiwan. A Korean manufacturer cannot hold it. The tie carries more weight than the word registration suggests — the filing is the market access, and it sits with your Taiwanese partner rather than with you.
- 02
Check the formula against Taiwan’s lists
Taiwan maintains its own positions on prohibited and restricted substances, preservatives, colourants and sun protection filters. They resemble the EU and ASEAN lists in structure without matching them entry for entry. Check the Taiwan position directly rather than inferring it from either, and do it before packaging is tooled.
- 03
Register the product before it is supplied
Registration is a filing rather than an approval — there is no waiting for a licence to be granted. What replaces that wait is the expectation that the file behind the product is complete from the start, because the authority can ask for it at any point rather than at a gate you pass once.
- 04
Compile the Product Information File
The file holds the formula, the safety assessment, manufacturing and quality documentation, and the evidence behind whatever the product claims to do. Where the product carries a sun protection figure, the testing that supports it belongs here. It is held for the product and produced to the authority on request.
- 05
Meet the manufacturing practice obligation at the Korean site
Taiwan applies its cosmetic manufacturing practice requirement to overseas manufacturing sites as well as domestic ones. That puts the Korean factory inside the scope of Taiwanese market access rather than outside it, and it is the part of the file your Taiwanese partner cannot assemble on your behalf.
- 06
Prepare Chinese labelling
The label is in Chinese — Taiwan uses Traditional characters — or in internationally recognised symbols, covering product identity, net content, country of origin, batch and durability information, the holder’s details, usage and warnings. The full ingredient declaration may stay in English, which spares you one translation but not the rest of the artwork.
What catches brands out here.
Most guidance you will find describes a system that no longer exists
Search for Taiwan cosmetic requirements and you will be told that sunscreens and whitening products are specific-purpose cosmetics needing their own licence, with its own review and its own timeline. That tier was retired and the licensing rules behind it were repealed. Anyone quoting you a licence lead time for a Taiwanese sunscreen is working from stale material — and so is anyone budgeting for one.
Sun protection: the filter table is not a closed list
Taiwan publishes a table of permitted sun protection ingredients, but it does not stop there — a filter that the EU, the United States or Japan has published rules for is also usable in Taiwan when it is used on those terms. That is more room than a closed national list would leave, and more than most Korean formulations need. What does need attention is the claim: an SPF figure has to be backed by evidence sitting in the file.
Traditional Chinese is not Simplified Chinese
A label and copy set produced for mainland China does not transfer. The characters differ, and so does the vocabulary — the two markets use different words for the same ingredient and the same claim often enough that a mechanically converted file reads as imported from somewhere else. Budget a Taiwan copy pass rather than a script conversion.
Taiwan is not a rehearsal for the mainland
They are separate regimes with separate filings, separate labels and separate claim rules, and nothing prepared for one carries into the other. Taiwan is worth entering on its own terms. Treating it as a cheap trial run for a China programme produces documentation that serves neither market.
The manufacturing site is in scope, not just the importer
Most markets on this site aim their formal filings at the local entity and stop there. Taiwan reaches the factory as well — its manufacturing practice obligation extends to overseas sites, which makes the Korean manufacturer’s quality documentation part of market access rather than a courtesy. Ask for it early; it is slower to assemble than anything else on the list.
We document. Your local entity registers.
- Full quantitative formula and raw material specifications
- Manufacturing method description and quality system documentation for the site
- Stability, challenge and compatibility test reports
- Certificates of analysis by batch
- Sun protection filter identification and levels, with the test report behind any SPF figure
- Manufacturing documentation for the Product Information File
- The Taiwanese registration holder
- The product registration before supply
- The Product Information File held in Taiwan
- Chinese label copy and final artwork approval
- Claim review, so nothing on the pack reads as a medicinal effect
Manufacturing through contracted Korean partners, matched to your product — every order made in Korea. Certifications depend on the selected manufacturing partner and project requirements.
Why this market
Taiwan has one of the highest per-capita beauty spends in Asia and a dense pharmacy and drugstore channel, with buyers who compare Korean and Japanese products directly rather than treating Korean origin as a category of its own.
Traditional Chinese copy written for Taiwan carries part of the way into Hong Kong but not all of it — the two use different words often enough that the second market needs a pass rather than a copy. Plan them as two markets sharing a script.
Retiring the licensing tier lowered the step at the border without lowering the standard behind it: the file that used to be reviewed before a licence issued is now expected to exist from the first shipment onward. Brands that treat registration as the easy part and the file as paperwork are the ones who struggle when it is asked for.
Selling in Taiwan
Does Taiwan still require a separate licence for sunscreens and whitening products?
No. Taiwan used to run a two-tier system in which specific-purpose cosmetics — sunscreens, skin-lightening products and hair dyes among them — needed a licence before they could be sold. That tier was retired and the rules behind the licence were repealed. Every cosmetic now goes through the same product registration before supply. Guidance describing the old structure is still widely available online, which is the single most common reason Taiwan plans are built on the wrong timeline.
Can we sell a Korean sunscreen in Taiwan?
Yes, and it is more straightforward than it used to be. There is no separate licence to obtain. The filters are governed by a Taiwanese table that also accepts what the EU, the United States and Japan permit, used on those terms — wider than a closed national list, and wide enough for most Korean sun care. Check your filter system against it early anyway, and make sure the testing behind your SPF figure is in the file before the number goes on the pack.
Can we use our Simplified Chinese label in Taiwan?
No. Taiwan uses Traditional Chinese, and the difference is not only in the characters — the vocabulary for ingredients and for claims diverges from mainland usage. A converted file reads as written for somewhere else, which is the opposite of what the copy is meant to do. Have the Taiwan version written rather than converted. The full ingredient declaration is the one part that may stay in English.
Who holds the Taiwan filing — us or our distributor?
A business established in Taiwan. A Korean manufacturer cannot hold it. Since the registration is the market access, it and the distribution agreement are a single negotiation rather than two — the same trap as Vietnam and Indonesia. Settle what happens to the registration if the relationship ends, before the first shipment rather than after.
Sources
- Taiwan Food and Drug Administration — Ministry of Health and Welfare, Taiwan
- Ministry of Health and Welfare — Ministry of Health and Welfare, Taiwan
- Cosmetic Regulatory Framework in Korea — Ministry of Food and Drug Safety, Republic of Korea
Requirements differ by market and by product, and they keep changing. Cross-check the current position as your project moves, and confirm it with a qualified regulatory consultant in Taiwan before committing to a formula or a launch date. We review these pages against the sources above as the rules move.
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Tell us you are selling into Taiwan at the brief stage rather than after. It changes the formula, not just the label.
Start Your Project →This page is general information for manufacturing planning. It is not legal or regulatory advice, it has no legal effect, and no rights can be derived from it. Requirements change by market and over time — before acting on anything here, confirm the current position with the authority concerned or with qualified counsel.