Six questions decide your compliance route, and each one has a different right person to ask

Quality gets the product out. Culture gets the brand in. A skincare brand entering a new country settles its compliance route by answering six questions in a fixed order, because each answer narrows the next one. Terra Vista is a Japan-registered cross-border advisory group, and at this step our work is not to recite a statute book to you. Our work is to find which of the six your particular case turns on, and to name the party in that market who can actually answer it.

We do not act as a legal authority. We analyse each country’s situation on its own terms and give the judgement we consider the most reasonable and most workable for the case in front of us. Where an answer rests on a published document, we hand over the passage and the link so the answer can be checked rather than taken. Where no published document answers it, we say so instead of reasoning our way to a number.

Two markets carry the worked examples below, Japan and Thailand, because for both of them we keep a fact ledger, the source file in which every statement is tied to the document it came from, and where that document is a translation or a summary we say so on the spot. Vietnam sits on the candidate list for the same kind of brand, and not one Vietnamese rule appears on this page, because a rule we have not verified is more dangerous than a rule we admit is missing.

The six questions, and the party who can answer each one

Each row below pairs one question with the party able to answer that question, and with the input a brand must have settled before asking. Read the table as the running order of this step rather than as a checklist to tick, because the six only work in sequence.

Questions three and six are the two that brands most often answer by inference rather than by asking, and both are the kind of question where an inference costs far more than a phone call would. A wrong answer to question three runs into the criminal provisions of a statute; a wrong answer to question six quietly expires a permission that an entire supply chain is standing on.

Question one: the category a market assigns decides the filing route

Japan’s pharmaceuticals and medical devices Act defines a cosmetic by the purpose for which a product is used and by whether the action on the human body is mild, and that definition is where category attribution starts for anything sold as a cosmetic in Japan. Nothing in the definition ties category to the ingredient list, so the category can move when the intended purpose moves, even where the formulation has not changed by a single percentage point.

Quasi-drugs sit in a separate definition with three enumerated classes, and the third class covers only what the Minister has designated. A widely repeated shortcut says that any efficacy outside the 56-item cosmetic efficacy list turns a product into a quasi-drug. The quasi-drug definition does not say that, and the third class is not an automatic catch-all, because designation is required before anything falls into it.

Category then decides the route. Ordinary cosmetics need an advance notification per item; approval per item is required only for cosmetics containing ingredients the Minister has designated, and for quasi-drugs, under Articles 14 and 14-9. Formulation feeds back into this, because Japan’s cosmetics standard works as a prohibited list, plus maximum blend amounts, plus positive lists for preservatives and ultraviolet absorbers, as set out in the standard itself.

Thailand runs a different mechanism with a similar effect. Whoever intends to manufacture for sale, import for sale, or contract-manufacture cosmetics must notify the receiving officer, and may manufacture or import only once the notification receipt has been issued, under Section 14 of the Cosmetic Act. Calling that step a registration or an approval overstates it, because the section uses neither word.

Ask the regulator that will receive the filing, and bring the claim you intend to carry into the question rather than settling the claim first. Category follows from the intended claim, and whether that claim survives is settled when you write the claim, which is the step after this one and the subject of the page on writing a claim for a market.

Question two: who may hold the authorization, and whether an overseas company may hold it

Japan’s Act treats the sale of an imported cosmetic as manufacture and marketing, and permits only the holder of a cosmetics manufacture-and-marketing license to carry on that business. Selling into Japan through your own import is therefore the regulated act itself, not a step that sits outside the license, and the definition provision reaches it directly.

Two structural facts shape who can realistically hold that license. The license is granted by the prefectural governor, and jurisdiction is fixed by the location of the office where the general supervisor for quality management and post-marketing safety management performs those duties, under the cabinet order. That supervisor must satisfy one of four qualification routes set out in the enforcement regulation, which states nothing about residence, nationality, or full-time status.

Now the honest part. Whether a foreign corporation with no base in Japan can hold the license is a question our sources could not close. Of the Japanese provisions we searched — the license article of the Act, the cabinet order that fixes jurisdiction and the enforcement regulation article on the license application — none requires Japanese incorporation, and no primary source states the answer either way. Thailand lands in the same place, because Section 14 lists three actor types and says nothing about where the notifier must be established.

Whether you may hold the authorization yourself from outside the country is settled by that market’s regulator, and neither of the two statutes we hold answers it in express words. Put the question to the prefecture that would grant the license, and to a local party that has already stood as responsible party for a foreign brand, and do not read the answer out of the labelling rules.

Question three: operating under another company’s authorization is settled by statute, not by commercial convenience

Japan’s Act states that no person other than a holder of the relevant license may, as a business, carry on the manufacture and marketing of cosmetics, and a breach carries imprisonment of not more than three years or a fine of not more than 3,000,000 yen, or both, under Article 12 and Article 84. Legal prohibition, with a criminal penalty attached, is the whole answer to this question.

Look next at where the Act places the duties. The party named on the license is the party whose name and address go on the immediate container, the party carrying the compliance duties for quality management and post-marketing safety management, and the party the penalty provisions address, as our ledger records from Article 61(1), Article 84 and the surrounding provisions.

What the Act does not do is say, in either direction, whether a brand owner standing behind someone else’s license carries liability of its own, and neither position appears anywhere in the text we checked. Those named duties are therefore the reach of what the statute settles, and how much of your own exposure such an arrangement removes is not a question the wording answers.

Thailand reaches the same practical place by a different route. The notifier must be one of the three actor types, must manufacture or import in conformity with what was notified, and faces a fine of not more than 20,000 baht plus revocation of the receipt for non-conformity, under Sections 26, 36 and 71.

One caution matters more than the rest. Japan’s Act carries no clause built around the words name-lending, a finding our ledger records from a machine search across the full statutory text. Thailand’s half of the same finding rests on weaker evidence: the word search was run on an English translation of the Cosmetic Act rather than on the Thai original, laws outside that Act were not searched, and it therefore stands as not fully verified.

Absence of a clause with that name is not permission in either market. Japan’s prohibition bites on carrying on the manufacture-and-marketing business without holding the license, and Thailand’s requirement is that the notifier be one of the three actor types and that what is made or imported match what was notified, both as cited above.

Ask a different question instead: what does a lawful local responsible-party arrangement look like in this market? Put that to the regulator, for what the statute requires of that party, and to a local party that has stood as responsible party for a foreign brand before. No advisory arrangement, ours included, changes who the statute names, and we neither hold nor arrange authorizations in anyone else’s name.

Question four: the required documents have more than one owner, and the party that files is not the factory

Japan’s Act places the per-item notification duty on the manufacture-and-marketing license holder rather than on the factory, so the obligation does not move to a manufacturer however capable that manufacturer is, under Article 14-9. A separate rule requires the importing license holder to hold, by the time of customs clearance, a document evidencing that the notification for that item has been made, or a copy of one, under the enforcement regulation.

Compare the two markets on one document, the factory’s own accreditation, because the answers run opposite. Accreditation of a foreign manufacturer exporting to Japan is written as a route that may be taken rather than one that must be, in Article 13-3. Our ledger notes that the provision neither says export is impossible without accreditation nor says accreditation is unnecessary, so the working answer has to come from the regulator rather than from the wording.

A person importing cosmetics for sale in Thailand must import product made by a manufacturer accredited to one of seven listed standards or an equivalent not lower one, and must obtain a letter of authorization from the trademark owner or the manufacturer, under the 2018 ministry notification, which we hold in the regulator’s English text with the Thai original still to be read.

Record-keeping in Thailand attaches to the importer, not the factory. Customs entry documents and the list showing lot numbers must be kept for five years from the date of import, under the same notification, which also requires a certificate of analysis (COA) or equivalent conformance document to be kept for three years after the expiry date or five years after the manufacturing date, held in the product information file (PIF) together with a safety data sheet (SDS).

Sorting the list by owner rather than by document type is what turns a document list into a schedule, because each owner has a different lead time and a different reason to be slow. Our sources fix three of those assignments and no more, so treat the rest as an allocation to settle in your contracts rather than a rule to look up:

• Accreditation to a recognised manufacturing standard belongs to the manufacturer, because Thailand requires an imported product to have been made by a manufacturer accredited to one of seven listed standards or an equivalent not lower one, under the 2018 ministry notification, which we hold only in the regulator’s English text, so this threshold stands as not fully verified until the Thai original is read.
• A letter of authorization comes from the trademark owner or the manufacturer, and obtaining it is written as the importer’s duty in that same notification, held in the same English text and carrying the same caveat.
• Keeping the required information readily accessible to the authority at the address shown on the label is the duty of the company or person responsible for placing the product on the market, under Article 8 of the Association of Southeast Asian Nations (ASEAN) Cosmetic Directive.
• Who drafts the composition, the specifications and the manufacturing method is not settled by any source we hold, so settle those three in writing before the timeline is drawn rather than assuming the factory supplies them.

One myth is worth killing here, because it drives real cost. ASEAN Cosmetic Directive Article 8 requires the company or person responsible for placing a product on the market to keep composition, specifications, manufacturing method, safety assessment, adverse-effect data and supporting data for claimed benefits readily accessible at the label address, and the article sets no number of files at all.

No published rule sets how many files a portfolio needs. The Product Information File (PIF) guideline that introduced the word file into the conversation states on its own first page that it is not a legal document and that compliance with it is not a mandatory requirement, as the guideline says in terms. Content is mandatory under Article 8; arithmetic about dossier counts is not.

Question five: the label carries a different mandatory name in each market, and the language rules are not the same rule

Japan’s Act requires a cosmetic’s immediate container or immediate wrapper to carry seven categories of particulars, of which only the first three carry no condition in the text of the provision: the name and address of the manufacture-and-marketing license holder, the product name, and the manufacturing number or code, per Article 61. Items four to six apply only in designated cases, and item seven is narrowed by ordinance to a specific approval category.

Item four reaches further than that condition suggests. The designation behind item four, made by a ministerial notice in 2000, reads as the ingredients blended, per the notice, so in practice the ingredient list covers the whole formula, with the ingredients the Minister designates for an approval-route cosmetic taken out. The relocation rule set out below therefore decides more artwork than a conditional item would imply.

Whose name goes on the immediate container is what brands most often get backwards. Of the three particulars that carry no condition, the first is the name and address of the manufacture-and-marketing license holder, per Article 61. A factory’s name is not one of the seven particulars at all, and it replaces the license holder’s only on product supplied to another license holder or manufacturer for use in making other cosmetics and marked for manufacturing use only, per the enforcement regulation.

The ingredient listing, and only that item, may sit on outer packaging, an affixed tag or display card, or an accompanying document in defined small-container cases, under the labelling exception, which moves that one item rather than waiving it. Whether the first three items have any comparable room on the smallest bottle in the range is a question to put to the prefecture that will issue the license, not one to settle on the artwork.

One further exception reaches cosmetics only by cross-reference from the medicinal-product rules, where its terms cover ampoules of two millilitres or less among other narrow containers, per the enforcement regulation. No notice or administrative interpretation showing how that exception lands on a cosmetic is in our hands, so we do not read the first three items as absolute and we do not read the exception as available.

Thailand’s Act puts the label duty on the manufacturer for sale, the importer for sale, and the contract manufacturer, rather than on the seller. Labels must be truthful, must not mislead on material matters, must not offend Thai morality or good culture, and must use Thai text at a size that can be read clearly, with a foreign language permitted in addition, per Section 22.

Required content under the same section runs to the cosmetic name and trade name, the importer’s name and location together with the manufacturer’s name and country of manufacture for imported goods, quantity, directions for use, recommendations, warnings, month and year of manufacture and of expiry, the lot number or code, and the names of all substances used as ingredients.

Read that section with one warning attached. Imported cosmetics are exempt from a Thai label at the cosmetic checkpoint but must have one made before sale, and Section 22 itself delegates the operative detail to a committee notification, so the statute alone cannot be used to design a label.

The clock in that committee notification runs whether or not selling has started. Clause 4 of the Cosmetic Committee Notification on Cosmetic Labels B.E. 2562, published in the Government Gazette on 8 July 2019, requires the Thai label to be made within 30 days of the relevant officials releasing the goods at import, per the notification, which we read from the authority’s own copy of that file; its text layer drops characters, so the verbatim wording is still to be captured and the 30-day point stands as not fully verified. Hence “before sale” carries a date, and must not be read as “at your convenience”.

Two further warnings cut holes in what the section appears to require. Ingredient names may be written in Thai, in a Thai transliteration of English, or in English, under the 2019 committee notification on cosmetic labels, so the answer to which parts of a Thai label must carry the local language is not all of them.

Month and year of expiry is not a universal item either, because the same notification confines that duty to products with a shelf life of under 30 months, per that notification, and to the two categories listed in its annex, cosmetics containing hydrogen peroxide and sunscreen cosmetics containing avobenzone, per the annex to it. Both points are read from the authority’s own copy of that file, whose text layer drops characters, so the verbatim wording is still to be captured and both stand as not fully verified.

Question six: the expiry date and the renewal mechanics live in different documents from the one that grants the authorization

Japan’s cabinet order fixes the renewal period for a manufacture-and-marketing license at five years, while the Act itself only requires renewal at intervals of not less than three years to be fixed by cabinet order, per the order and the enabling provision. Reading only the Act gives you a floor and calls it a cycle; reading only the order hides the delegation that makes the number binding.

Prefectural guidance carries the operating detail. Tokyo’s guidance for license holders in that prefecture states a five-year validity and asks for the renewal application two to three months before the end of validity, on the metropolitan authority’s page for license holders. A standard processing period of 20 days, counted in open days excluding weekends, public holidays and the year-end period, is published on the same authority’s renewal-procedure page. It is stated there for renewals, and our ledger holds no published figure for a first application.

Thailand writes the number into the statute instead. A notification receipt is valid for three years from the date of issue, per Section 15. Renewal must be applied for before the expiry date, and the renewal fee must be paid together with that application; only once both have been done does the receipt stay usable until the receiver orders otherwise. A holder whose receipt has lapsed by not more than one month may apply for renewal and ask for a waiver by stating the reasons for missing the deadline, again paying the renewal fee with the application, and the waiver does not remove liability under Section 64.

Two numbers circulating online do not survive here, and they fail for different reasons. A fixed window of so many days before expiry is not in the Thai Act, which says only that renewal must be applied for before the expiry date, and we could not source that window in any published document, so we do not use it.

The second number is a fee. The schedule attached to the Act states a ceiling rather than a price, because Section 5 has the Minister set actual fees by ministerial regulation not exceeding the schedule, whose figure for an import notification receipt is 5,000 baht per copy, per Section 5 and the schedule.

Setting the actual rate is therefore done one level below the statute, and that ministerial regulation is not among the documents we hold. What an applicant pays is a question for the authority receiving the filing, not a number this page can quote off the schedule.

Staying alive is more than renewing, and change is the part that catches people. Changes to notified particulars in Japan must be notified within 30 days, per Article 14-9, and Thailand published ten subordinate instruments in one batch on 24 December 2025, adding 17 prohibited substances in two tranches effective 25 December 2025 and 22 June 2026, per the authority’s own clarification.

Two further duties sit on the license holder rather than on anyone else, and we mark both as summarised from prefectural guidance rather than read off the statute: a voluntary recall must be reported to the governor once it starts, and adverse events must be reported to the Minister within 15 or 30 days depending on the case, on the same guidance page. Read both as confirming who carries the file, because whoever holds the license carries these as well.

What we settle at this step, and what we do not do

We take one case through the six questions in order, using the product form, the formulation type, the claim you want to carry, and the pack. Then we tell you which of your current answers does not hold, and what we consider the most workable route from there. Where an answer rests on a document, we hand over the passage; where it rests on practice, we say whose practice and how to test it.

Verification is the unglamorous half of this step, and it is not optional. An English translation published on a market regulator’s own site understated one fine by a factor of ten, showing 30,000 baht where the Thai original says 300,000 baht, as recorded against that translation. Working from a convenience translation is how a brand ends up confidently wrong about the size of its own exposure.

Boundaries belong in writing too. We do not prepare or submit filings on anyone’s behalf, we do not stand as anyone’s responsible party, and we do not hold or arrange authorizations in another company’s name. What we do is decide which questions your case actually turns on, name the party who can answer each, and rewrite the question so that party can answer it directly.

What our sources do not answer, and why we print that

Five gaps sat in the way of this page, and naming them here is more useful than filling them with reasoning that would read just as smoothly as a sourced answer. Each of the five is a question that a regulator or a locally qualified lawyer can close in a single exchange, which is exactly why guessing at them is the expensive option:

• Whether an overseas company with no local base may hold the Japanese license, or be the Thai notifier: the three Japanese provisions we searched — the license article of the Act, the cabinet order that fixes jurisdiction and the enforcement regulation article on the license application — say nothing either way, and Thailand’s Section 14 lists three actor types without saying where the notifier must be established. No primary source we hold states the answer.
• Thailand’s actual fee amounts sit in a ministerial regulation we have not read, so only the statutory ceiling is quotable.
• The Thai committee notification that carries the operative labelling detail has not been captured in clean verbatim form, so specific label mechanics stay marked as not fully verified.
• Japan’s processing time for a first license application has no primary source in our ledger, and the published renewal figure answers a different question.
• Whether any Thai law outside the Cosmetic Act touches name-lending has not been searched, and the search inside that Act was run on an English translation rather than on the Thai original, so that finding stands as not fully verified.

Printing a gap is cheaper than printing a guess. A brand that knows which two questions are still open can spend one call closing them, whereas a brand handed six confident answers has no way to tell which of the six will not survive its first exchange with the regulator.

Questions brands ask at this step

Does an overseas company have to set up a local entity to be the responsible party?

Neither statute in our ledger answers that in express words. Of the Japanese provisions we searched — the license article of the Act, the cabinet order that fixes jurisdiction and the enforcement regulation article on the license application — none requires Japanese incorporation, and no primary source states the answer either way; Thailand’s Section 14 lists three actor types without stating where the notifier must be established. Put the question to the regulator that would grant or receive the filing.

May a brand use another company’s license or notification receipt to reach the market?

Japan’s Act permits only a license holder to carry on manufacture and marketing as a business, with imprisonment of not more than three years or a fine of not more than 3,000,000 yen, or both. Thailand’s Cosmetic Act requires the notifier to be one of three actor types and to manufacture or import in conformity with the notification. Japan’s Act carries no clause built around the words name-lending on a machine search of its full text; for Thailand the same search covered an English translation of the Cosmetic Act only, so that half is not fully verified. Absence of such a clause is not permission.

How many product information files does a ten-product range need?

No published rule sets a number. ASEAN Cosmetic Directive Article 8 defines what information must be readily accessible at the label address, and the Product Information File (PIF) guideline states that it is not a legal document and that compliance is not mandatory. Content is the obligation; file count is not.

How long does the authorization last in each market?

Japan fixes five years for a manufacture-and-marketing license by cabinet order, while the Act sets only a floor of not less than three years. Thailand writes three years from the date of issue into the Act itself. Diary the expiry on the day the authorization is granted, and diary the renewal window ahead of it.

Where this step sits

The break in cross-border business is not logistics — it is culture. Goods ship, money transfers, and regulations can be checked line by line, exactly as this page has just done. What does not travel is the business context, the decision logic, and the way trust gets built in a place where the deciding is done differently. So the way we work is: Culture as the bridge, understanding as the path.

Across these six questions that means Culture Isn’t Cargo — understand culture, don’t just ship it. In practice, that is not carrying over the compliance habits that worked at home and assuming the same parties answer the same questions, but working out first who decides what in this market, and only then settling what gets filed, what gets printed, and what gets said. Terra Vista is a Japan-registered cross-border advisory group, and every answer above is handed over with the document it rests on.

The running order for the whole route is fixed. Choose the market, then work out that market’s rules, then write the claim, and choose the factory last. This page is the second of those four, and each of the other three changes the answers to the six questions above, which is why the order is not a matter of preference.

Each of the others owns one segment: the regulator rules on the filing, the local responsible party carries the license, the factory makes what it can make, and the agency writes the copy. What we own is the brand not changing shape as it moves between them. All four steps, and the reasoning behind that order, sit on our four-step page.