Most brands that write to a Japanese factory for the first time have a concept, not a specification — an ingredient in mind, a market in mind, maybe a bottle they like the look of. That is a normal starting point, but a concept cannot be quoted or manufactured. It has to pass through a sequence of checks and decisions before a factory can put a price on it.
This guide sets out that sequence in order: concept and market, the regulatory check in your own market, the formula check against Japanese food law, dosage form, samples, specification, production, documents and shipping, and launch. Each step narrows the decisions the next one depends on, so working through them in order avoids the most common cause of delay — discovering late that an early choice does not survive a later check.
💬 Working from a concept rather than a finished specification? That is the normal starting point. See Japan-made supplement OEM for how we take a concept through to a manufacturable formula.
1. Concept and market
Decide what the product is for and where it will be sold before anything else, because the destination market decides which documents and label rules apply later.
A concept is the ingredient or combination you want to build around, the audience, and the country or countries you intend to sell in. The market matters early because it decides what “compliant” means for the rest of the project: a product aimed at the EU answers to EU novel food and health claim rules; a product aimed at the US answers to FDA dietary supplement rules; a product aimed at an ASEAN market answers to that country’s supplement or health-food registration route. None of those are Japanese rules, and Japan being the manufacturing country does not exempt the product from them.
| Decision at this stage | Why it matters later |
|---|---|
| Target country or countries | Sets label language, claim rules, and which documents (Certificate of Free Sale, certificate of origin) your importer will ask for |
| Target consumer and positioning | Shapes dosage form and flavour/format choices |
| Rough budget for first order | Narrows dosage form and packaging options realistically |
2. Regulatory check in your own market
Check whether your ingredients, claims and label are legal in your own market before committing to a Japanese formula, because Japan’s rules are not your market’s rules.
A formula that is perfectly legal as a Japanese food can still fail in your own market — an ingredient might need pre-market notification, a claim might need substantiation you do not have, or a maximum dose might be lower at home than in Japan. This check sits with you or your regulatory adviser, because Sunsho Trade cannot practise another country’s law. What we can do is tell you plainly what the Japanese side of the product will look like — its ingredient list, its dosage form, its documents — early enough for your own check to run in parallel rather than after the fact.
3. Formula check against Japanese food law
Every ingredient is checked against Japan’s list of substances treated exclusively as medicines before a factory will discuss dosage form or price.
Japan’s Ministry of Health, Labour and Welfare maintains a list of substances treated exclusively as medicines, attached to its notice of 31 March 2020 (薬生監麻発0331第9号), building on the principles of Notice No. 476 of 1 June 1971. A product containing one of those substances cannot legally be made as a food in Japan, whatever the label says, and no Japanese food factory will manufacture it. Some ingredients that are ordinary supplements elsewhere — certain doses or extracts of melatonin and ashwagandha among them — sit on or near this boundary in Japan, so it is worth checking each ingredient in a formula individually rather than assuming the category is fine because one product using it exists abroad.
This check also decides whether the finished product could be notified in Japan itself as a Food with Function Claims or a Food with Nutrient Function Claims, which is a separate question from whether it can be exported — a Japan-made product for export only does not need a Japanese notification, but the same food-versus-medicine boundary still applies to what a factory is allowed to manufacture.
💬 Send us your ingredient list first. We check it against Japanese food law before any conversation about dosage form or cost. Send your formula.
4. Dosage form
The dosage form is chosen from the ingredients’ own stability and dose, not from marketing preference, and it is decided before the specification is written.
Tablet, hard capsule, softgel, powder, granule, jelly, drink and gummy each carry different dose capacities and cope differently with heat, moisture and taste. An ingredient dosed in grams — collagen peptide, for example — will not fit a swallowable capsule at an effective dose; an oil-soluble carotenoid such as astaxanthin usually needs a softgel to carry it. Our dosage form guide compares all seven forms against dose capacity, stability and cost driver, and our ingredient guides (for example collagen peptide and astaxanthin) note the form each ingredient is usually formulated in.
Capsule shell, tablet coating, excipient and colourant choices follow from the dosage form. See our guides on hard capsule shells, softgel shells, tablet coating and excipients for the detail behind each.
5. Samples
A sample is made against a written formula so both sides are judging the same thing, and it is normal to ask for more than one round.
Once the ingredients and dosage form are fixed, the factory produces a sample — taste, texture, appearance and, for some products, a stability check. It is common to go through more than one round of samples before a formula is settled, particularly for taste-sensitive forms such as gummies, jellies and drinks. See our dedicated guide on samples and quotations for how this stage usually runs.
6. Specification
The product specification — ingredients and amounts, dosage form, weight, appearance, microbiological and heavy-metal limits, shelf life, storage and packaging — is what turns a sample into something a factory can quote and manufacture repeatedly.
Once a sample is approved, it is written up as a formal specification. This is the document every later step refers back to: the quotation is priced against it, the certificate of analysis is tested against it, and any dispute about whether a batch is correct is settled by it. See our dedicated guide on what a specification sheet contains.
7. Production
Production takes place at a GMP-certified partner factory in Japan, and for some product categories GMP is now a legal requirement rather than a voluntary standard.
From 1 September 2026, Japan’s Consumer Affairs Agency made GMP-based manufacturing control a legal requirement for Foods with Function Claims sold in tablet, capsule, powder and liquid form, with the manufacturer subject to CAA on-site inspection; whether gummy and jelly forms are covered is not spelled out, and a proposal still under discussion would leave them out of mandatory GMP at first. Your product does not need to be a Japanese notification to be manufactured at a GMP-certified line, and Sunsho’s production takes place at a GMP-certified partner factory in Japan as standard.
8. Documents
A batch of finished product comes with a certificate of analysis and the specification it was made against; export documents are prepared separately once shipping is arranged.
The certificate of analysis (CoA) shows what the factory or a testing laboratory actually measured against the specification’s limits for that batch — see our CoA guide for what it typically contains. If your market asks for a Certificate of Free Sale, since 1 April 2020 these have been issued by the regional agricultural administration offices of Japan’s Ministry of Agriculture, Forestry and Fisheries (see our Certificate of Free Sale guide), for food products manufactured in Japan that are or could be sold in Japan; the certificate does not certify the safety of an individual exported product.
| Document | What it shows | Who issues it |
|---|---|---|
| Specification | Ingredients, amounts, dosage form, weight, appearance, limits and shelf life | Agreed between brand and factory |
| Certificate of analysis (CoA) | Test results for the production batch against the specification | The factory or a testing laboratory |
| Certificate of Free Sale | Made in Japan and freely saleable in Japan as a food | Regional agricultural administration office (MAFF) |
| Certificate of origin | Country of origin, for customs and any preferential tariff | The competent issuing body in Japan |
9. Shipping
Commercial shipping documents and a certificate of origin are arranged around the production schedule, once the specification and quantity are fixed.
A certificate of origin supports customs clearance and any preferential tariff treatment your market offers for goods made in Japan. Packaging and labelling for export — including any market-specific label requirements — should be confirmed before production, not after, since relabelling a finished batch is far more limited than deciding the label before printing. See our export labelling guide for the general principles.
10. Launch
Launch is a market-side step — your own regulatory notification or registration, your own label, your own marketing — built on documents a Japanese factory has already prepared.
By this stage you hold a specification, a certificate of analysis for the batch, and, where relevant, a Certificate of Free Sale and certificate of origin. What remains is specific to your own market: registering or notifying the product where your country requires it, finalising local labelling, and bringing the product to your own customers.
Before you ask for a quotation
A factory can quote accurately once the concept has passed through the formula check and the specification is fixed.
- The ingredients and target market you have in mind
- Whether you have already checked the formula against your own market’s rules
- Your preferred dosage form, and why
- Whether you already have a specification, or need one built from a sample
- The documents your market typically asks an importer to provide
- Countries you plan to sell in
💬 Ready to start? Send us your concept and we will tell you which of these steps come first for your product.
Frequently asked questions
1. Do I need a finished specification before contacting a Japanese factory?
No. Most brands start with a concept — an ingredient, an audience, a market — and the specification is built during the sample stage. Starting the formula check early saves time later.
2. How long does the process from concept to launch usually take?
It depends on the dosage form, how many sample rounds are needed, and your own market’s registration timeline, so we do not publish a general figure. Ask about your specific product and we will explain the sequence involved.
3. Can I skip the formula check if my ingredient is a common supplement in my own country?
No. Japan’s food–medicine boundary is decided by Japanese rules, not by what is sold elsewhere, so an ingredient that is an ordinary supplement in your market can still fail the Japanese check. We run this check first for exactly that reason.
4. Who handles registration or notification in my own market?
You or your regulatory adviser, in almost every market. A Japanese factory can supply the specification, certificate of analysis and, where applicable, Certificate of Free Sale and certificate of origin that a local registration usually asks for, but it does not carry out the registration itself.
5. Does starting with a small first order limit which dosage forms are available?
It can. Some dosage forms need dedicated tooling or a minimum production run to be efficient, which affects which forms suit a first order. This is worth raising early rather than after a specification is fixed.
Sources: Ministry of Health, Labour and Welfare, notice 薬生監麻発0331第9号 (31 March 2020) on substances treated exclusively as medicines, building on Notice No. 476 (1 June 1971); Consumer Affairs Agency, “「錠剤、カプセル剤等食品の製造管理及び品質管理(GMP)に関する指針(ガイドライン)」に係る項目解説及び自己点検表について” (caa.go.jp/notice/entry/042170/), published 2 May 2025, confirming the 1 September 2026 mandatory GMP date for Foods with Function Claims in tablet, capsule, powder and liquid form; Ministry of Health, Labour and Welfare procedural guidance on Certificate of Free Sale issuance by the Food Sanitation Division of the competent Regional Bureau of Health and Welfare. Checked on 25 September 2026.