Package Insert and Labeling Requirements under Articles 63 and 63-2

1. Key takeaways

Japan’s labeling requirements for medical devices are split across two provisions: Article 63 governs the entries on the immediate container or immediate packaging (8 items in total), and Article 63-2 governs the entries in the package insert or on containers and packaging (5 items in total). These are parallel obligations, not alternatives. Preparing an excellent package insert while ignoring the container markings is a common finding in Japanese market inspections — the two sets of entries must both be complete, and neither substitutes for the other.

• Article 63 lists 8 entry items for the immediate container or immediate packaging, covering the marketing authorization holder, the device name, manufacturing identifiers, content volume, standards-based entries, expiry period, and ordinance-specified matters.
• Article 63-2 lists 5 entry items for the package insert and related documents, covering directions for use and precautions, maintenance and inspection matters, standards-based entries, and ordinance-specified matters.
• Both provisions contain carryover clauses referencing the standards under Article 41, Paragraph 3 and Article 42, Paragraph 2, so the applicable standards can dictate labeling content directly.
• Specially controlled maintenance-required medical devices carry additional entry requirements on the device body under Article 63, Paragraph 2.
• Article 64 applies Articles 53 through 55 mutatis mutandis, bringing the prohibition of false and exaggerated entries into labeling and inserts.

2. Legal basis

The labeling obligations form a two-track system in the PMD Act — container entries and package insert entries — reinforced by the mutatis mutandis application of the advertising provisions and by the electronic delivery option in the Implementing Rules.

• PMD Act Article 63: entries on the immediate container or immediate packaging of medical devices, 8 items in total — including the name or trade name and address of the marketing authorization holder, the name of the device, the manufacturing number or manufacturing symbol, the content volume for designated products, matters required under the Article 41, Paragraph 3 standards, matters required under the Article 42, Paragraph 2 standards, the expiry period for designated products, and matters specified by MHLW ordinance.
• PMD Act Article 63-2: entries in the package insert and related documents, 5 items in total — including directions for use and other necessary precautions for use and handling, maintenance and inspection matters for designated products, matters required under the Article 41, Paragraph 3 standards, matters required under the Article 42, Paragraph 2 standards, and matters specified by MHLW ordinance.
• PMD Act Article 63, Paragraph 2: special entry requirements for specially controlled maintenance-required medical devices (the matters of items 1 through 3 and item 8).
• PMD Act Article 64: the mutatis mutandis application of Articles 53 through 55 (including the prohibition of false or exaggerated entries).
• Implementing Rules, Article 225: provision of the package insert by electromagnetic means.
• Current statute: Act No. 145 of 1960.

3. Expert insights

Insight 1: Article 63 and Article 63-2 each carry their own standards carryover clauses.

Both provisions include items requiring the entries specified under the Article 41, Paragraph 3 standards and the Article 42, Paragraph 2 standards. This means the certification standards or the Essential Principles themselves can directly prescribe labeling content. When drafting the labeling and the package insert, companies must therefore read the applicable standards first to extract their entry requirements, and only then complete the statutory items. Drafting in the opposite order — filling in the statutory items and treating the standards as an afterthought — risks discovering late in the process that a standard requires information the label was never designed to carry, forcing layout changes at the worst possible time.

Insight 2: Specially controlled maintenance-required medical devices have additional body marking requirements.

Article 63, Paragraph 2 targets specially controlled maintenance-required medical devices and requires the matters of items 1 through 3 and item 8 to be entered on the device body. These products are largely high-risk devices that require periodic maintenance, and the marking requirement extends to the device body itself rather than stopping at the packaging. Companies whose products fall into this category must plan how the required entries will be physically present on the device — durably, legibly, and consistent with the product design. Determining whether the classification applies, and designing the body marking early, prevents late-stage redesigns and ensures the inspection finding is never the missing body label.

Insight 3: The mutatis mutandis application of Article 64 pulls the advertising rules into labeling.

Article 64 applies Articles 53 through 55 mutatis mutandis, which involve the prohibition of false and exaggerated entries. The wording of the package insert and the labeling is therefore subject to the advertising regulations at the same time, and promotional phrasing carries legal risk in this context. Claims that would be permissible in a marketing brochure may be impermissible in an insert, because the insert is a regulated document rather than promotional material. Reviewing insert and labeling language together with the advertising rules — before printing, not after — keeps the regulated texts within the boundary the statute draws.

4. Practical recommendations

• Build a labeling checklist following the 8 items plus 5 items. Check the container markings and the package insert separately; neither replaces the other.
• Read the standards before writing the documents. Extract the entry requirements from the applicable certification standards or Essential Principles, then complete the statutory items.
• Prepare body marking for specially controlled maintenance-required devices. Confirm whether the product falls into this category and plan the body marking method early.
• Avoid promotional wording. Because of the mutatis mutandis application of Article 64, review the wording of inserts and labeling together with the advertising regulations.

5. Verification checklist

• □ Have the entries on the immediate container or packaging been checked item by item against the 8 items of Article 63?
• □ Has the package insert been checked item by item against the 5 items of Article 63-2?
• □ Have the entry requirements been extracted from the applicable standards (Article 41, Paragraph 3 / Article 42, Paragraph 2)?
• □ For specially controlled maintenance-required devices, has the body marking been prepared under Article 63, Paragraph 2?
• □ Have the wording of the insert and the labeling been reviewed against the advertising regulations under the mutatis mutandis application of Article 64?

Legal information verified as of October 29, 2026.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, in-country representative and local testing support for the Japanese market. Our team prepares J-GCP/J-QMS compliant dossiers, coordinates conformity assessments, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com