Todokede for Class I General Medical Devices: Notification Without Technical Review

1. Key takeaways

The todokede (notification) route for general medical devices is an administrative filing with no technical review, yet none of its preconditions is waived: a Japanese manufacturing and sales (marketing authorization holder) licence must already be held, and the overseas manufacturing site must already be registered as a foreign manufacturer. In its Japan projects GRZAN has repeatedly seen Chinese manufacturers treat Class I as a category they can ignore, and then fail in two places: post-market vigilance and change management. A route without review is not a route without regulation.

• The notification obligation sits in Article 23-2-12 of the PMD Act: any person intending to manufacture and sell general medical devices must file a notification with PMDA.
• The definition of general medical devices and the Minister of Health, Labour and Welfare’s designation power are in Article 2(5) of the PMD Act.
• The MAH licence is the third-category licence under Article 23-2(1); the licence is issued by prefectural governors, not by PMDA.
• Foreign manufacturer registration is required under Article 23-2-4(1), with a five-year validity period under paragraph (2).
• Malfunction reporting under Article 68-10(1) binds the marketing authorization holder and applies equally to notified items.
• GRZAN’s assessment: the two failure points in Class I projects are building the GVP system too late and selling silently after a change in notified content. Both are cheap to prevent and expensive to remediate.

2. Legal basis

Notification obligation. Under Article 23-2-12 of the PMD Act, a person who intends to engage in the manufacturing and sale of general medical devices must submit a notification to PMDA. No conformity assessment, review or judgment of quality, efficacy or safety precedes acceptance; the filing records the item, the holder and the manufacturing site.

Definition and designation. Article 2(5) of the PMD Act defines general medical devices and vests the designation power in the Minister of Health, Labour and Welfare. Items are general devices because the Minister has so designated them, not because the applicant chooses the label.

Holder licence. Article 23-2(1) requires the manufacturing and sales business licence (the third category). This licence is issued by prefectural governors and is a precondition, not a parallel formality.

Foreign manufacturer registration. Article 23-2-4(1) requires overseas manufacturing sites to complete foreign manufacturer registration; under paragraph (2) the registration is valid for five years and must be renewed. The scope of registered processes is defined by item category in Article 114-8 of the Order for Enforcement.

Post-market obligations. Article 68-10(1) imposes the malfunction reporting duty on the marketing authorization holder. The duty applies to notified items in the same way as to approved items, which is why a GVP system, record retention and a reporting workflow are required from the first shipment.

Current legal corpus. Act No. 145 of 1960 (the PMD Act), as comprehensively amended by Act No. 84 of 2013, promulgated on 27 November 2013 and effective on 25 November 2014.

Practical estimate: acceptance of a notification commonly completes within one to four weeks, excluding the upstream preparation of the licence and registration; the period varies with the completeness of the filing.

3. Expert insights

The notification is filed with PMDA, but the licence sits with the prefecture. The Article 23-2-12 notification is submitted to PMDA, while the manufacturing and sales licence under Article 23-2(1) is issued by the prefectural governor. The two tracks run in parallel and neither screens for the other as a precondition, so the sequencing duty falls entirely on the applicant: licence first, notification second. If the order is reversed, the notification fails because the applicant lacks qualification. GRZAN recommends building a written sequence plan with both receiving bodies identified and their independent processing periods scheduled separately.

Class I does not waive foreign manufacturer registration. Japan’s registration requirement for overseas manufacturing sites does not disappear at low risk levels. Article 114-8 of the Order for Enforcement defines the registered processes by item category. For general medical devices the design stage is not a registered process, but primary assembly, sterilization and similar processes may still fall within scope. The correct method is to walk the site’s process map against the article, item by item, rather than to assume that low risk means no registration. A site shipping to Japan without registration where a registered process is performed creates an enforcement exposure that no notification can cure.

Post-market duties are independent of the pathway. Article 68-10(1) places the malfunction reporting obligation on the marketing authorization holder, and notified items are covered in the same manner as approved items. A notified Class I product still requires a GVP system, retained records and executed reporting. GRZAN lists this as the most common post-launch gap in Class I projects: teams that invested nothing in review preparation also invest nothing in vigilance, and discover the gap at the first reportable event or inspection.

4. Practical recommendations

• Sequence the project as licence, then registration, then notification. The three steps have different receiving bodies and independent processing periods (practical estimate: one to four weeks for notification acceptance, excluding upstream preparation).
• Build the GVP system before the first shipment. Record retention, malfunction judgment criteria and the reporting workflow should all be in place and rehearsed, not merely documented.
• Confirm the foreign manufacturer registration scope process by process against Article 114-8 of the Order for Enforcement. Never infer from the Class I label that no registration is needed.
• Update the notification whenever its content changes. Any change to item information, the manufacturing site or the licence holder must be handled through the prescribed procedure; silent selling after a change is a compliance breach.
• Assign a named owner for each precondition so that licence, registration and notification do not drift onto separate timelines.

5. Verification checklist

• □ Has the manufacturing and sales licence (third category) been obtained before the notification is filed?
• □ Has every relevant overseas manufacturing site completed foreign manufacturer registration, and is the five-year validity period current?
• □ Has the registered-process scope been confirmed process by process against Article 114-8 of the Order for Enforcement?
• □ Are the GVP system and malfunction reporting workflow established before first shipment?
• □ Is there a defined update procedure and a named owner for changes to notified content?

Regulatory information verified as at 29 October 2026. Legal texts follow the current provisions published on e-Gov and the notices issued by MHLW and PMDA, and must be rechecked after amendment or repeal. Time limits and procedural details reflect the official position on that date; content marked practical estimate has no legal effect.

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 manages PMDA premarket submissions and notification procedures, coordinates clinical evidence, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com