Selling or leasing highly controlled medical devices in Japan: premises and the office manager

In short: to sell or lease contact lenses and other highly controlled medical devices, you need a permit from the prefectural governor for each business office (Article 39(1) of the Pharmaceuticals and Medical Devices Act). The permit requires premises that meet the standards and a qualified business-office manager. Controlled medical devices such as hearing aids need only a notification.

Updated and sources checked: 12 October 2026. This article organises premises and manager checks when choosing a store. Tokyo’s permit guidance was retrieved, but current consolidated statutes, final amendment numbers and complete commencement histories for the Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, etc. (医薬品、医療機器等の品質、有効性及び安全性の確保等に関する法律), its regulations and the premises regulation were not obtained or reconciled and remain unverified. The authority and qualified professionals assess individual permit compliance.

What permit is needed to sell or lease highly controlled medical devices?

Article 39(1) provides that anyone who sells, delivers or leases highly controlled medical devices (including specially controlled maintenance devices) as a business must obtain a permit for each business office. Under Article 39(2), the permit is granted by the prefectural governor for the office's location (in cities and special wards with a public health centre, the mayor or ward head is the point of contact).

Medical devices are classified by risk, and the procedure differs by the class handled.

Category	Approximate class	Example	Sale/lease procedure	Basis
Highly controlled medical device	Class III/IV	Contact lenses	Permit	Article 39
Controlled medical device	Class II	Hearing aids	Notification	Article 39-3
General medical device	Class I	Steel instruments	Generally none	—

Non-corrective colour contact lenses are also treated as highly controlled medical devices. Under Article 39(6), the permit must be renewed every six years or it lapses. Confirm which class your products fall into with the prefectural pharmaceutical-affairs section before applying.

Who can serve as the business-office manager? (qualifications and training)

The manager qualification depends on the products handled. Tokyo’s permit guidance, retrieved on 12 October 2026, describes a basic course after at least three years in sales-related work for general highly controlled devices, and at least one year plus the corresponding basic course where only the specified contact lenses are handled. A separate category applies to software-only devices. Confirm products, experience and course certificates, including any equivalent physician or pharmacist qualification, with the receiving authority. The current consolidated text and amendment history of Regulation Article 162 were not obtained and remain unverified.

Article 168 of the enforcement regulation further requires the seller or lessor to have the office manager take annual continuing training run by a party that has notified the Minister. Securing the manager's experience and course records, and planning the yearly training, from the hiring and placement stage makes the application smoother.

Item to confirm	Reason
Sales-related experience (generally at least 3 years; at least 1 year for specified contact lenses only, etc.)	Whether the Article 162 standard is met
Basic-course completion certificate	Proof of the qualification
Schedule for yearly continuing training	The Article 168 training obligation

Qualification categories differ by the products handled (highly controlled, specially controlled, etc.). Confirm the current standards and eligible courses in the prefectural review criteria.

What is required of the premises and storage?

One permit standard is the premises. The Article 39 permit standard provides that a permit may be withheld where the office's premises do not meet the ordinance standard (Article 4 of the Regulation on Structure and Equipment of Pharmacies, etc.). In general, the premises must store devices hygienically and safely and keep them separate from other goods. For a leased property, the key points are area, partitioning and storage space, and whether you can prepare the site location sketch and floor plan to attach to the application.

Detailed numeric standards and attachment forms differ by municipality. At the viewing stage, confirm that you can secure a storage area and that the use does not conflict with zoning or building rules, and do preliminary checks at the pharmaceutical-affairs desk before signing. We assist with property selection and preliminary viewing checks, but the final judgement on whether the premises meet the standard is made by the authority receiving the application.

How does notification for controlled medical devices differ?

The sale or lease of controlled medical devices (excluding specially controlled maintenance devices) requires only a notification to the prefectural governor for the office's location, under Article 39-3(1). Rather than a prior review like a permit, it is a procedure of notifying the prescribed items. Hearing aids are a cited example. General medical devices (Class I) generally require no special procedure for sale or lease.

That said, even for controlled medical devices, other obligations may apply by category, such as appointing an office manager (e.g. a manager for specially controlled devices) or a best-effort duty for continuing training. "Notification means nothing else is needed" is not correct. Correctly determining the category of the products handled is the starting point.

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How long does the permit take, and what does it cost?

The permit application fee is set by prefectural ordinance and regulation, and the amount differs by municipality. The standard processing period for the review is also shown in each municipality's review criteria. In general the process includes preparing the application documents, the office floor plan, confirming the manager's qualification and an on-site check; deficient documents lengthen it.

Confirm the exact fee, standard processing period and list of required documents in the latest guidance of the prefecture (or public-health-centre city or special ward) with jurisdiction over the office, before applying. This article does not give fixed amounts or days (the variation between municipalities is large, and we have not verified them here, so they are treated as unverified).

How are documents, premises, employment and medical judgement handled separately?

Who to engage	Scope
四葉行政書士事務所	Preparing permit and notification documents (assisting the applicant's own filing)
四葉不動産株式会社	Selecting the store property; preliminary checks on zoning and building rules; viewing brokerage
Labour and social security attorney	Employment, work rules and social-insurance design for staff
Doctors, pharmacists and other qualified persons	Judgements on device conformity or medical practice

四葉行政書士事務所, 四葉社会保険労務士事務所 and 四葉不動産株式会社 are each a separate, independent business. You contract with each field's provider separately as an independent business, and each provider bills and receives payment directly. Our office receives no referral fee. The prefectural pharmaceutical-affairs section is the administrative point of contact for permits and notifications, not a party engaged under a professional-services contract.

See permits and licensing support, the engagement process and the fee schedule. For similar store permits, the pharmacy permit: premises and managing pharmacist and the clinic opening notification are useful references.

FAQ

Q. Do I need a permit if I only sell contact lenses?
A. Yes. Both corrective and non-corrective colour contact lenses are highly controlled medical devices, and selling or leasing them as a business needs an Article 39(1) permit for each business office.

Q. Must I hire a business-office manager from outside?
A. The manager qualification depends on the products handled. Tokyo’s permit guidance, retrieved on 12 October 2026, describes a basic course after at least three years in sales-related work for general highly controlled devices, and at least one year plus the corresponding basic course where only the specified contact lenses are handled. A separate category applies to software-only devices. Confirm products, experience and course certificates, including any equivalent physician or pharmacist qualification, with the receiving authority. The current consolidated text and amendment history of Regulation Article 162 were not obtained and remain unverified.

Q. If I only sell online, do I still need premises?
A. You need a business office that serves as the sale or lease base, and you obtain the permit for that office. Controlled medical devices, excluding specially controlled maintenance devices, require a notification. Mail-order display rules also apply, so confirm with the receiving authority.

Q. How long does the permit take to be granted?
A. The standard processing period is set in the municipality's review criteria, and the amount also varies by municipality. It depends on whether the documents and premises are ready. This article does not give fixed days or costs.

Sources (Primary Information)

• e-Gov: Pharmaceuticals and Medical Devices Act: Article 39(1) and (2) (permit and prefectural governor), Article 39(6) (six-yearly renewal), Article 39-2(1) (business-office manager), Article 39-3(1) (controlled-device notification).
• e-Gov: enforcement regulation: Article 162 (product-specific manager criteria), Article 168 (continuing training). Current consolidated text and commencement history were not obtained (unverified).
• Tokyo Bureau of Public Health: risk classification and the permit/notification for sale and lease: the classification and the distinction of procedures (referenced 2026-10-12).
• Article 4 of the Regulation on Structure and Equipment of Pharmacies, etc. (premises standard). Confirm fees, standard processing period and attachment forms in the latest guidance of the prefecture (or public-health-centre city or special ward) receiving the application.

Updated and retrieved 2026-10-12. Product-specific manager qualifications are limited to the Tokyo text actually obtained. e-Gov consolidated provisions have not been treated as retrieved. Statutes, amendment and commencement histories, receiving-authority premises assessments, fees and standard processing periods remain unverified; publication is held pending qualified review.

This is general information and does not guarantee the grant of an individual permit, a manager's eligibility, premises conformity, or processing time or cost. Judgements on device conformity or medical practice are made by qualified professionals such as doctors and pharmacists, and the final decision on a permit or notification is made by the competent authority. Written by Joji Uramatsu, administrative scrivener and licensed real-estate transaction specialist.