Regulatory Affairs Consulting Services in Japan

Optimised regulatory affairs strategies in Japan for smooth product registration and approval across various healthcare industries. Artixio, a trusted Japan regulatory affairs solution firm, helps you manage local requirements with clarity and confidence.

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Regulatory Affairs in Japan

Japan’s regulatory system designed to support new technologies while meeting it’s regulatory authority requirements. Companies entering the Japanese market, need to manage local regulations, prepare documents in Japanese, and follow specific submission processes. Pharmaceuticals and Medical Devices Agency (PMDA) and the Ministry of Health, Labour and Welfare (MHLW) are the regulatory authorities in Japan responsible for overseeing product development, regulatory affairs, registration, and post-market requirements. Artixio provides expert consulting services for regulatory affairs in Japan to guide you through each step of the process.

We aim to make the approval process clear and efficient, helping your products reach the market confidently. With our expertise, you’ll receive guidance throughout the process, giving you the support you need to succeed in Japan. We at Artixio, aim to make the approval process clear and effective, helping your products reach the market confidently. With our top regulatory affairs support in Japan, you’ll receive expert guidance throughout the process, giving you the support you need to succeed in the Japanese market.

Regulatory Authorities in Japan

Industry	Regulatory Body
Pharmaceuticals & Medical Devices	Pharmaceuticals and Medical Devices Agency (PMDA) Ministry of Health, Labour, and Welfare (MHLW)
Cosmetics	Ministry of Health, Labour, and Welfare (MHLW)
Nutrition Products	Consumer Affairs Agency (CAA)
Veterinary Medicines	Ministry of Agriculture, Forestry and Fisheries (MAFF)

Regulatory Affairs Lifecycle in Japan

Classifying the product is the most crucial step to register a product in Japan. It allows the companies to understand their product’s approval pathway, the documents required and the responsible regulatory authority. The product can be classified as:

Pharmaceuticals are categorised as OTC, generic, prescription or New Drug Application (NDA)
Biologics are monoclonal antibodies, vaccines, gene therapies, and other cellular and gene-based products
Medical devices are classified as:
- Class 1 : It poses negligible risk to human life and health. Class 1 Medical Devices do not need approval, however PMDA notification is required for the marketing of the product. Example: X-ray film
- Class 2: It poses relatively low risk to human health, but still requires management because if they cause side effects, they could harm human health potentially. Most Class II devices require certification by the Registered Certification Body (RCB), which reviews compliance with relevant standards and conducts Quality Management System (QMS) audits. Devices that do not meet certification standards go through PMDA approval, similar to high-risk devices. Examples: MRI units, dental alloys
- Class 3 & 4 : According to MHLW, class 3 & 4 medical devices require special care as they have potential deadly risk to human health. Applications are submitted to PMDA for review. Example: Pacemaker
Cosmetics are classified as general cosmetics (used for beauty, skin protection, cleansing) and Quasi-drugs (if they contain approved ingredients or functional claims for whitening with anti-inflammatory properties).
Nutrition and health food products fall under Foods with Function Claims (FFC) or Foods for Specified Health Uses (FOSHU), regulated by the Consumer Affairs Agency. Foods making health claims must follow FOSHU or FFC guidelines.
Veterinary products are regulated by the Ministry of Agriculture, Forestry and Fisheries (MAFF), and undergo a similar risk-based review.

As per the laws, Japan requires foreign companies to partner with a local representative to be a common point of contact for regulatory authorities. They are responsible

Appoint a Marketing Authorisation Holder (MAH) for pharmaceuticals, biologics and veterinary drugs
Appoint a Designated Marketing Authorisation Holder (DMAH) for medical devices

Artixio provides MAH/DMAH services and partners with Japan-based representatives for a compliant regulatory process.

All the documents/applications should be submitted in Japanese language irrespective of the product category aligned to the regulatory standards. The following documents are required for product registration in Japan:

Product formulation or composition
Manufacturing details and GMP/QMS certifications
Clinical or preclinical data (as and when required)
Risk management and quality assurance plans
Stability, labeling, and shelf-life information
Localized Instructions for Use (IFU) and labeling
Pharmaceuticals and biologics require submission in eCTD format, including modules for quality, safety, and efficacy.
Medical devices follow the STED (Summary Technical Documentation) format, especially for Class II–IV devices.
Cosmetics must submit ingredient lists, safety data, and labeling, particularly if marketed as quasi-drugs.
Supportive scientific literature or human studies for Nutrition and FOSHU/FFC claims.
Product-specific data (pharmacology, residue studies, animal safety, and efficacy) for Veterinary medicines.

Clinical Trials or bridging studies is essential for innovative drugs, high-risk medical devices or biologics.Instead of complete clinical trials, bridging studies can suffice if the supporting global data is provided to the regulatory authorities.

Submit the application to the regulatory authorities once the pre-submission requirements are carried out. The application is reviewed by the respective regulatory authority for completeness. The review timelines vary with the product type, risk class, and eligibility for fast-track pathways.

The authorities might reject or raise a few queries in case of data/document incompleteness. Once all the requirements are met, the product application is approved and a license or registration certificate is issued.

After the product is approved, it should be import-registered with Japanese customs and regulatory authorities.

Once the product is launched in the market, Japan requires post-marketing compliance which includes safety monitoring (adverse events also known as fuguai), label updates, and regulatory renewals every five years.

Artixio offers end-to-end Regulatory Affairs support for organizations looking to launch their product in Japan. Our experts ensure regulatory clarity, strategic process, and full compliance throughout the product lifecycle. Contact us now to accelerate your product’s journey in Japan!

Why Artixio for Japan’s regulatory affairs

We understand Japan’s unique regulatory environment and help you stay compliant.
Our team works closely with the PMDA and MHLW to handle all the regulatory processes.
With years of experience in Japan, we know the ins and outs of local requirements.
We’ve successfully guided numerous products through Japan’s approval process.
From initial submission to market launch, we’re here to support you every step of the way.

FAQs

What are the most common reasons for rejection or delay by PMDA?

Common reasons for rejections or delays by PMDA include incorrect product classification, poorly translated documents, incomplete clinical, safety or efficacy data or delay in query responses.

What are the main requirements for submitting a product for approval in Japan?

You will need to submit a variety of documentation, including clinical data, safety profiles, manufacturing details, and product labeling, depending on the product type. It’s important to ensure that all documents meet Japanese standards.

What happens after my product is approved in Japan?

Once approved, your product will be registered, and you can begin market distribution. However, ongoing post-market surveillance and reporting are required to monitor product safety and effectiveness.

Is there a fast-track process available for innovative or urgent products?

Yes, Japan offers various fast-track options for certain products which includes:

Sakigake Designation (accelerated review for pioneer products)
Priority Review ( expedited approval for life-threatening conditions)
Conditional Early Approval (serious conditions with limited data)
Orphan Drug/Device Designation (special pathway for rare diseases treatments)

Is a legal presence needed in Japan to register the product?

It is not required to be present in Japan legally for product registration, however a local representative should be hired to hold your market authorization.