Deep Dive in the Asia Pacific Medical Device Market – Japan
Welcome back to our articles dedicated to emerging market access. This time we will explore Asia Pacific a bit further. This is the fastest-growing region in the global medical devices market valued at over $105 billion (USD) in 2022!
We already looked at market access in some Asia Pacific markets such as India and Singapore in our articles, with these new blogs we’ll take a quick look at a few more Asia Pacific countries, offering an overview of market access for Medical devices. Today we’re focusing on Japan.
The Japanese Medical Device Market
Medical devices imported, sold, and distributed into Japan are regulated by the Pharmaceutical and Medical Device Agency (PMDA) and the Ministry of Health, Labour, and Welfare (MHLW). The two agencies work together to assess the safety and effectiveness of medical products. Medical devices must comply with Japan’s Pharmaceuticals and Medical Devices Act (PMD Act) and MHLW MO169 Quality Management System act, which is aligned with ISO13485:2016 (as of 2021)
Foreign manufacturers must register all manufacturing (and Design) facilities and assign a Marketing Authorisation Holder to deal with all site and device submissions and registration activities on their behalf. The registration pathway is determined by its classification and associated Japan Medical Device Nomenclature (JMDN). The Classification system is more detailed that most international markets, with classification from General Class I, Specified Controlled Class II, Controlled Class II to Specified Highly Controlled Class III/ Highly Controlled Class III/Highly Controlled Class IV.
The registration process for Class I devices is known as ‘Notification’ (Todokede) and is a pre-market application submission procedure with no official PMDA assessment which can be obtained within a week in most cases and incurs no direct costs. All notification applications need to include a detailed device description (measurements, materials used, etc.).
Placing a device on the Japanese market – a checklist:
- Implement/have in place a Quality Management System (QMS) that complies with MHLW Ordinance No. 169.
- Appoint a Marketing Authorization Holder (MAH) or a Designated MAH (DMAH) (Low-risk devices require a MAH, while all other device classes may use a DMAH.
- A Foreign Manufacturer Establishment Registration (FMER) should be submitted by the MAH to the PMDA. (This is a separate process from product registration and is necessary for manufacturers to be able to sell their medical devices in Japan).
- Determine the classification of your device by identifying the appropriate Japanese Medical Device Nomenclature (JMDN) code from the searchable JMDN database.
- The Marketing Authorization Holder (MAH) must register the manufacturer’s device through one of the following procedures.
- Pre-market notification (Todokede) Medical Devices (Class I) will involve a pre-market submission to the PMDA. No review or assessment by the PMDA will be conducted.
- Pre-market certification (Ninsho) Class II (and a limited number of Class III) devices which have an associated certification standard (JIS), are subject to pre-market certification. Many, but not all, Japan Industrial Standards are based on existing ISO/IEC standards.
- Pre-market approval (Shonin) Class II and III devices without a specific certification standard are subject to the pre-market approval process. (This also applies to all Class IV devices. In this case your MAH will file a pre-market approval application with the PMDA and ultimately obtain approval from the MHLW).
Prepare the application forms and required documents for the applicable registration route per the device classification.
- Your MAH submits the application to the PMDA or an RCB (depending on device class) and pays the fees. The application will be reviewed and certification issued on successful application.
- Japan is one of the more challenging markets due to its seemingly complex registration process and potential language difficulties. This can be eased by ensuring you assign an experienced and knowledgeable in market agent who can bridge language and culture barriers.
- Depending on device class, the PMDA or the RCB may conduct a QMS audit and/or application review and may request additional information. Upon approval (except for low-risk devices), the applicable review body will issue a QMS certificate.
Please note these offer a general overview of access routes, full pathways and requirements will vary greatly dependent on device type and risk class amongst other variables.
If you’re interested in placing a device on the Japanese market, do not hesitate to contact us at firstname.lastname@example.org.