The Japan Medical Device Nomenclature (JMDN) code is a database for generic medical device descriptions maintained by the Ministry of Health, Labour, and Welfare (MHLW). This system is comparable to the Global Medical Device Nomenclature (GMDN) system or the US Food and Drug Administration (US FDA) system of product codes. GMDN 2003 version serves as the foundation for JMDN, which was first implemented in 2005.
How are devices classified in Japan?
In Japan, medical devices are categorized using a coded predicate system and a risk assessment following the Global Harmonization Task Force (GHTF) classification guidelines. Device classification and registration pathways are identified by JMDN codes. Generally, the categories into which devices are divided are:
- Class I
- Class II
- Class III and
- Class IV
What does the JMDN code include?
The JMDN code includes a general name, definition, risk-based classification, and classification rule based on a GHTF document titled ‘Principles of Medical Devices Classification.’
What information do manufacturers get from the JMDN code?
The important information manufacturers can acquire from the JMDN code is the device classification, information on whether the Quality Management Services (QMS) requirements must be complied with, and applicable authorization and review criteria (e.g., applicable standards) for the device.
How to differentiate JMDN code from GMDN code?
The JMDN code consists of eight (08) digits, whereas the GMDN code consists of five (05) digits. Those starting from 1, 3, or 4 are based on GMDN, and seven (07) is unique to JMDN. The three (03) digits are added after GMDN’s five (05) digits code when GMDN is translated into JMDN.
- 1’s digit shows GHTF classification when divided
- 10’s digit shows a variation (when the original GMDN was too broad and separated into JMDN)
- 100’s digit shows other divisions for Regulatory purposes (containing biological ingredients or drug substances
What should manufacturers do in case of any ambiguity in the classification of devices?
Sometimes, if the classification is unclear, manufacturers must consult the Pharmaceuticals and Medical Devices Agency (PMDA) via consultation call to get clarity on the device classification. Manufacturers can have a meeting with the local metropolitan government.
What if the code doesn’t exist?
If the JMDN code is not available, the device must go through a new device pathway, and classification is based on risk by the standards for classification. However, the MHLW would make the final decision about the device classification.
Who maintains the list of JMDN codes?
The PMDA and Japan Association for the Advancement of Medical Equipment (JAAME) maintains the list of JMDN code.
How do we access the JMDN database to search for the code for our device?
The JMDN database is accessible online via the PMDA website. Initially, the database was only available in Japanese, and now manufacturers can find the English-translated downloadable document on the PMDA’s website.
Manufacturers wishing to market their devices in Japan must carefully plan their Regulatory strategy considering all the critical aspects. Manufacturers facing trouble identifying the JMDN codes for their medical devices can outsource the classification and submission to a reliable Regulatory partner.
To decode more about JMDN code and medical device classification criteria in Japan, reach out to a Regulatory expert like Freyr!