JMDN
yJMDN(Japanese Medical Device Nomenclature)z
gJMDNgwas originally created on basis of 2003 version of GMDN(Global Medical Device Nomenclature) and implemented in 2005. Each medical device is identified by the JMDN.
JMDN includes general name, definition, JMDN code, risk-based classification and classification rule based on a GHTF document titled 'Principles of Medical Devices Classification'.
yNumbering rules of JMDN codez
The relevance between JMDN and GMDN can be confirmed by JMDN code. JMDN code is consist of 8 digits. Those starting from 1, 3 or 4 are based on GMDN and 7 is unique to JMDN. The 3 digits are added after GMDN 5 digits code when GMDN is translated into JMDN.
e.g.)
40937 000 Nuclear medicine system workstation / Based on GMDN
70006 000 Arm type X-ray computed tomography system / Unique to JMDN
The added 3 digits shows the rule of dividing GMDN.
The rule is as follows;
1. In case that added 3 digits is 000, it means the GMDN is not divided.
2. The 1's digit indicates there're differences regarding risk-based classification.
e.g.)
36957001 Body surface stimulator probe / Class T
36957002 Subcutaneous stimulator probe / Class U
36957003 Intramuscular stimulator probe / Class V
36957004 Cardiac/central nerve stimulator / Class W
3. The 10's digit indicates there're no differences regarding risk-based classification.
e.g.)
37626010 Mobile analogue general-purpose diagnostic X-ray system / Class U
37626020 Mobile analogue general-purpose integral diagnostic X-ray system / Class U
4. The 100's digit indicates it contains biological ingredients or drug substances.
e.g.)
10729100 Catheter for central venous
10729200 Catheter for antimicrobial central venous
10729300 Catheter for heparin-coated central venous
10729400 Urokinase-coated central venous catheter