PMDA Issues List of Pre-Market Certificates Issued by RCBs in Japan

The PMDA has just recently released a spreadsheet enumerating the pre-market certificates issued by each of the 12 Registered Certification Bodies (RCBs) sanctioned under the Pharmaceutical Affairs Law (PAL), Article 23. This release was in response to a request from the Ministry of Health, Labor, and Welfare (MHLW) to improve the transparency of the agency.  The data covers the certificates issued for each model of designated controlled medical devices, which are low risk, Class II devices, from April 2008 through November 2009.  It is important to note that as a result of issuing separate certificates for each model, rather than one for each device family, the total number of certificates issued is high: 3,520 during a 19 month period.