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.

Registration Code RCB Number of Certificates Issued
AA TUV Sud Japan 592
AB TUV Rheinland Japan 705
AC UL Japan 244
AD BSI Management System Japan 250
AF SGS Japan 447
AG Cosmos Corporation 595
AH Japan Quality Assurance Organization (JQA) 60
AI Nanotec Spindler Co., Ltd. 159
AJ Japan Chemical Quality Assurance Ltd. (JCQA) 3
AK Japan Electrical Safety & Environment Technology Laboratories (JET) 417
AL Japan Association for the Advancement of Medical Equipment (JAAME) 47
AM Fuji Pharma Co., Ltd. 1
TOTAL 3520

Read by 40,000+ device professionals worldwide.

Stay updated on changes to global medical device regulations.RADAR