Jan 27, 2010
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 | |
The US FDA’s Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER) have issued a notice warning of possible effects the ongoing nuclear disaster in Japan may have on medical device components exported to the US.
The Japan Federation of Medical Device Associations (JFMDA) and the Medical Engineering Technology Industrial Strategy consortium (METIS), Japan’s two largest medical device and technology tr
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 La