Are you thinking about marketing your innovative device in Japan? If so, you should know that the Pharmaceuticals and Medical Devices Agency (PMDA) has specific...
PMDA Issues List of Pre-Market Certificates Issued by RCBs in Japan
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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 | |