公司获北京市药监局颁发医疗器械生产企业许可证。
Reegen received the Manufacturing License from the Beijing FDA Bureau.
本公司已经获得国家医疗器械生产许可证，通过ISO 13485, CE 1023，医疗器械出口证书。
The company has access to national medical equipment production license, through ISO 13485, ce 1023, exports of medical equipment certificate.
第二条《医疗器械经营企业许可证》发证、换证、变更及监督管理适用本办法。
Article 2 These Measures shall apply to the issuance, replacement, modification, supervision and administration of the Permits for Medical Device Operation Enterprises.
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