茲證明上述醫(yī)療器械已準(zhǔn)許在中國境內(nèi)生產(chǎn)和銷售。 This is to certify that the above medical device(s) have been approved for manufacture and sale in China. 出具出口銷售證明作為服務(wù)事項(xiàng)提供給中國境內(nèi)醫(yī)療器械注冊(cè)人或者備案人。出具出口銷售證明時(shí)，出具證明的部門未評(píng)估或者驗(yàn)證產(chǎn)品是否符合進(jìn)口國家（地區(qū)）的要求，申請(qǐng)人有責(zé)任確保遵守進(jìn)口國家（地區(qū)）的相關(guān)要求。 The Certificate for Exportation is issued as a service item to the Medical Device Registration Certificates or Filing Entities in China. The applicants are obligated to comply with the requirements of the importing countries(regions), as the certifying authority does not evaluate or verify if the products comply with the requirements of the importing countries(regions) when issuing the Certificate for Exportation. *如醫(yī)療器械注冊(cè)證或者產(chǎn)品備案、醫(yī)療器械生產(chǎn)許可證或者生產(chǎn)備案被依法吊銷、撤銷、注銷或者取消的，本證明自吊銷、撤銷、注銷或者取消之日起失效。 *If the Medical Device Registration Certificate, Medical Device Filing Certificate/Filing Number Notification, or the Medical Device Manufacturing License/Filing Certificate is revoked, withdrawn, de-registered or canceled according to law, this Certificate for Exportation shall become invalid from the date of such revocation, withdrawal, de-registration or cancellation. |