醫(yī)療器械注冊(cè)管理辦法中英文翻譯[共48頁]

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1、醫(yī)療器械注冊(cè)管理辦法Medical Devices Registration Administration Method總則Chapter 1 General Provisions第一條為規(guī)范醫(yī)療器械的注冊(cè)管理，保證醫(yī)療器械的安全、有效，根據(jù)醫(yī)療器械監(jiān)督管理?xiàng)l例，制定本辦法。Article 1 To regulate medical device registration management and ensure their safety and effectiveness of medical device, we set down the management measure accor

2、ding to Regulations for the Supervision and Administration of Medical Device.第二條在中華人民共和國境內(nèi)銷售、使用的醫(yī)療器械均應(yīng)當(dāng)按照本辦法的規(guī)定申請(qǐng)注冊(cè)，未獲準(zhǔn)注冊(cè)的醫(yī)療器械，不得銷售、使用。 Article 2 All the medical device which would like to sell and use within the territory of the Peoples Republic of China shall apply for registration complying with

3、this measure. These medical devices which not get China registration approval should be prohibited to sell and use. 第三條醫(yī)療器械注冊(cè)，是指依照法定程序，對(duì)擬上市銷售、使用的醫(yī)療器械的安全性、有效性進(jìn)行系統(tǒng)評(píng)價(jià)，以決定是否同意其銷售、使用的過程。Article 3 Medical device registration is the process of doing systemic evaluation of plan-market medical device on thei

4、r safety and effectiveness, then decide if medical device can be allowed to sell and use. 第四條國家對(duì)醫(yī)療器械實(shí)行分類注冊(cè)管理。 Article 4 The state shall classify medical devices and administer them based on this classification. 境內(nèi)第一類醫(yī)療器械由設(shè)區(qū)的市級(jí)（食品）藥品監(jiān)督管理機(jī)構(gòu)審查，批準(zhǔn)后發(fā)給醫(yī)療器械注冊(cè)證書。Domestic Class I medical devices shall be ins

5、pected, approved and granted with a registration certificate by the food drug regulatory authority of the government of the municipalities consisting of districts. 境內(nèi)第二類醫(yī)療器械由省、自治區(qū)、直轄市（食品）藥品監(jiān)督管理部門審查，批準(zhǔn)后發(fā)給醫(yī)療器械注冊(cè)證書。Domestic Class II medical devices shall be inspected, approved and granted with a regist

6、ration certificate by the food drug regulatory authorities of provinces, autonomous regions and municipalities directly under the central government. 境內(nèi)第三類醫(yī)療器械由國家食品藥品監(jiān)督管理局審查，批準(zhǔn)后發(fā)給醫(yī)療器械注冊(cè)證書。Domestic Class III medical device shall be inspected, approved and granted with registration certificate by Stat

7、e Food Drug Administration.境外醫(yī)療器械由國家食品藥品監(jiān)督管理局審查，批準(zhǔn)后發(fā)給醫(yī)療器械注冊(cè)證書。Imported medical devices shall be inspected, approved and granted with registration certificate by State Food Drug Administration. 臺(tái)灣、香港、澳門地區(qū)醫(yī)療器械的注冊(cè)，除本辦法另有規(guī)定外，參照境外醫(yī)療器械辦理。Taiwan, Hongkong and Macaos medical device registration shall refer

8、to the regulation of imported medical device.醫(yī)療器械注冊(cè)證書有效期4年。Medical devices certificate is valid for 4 years. 第五條醫(yī)療器械注冊(cè)證書由國家食品藥品監(jiān)督管理局統(tǒng)一印制，相應(yīng)內(nèi)容由審批注冊(cè)的（食品）藥品監(jiān)督管理部門填寫。Article 5 Medical devices registration certificate shall be pressed by State Food Drug Administration and the content shall be filled in b

9、y inspection department of food drug administration.注冊(cè)號(hào)的編排方式為： Registration is arranged as the following:（）1(食)藥監(jiān)械（2）字3第456號(hào)。其中： X (X) 1 SFDA (X2) 字3第456號(hào)1 為注冊(cè)審批部門所在地的簡稱：X 1 : Shortened form of registration inspection department s locus 境內(nèi)第三類醫(yī)療器械、境外醫(yī)療器械以及臺(tái)灣、香港、澳門地區(qū)的醫(yī)療器械為“國”字；“國” is for domestic Clas

10、s III medical devices, imported medical devices and medical devices of Taiwan, Hongkong and Macao. 境內(nèi)第二類醫(yī)療器械為注冊(cè)審批部門所在的省、自治區(qū)、直轄市簡稱；境內(nèi)第一類醫(yī)療器械為注冊(cè)審批部門所在的省、自治區(qū)、直轄市簡稱加所在設(shè)區(qū)的市級(jí)行政區(qū)域的簡稱，為1（無相應(yīng)設(shè)區(qū)的市級(jí)行政區(qū)域時(shí)，僅為省、自治區(qū)、直轄市的簡稱）； 2為注冊(cè)形式（準(zhǔn)、進(jìn)、許）： “準(zhǔn)”字適用于境內(nèi)醫(yī)療器械；“進(jìn)”字適用于境外醫(yī)療器械；“許”字適用于臺(tái)灣、香港、澳門地區(qū)的醫(yī)療器械；3為批準(zhǔn)注冊(cè)年份；4為產(chǎn)品管理類別；5為產(chǎn)品品種

11、編碼； 6為注冊(cè)流水號(hào)。 醫(yī)療器械注冊(cè)證書附有醫(yī)療器械注冊(cè)登記表（見本辦法附件1），與醫(yī)療器械注冊(cè)證書同時(shí)使用。Medical device registration certificate is attached with medical device registration record, and shall be used along with medical device registration certificate.第六條生產(chǎn)企業(yè)提出醫(yī)療器械注冊(cè)申請(qǐng)，承擔(dān)相應(yīng)的法律義務(wù)，并在該申請(qǐng)獲得批準(zhǔn)后持有醫(yī)療器械注冊(cè)證書。Manufacturers put forward medical

12、 device registration application, take relevant regal responsibility and keep medical device registration certificate after getting application approval. 辦理醫(yī)療器械注冊(cè)申請(qǐng)事務(wù)的人員應(yīng)當(dāng)受生產(chǎn)企業(yè)委托，并具有相應(yīng)的專業(yè)知識(shí)，熟悉醫(yī)療器械注冊(cè)管理的法律、法規(guī)、規(guī)章和技術(shù)要求。Individuals who do medical device registration application should be authorized by ma

13、nufacturer, possess professional knowledge, are familiar with medical device registration administration law, regulation, rules and technical requirement. 申請(qǐng)境外醫(yī)療器械注冊(cè)的，境外生產(chǎn)企業(yè)應(yīng)當(dāng)在中國境內(nèi)指定機(jī)構(gòu)作為其代理人，代理人應(yīng)當(dāng)承擔(dān)相應(yīng)的法律責(zé)任；并且，境外生產(chǎn)企業(yè)應(yīng)當(dāng)委托中國境內(nèi)具有相應(yīng)資格的法人機(jī)構(gòu)或者委托其在華機(jī)構(gòu)承擔(dān)醫(yī)療器械售后服務(wù)。When doing imported medical devices registrati

14、on, the overseas manufactures shall authorize an unit to be their agent in Chinese territory and the agent should take relevant legal responsibilities. Meanwhile overseas manufactures shall authorize qualified body corporate or theirs own organ located in China to do after sales service. 第七條申請(qǐng)注冊(cè)的醫(yī)療器

15、械，應(yīng)當(dāng)有適用的產(chǎn)品標(biāo)準(zhǔn)，可以采用國家標(biāo)準(zhǔn)、行業(yè)標(biāo)準(zhǔn)或者制定注冊(cè)產(chǎn)品標(biāo)準(zhǔn)，但是注冊(cè)產(chǎn)品標(biāo)準(zhǔn)不得低于國家標(biāo)準(zhǔn)或者行業(yè)標(biāo)準(zhǔn)。Article 7 Medical devices which applying for registration shall have suitable product standard that can adopt state standard, industry standard or edit registration standard, but registration standard should not inferior to state standard o

16、r industry standard. 注冊(cè)產(chǎn)品標(biāo)準(zhǔn)應(yīng)當(dāng)依據(jù)國家食品藥品監(jiān)督管理局規(guī)定的醫(yī)療器械標(biāo)準(zhǔn)管理要求編制。Registration standard shall be edited according to medical device standard administration regulation stipulated by state food drug supervision administration. 第八條申請(qǐng)第二類、第三類醫(yī)療器械注冊(cè)，生產(chǎn)企業(yè)應(yīng)當(dāng)符合國家食品藥品監(jiān)督管理局規(guī)定的生產(chǎn)條件或者相關(guān)質(zhì)量體系要求。Article 8 Applying for Clas

17、s II and Class III medical device registration, manufacture shall comply with relevant manufacturing condition or quality system requirement stipulated by state food drug supervision administration. 第二章 醫(yī)療器械注冊(cè)檢測Chapter 2 Medical devices registration testing 第九條第二類、第三類醫(yī)療器械由國家食品藥品監(jiān)督管理局會(huì)同國家質(zhì)量監(jiān)督檢驗(yàn)檢疫總局認(rèn)可

18、的醫(yī)療器械檢測機(jī)構(gòu)進(jìn)行注冊(cè)檢測，經(jīng)檢測符合適用的產(chǎn)品標(biāo)準(zhǔn)后，方可用于臨床試驗(yàn)或者申請(qǐng)注冊(cè)。Article 9 Class II and Class III medical devices shall be tested by medical device testing organization approbated by State Food Drug Supervision Administration and State Quality Supervision Inspection and Quarantine, then can be used in clinical trial or

19、 apply for registration. 經(jīng)國家食品藥品監(jiān)督管理局會(huì)同國家質(zhì)量監(jiān)督檢驗(yàn)檢疫總局認(rèn)可的醫(yī)療器械檢測機(jī)構(gòu)（以下簡稱醫(yī)療器械檢測機(jī)構(gòu)）目錄另行發(fā)布。The list of medical device testing organization approbated by State Food Drug Supervision Administration and State Quality Supervision Inspection and Quarantine (medical device testing organization for short in the fo

20、llowing) shall be issued at another time. 第十條醫(yī)療器械檢測機(jī)構(gòu)應(yīng)當(dāng)在國家食品藥品監(jiān)督管理局和國家質(zhì)量監(jiān)督檢驗(yàn)檢疫總局認(rèn)可的檢測范圍內(nèi)，依據(jù)生產(chǎn)企業(yè)申報(bào)適用的產(chǎn)品標(biāo)準(zhǔn)（包括適用的國家標(biāo)準(zhǔn)、行業(yè)標(biāo)準(zhǔn)或者生產(chǎn)企業(yè)制定的注冊(cè)產(chǎn)品標(biāo)準(zhǔn)）對(duì)申報(bào)產(chǎn)品進(jìn)行注冊(cè)檢測，并出具檢測報(bào)告。Article 10 Medical device testing organization should do registration testing on applicant products according to available product standard inclu

21、ding state standard, industry standard or registration product standards edited by manufacture within the specific testing range approbated by State Food Drug Supervision Administration and State Quality Supervision Inspection and Quarantine. 尚未列入各醫(yī)療器械檢測機(jī)構(gòu)授檢范圍的醫(yī)療器械，由相應(yīng)的注冊(cè)審批部門指定有承檢能力的檢測單位進(jìn)行檢測。For the

22、 medical device that have not been listed in testing range of all medical device testing organization should be tested by qualified testing united approbated by registration inspection department. 境外醫(yī)療器械的注冊(cè)檢測執(zhí)行境外醫(yī)療器械注冊(cè)檢測規(guī)定。Imported medical device registration shall perform “Imported Medical Device R

23、egistration Testing Regulation”.第十一條同一注冊(cè)單元內(nèi)所檢測的產(chǎn)品應(yīng)當(dāng)是能夠代表本注冊(cè)單元內(nèi)其他產(chǎn)品安全性和有效性的典型產(chǎn)品。Among one testing unit the tested product should be the typical product that can representing the safety and effectiveness of other products. 第十二條同一生產(chǎn)企業(yè)使用相同原材料生產(chǎn)的同類產(chǎn)品，如果生產(chǎn)工藝和預(yù)期用途保持不變，重新注冊(cè)時(shí)，對(duì)產(chǎn)品的生物學(xué)評(píng)價(jià)可以不再進(jìn)行生物相容性試驗(yàn)。For re-re

24、gistration the same kind products which made of same material and manufactured by one manufacturer would not be tested for biological compatibility item during biological evaluation if manufacturing technics and intended use do not change. 同一生產(chǎn)企業(yè)使用已經(jīng)通過生物學(xué)評(píng)價(jià)的原材料生產(chǎn)的同類產(chǎn)品，如果生產(chǎn)工藝保持不變，預(yù)期用途保持不變或者沒有新增的潛在生物學(xué)

25、風(fēng)險(xiǎn)，申請(qǐng)注冊(cè)時(shí)，對(duì)產(chǎn)品的生物學(xué)評(píng)價(jià)可以不再進(jìn)行生物相容性試驗(yàn)。When register the products which manufactured by one manufacturer, made of same material that have done biological evaluation and do not change their manufacturing technics, intended use and have no new potential biological risk would not be tested for biological comp

26、atibility during biological evaluation. 第十三條申請(qǐng)第二類、第三類醫(yī)療器械注冊(cè)，同時(shí)滿足以下條件的，可以免予注冊(cè)檢測：Applying for Class II and Class III medical device registration will be exempted of doing registration testing if satisfy the following conditions:（一）所申請(qǐng)注冊(cè)的醫(yī)療器械與本企業(yè)已經(jīng)獲準(zhǔn)注冊(cè)的醫(yī)療器械的基本原理，主要功能、結(jié)構(gòu)，所用材料、材質(zhì)，預(yù)期用途屬于同一類；Applying medic

27、al device and applied medical device is same in the basic principle, main function, structure, material and intended use.（二）生產(chǎn)企業(yè)已經(jīng)通過醫(yī)療器械生產(chǎn)質(zhì)量管理規(guī)范檢查或者已經(jīng)獲得醫(yī)療器械質(zhì)量體系認(rèn)證，并且生產(chǎn)企業(yè)能夠提供經(jīng)原企業(yè)生產(chǎn)條件審查機(jī)構(gòu)認(rèn)可的檢測報(bào)告；The manufacturers have passed the medical device manufacturing quality administration regulation testing or

28、 get approval of medical device quality system certification, meanwhile the manufacturers can provide the admissive testing report by inspection institution under former manufacturing condition. （三）所申請(qǐng)注冊(cè)的醫(yī)療器械與本企業(yè)已經(jīng)獲準(zhǔn)注冊(cè)并且已經(jīng)通過注冊(cè)檢測的同類產(chǎn)品比較，未發(fā)生涉及安全性、有效性改變，或者雖然涉及安全性、有效性改變，但是改變部分和由其引起產(chǎn)品其他相關(guān)安全性、有效性變化的部分都已經(jīng)通

29、過了醫(yī)療器械檢測機(jī)構(gòu)檢測；Comparing with approved registration medical devices , the same kind of applying medical devices do not have changes concerning safety and effectiveness areas or despite of having changes concerning safety and effectiveness areas which have been tested by medical device testing institut

30、ion. （四）已經(jīng)獲準(zhǔn)注冊(cè)的本企業(yè)同類產(chǎn)品按照規(guī)定進(jìn)行醫(yī)療器械不良事件監(jiān)測，并且未發(fā)現(xiàn)嚴(yán)重不良事件；The same kind of approved registration medical devices have not been found adverse events in the process of MDR.（五）已經(jīng)獲準(zhǔn)注冊(cè)的本企業(yè)同類產(chǎn)品1年內(nèi)無（食品）藥品監(jiān)督管理部門產(chǎn)品質(zhì)量監(jiān)督抽查不合格記錄；The same kind of approved registration medical devices have not been found ineligible reco

31、rds in the process of product quality selective examination by food drug supervision administration within one year. （六）境外醫(yī)療器械已經(jīng)通過境外政府醫(yī)療器械主管部門的上市批準(zhǔn)。Overseas medical devices have got pre-market approval by overseas medical device supervision government. 第十四條申請(qǐng)第二類、第三類醫(yī)療器械產(chǎn)品重新注冊(cè)，同時(shí)滿足以下條件的，可以免予注冊(cè)檢測：Appl

32、ying for Class II and Class III medical device re-registration will be exempted of doing registration testing if satisfy the following conditions:（一）申請(qǐng)重新注冊(cè)的醫(yī)療器械與本企業(yè)已經(jīng)獲準(zhǔn)注冊(cè)的醫(yī)療器械的基本原理，主要功能、結(jié)構(gòu)，所用材料、材質(zhì)，預(yù)期用途屬于同一類；Applying re-registration medical device and applied medical device is same in the basic princ

33、iple, main function, structure, material and intended use.（二）生產(chǎn)企業(yè)已經(jīng)通過醫(yī)療器械生產(chǎn)質(zhì)量管理規(guī)范檢查或者已經(jīng)獲得醫(yī)療器械質(zhì)量體系認(rèn)證，并且生產(chǎn)企業(yè)能夠提供經(jīng)原企業(yè)生產(chǎn)條件審查機(jī)構(gòu)認(rèn)可的檢測報(bào)告；The manufacturers have passed the medical device manufacturing quality administration regulation testing or get approval of medical device quality system certification, m

34、eanwhile the manufacturers can provide the admissive testing report by inspection institution under former manufacturing condition. （三）申請(qǐng)重新注冊(cè)的醫(yī)療器械與已經(jīng)通過注冊(cè)檢測的原注冊(cè)產(chǎn)品相比較，未發(fā)生涉及安全性、有效性改變，或者雖然涉及安全性、有效性改變，但是改變部分和由其引起產(chǎn)品其他相關(guān)安全性、有效性變化的部分都已經(jīng)通過了醫(yī)療器械檢測機(jī)構(gòu)檢測；Comparing with approved registration medical devices , the

35、 same kind of applying re-registration medical devices do not have changes concerning safety and effectiveness areas or despite of having changes concerning safety and effectiveness areas which have been tested by medical device testing institution. （四）申請(qǐng)重新注冊(cè)的醫(yī)療器械在原醫(yī)療器械注冊(cè)證書有效期內(nèi)按照規(guī)定進(jìn)行醫(yī)療器械不良事件監(jiān)測，并且未發(fā)現(xiàn)

36、不良事件；Applying for re-registration medical devices have not been found adverse events in the process of MDR within the expiration date of the former medical device certificate.（五）原注冊(cè)醫(yī)療器械1年內(nèi)無（食品）藥品監(jiān)督管理部門產(chǎn)品質(zhì)量監(jiān)督抽查不合格記錄。The former approved registration medical devices have not been found ineligible recor

37、ds in the process of product quality selective examination by food drug supervision administration within one year. 第十五條已經(jīng)通過境外政府醫(yī)療器械主管部門的上市批準(zhǔn)、對(duì)安裝場地有特殊要求、檢測困難的大型醫(yī)療器械，可以申請(qǐng)暫緩檢測，于取得醫(yī)療器械注冊(cè)證書后再對(duì)產(chǎn)品進(jìn)行補(bǔ)充檢測。Huge medical equipments which have got pre-market notification by overseas medical device supervision d

38、epartment, need special requirements on spot installation and have difficulty for testing can applying for postpone testing can be done supplement testing after getting medical device certificate. 根據(jù)前款規(guī)定申請(qǐng)暫緩檢測而獲準(zhǔn)注冊(cè)的產(chǎn)品，生產(chǎn)企業(yè)必須在首臺(tái)醫(yī)療器械入境后、投入使用前完成注冊(cè)檢測。經(jīng)檢測合格后方可投入使用。For the products satisfied with above re

39、gulation that get registration approval when applying for postpone testing, the manufacture shall complete registration testing after importing the first medical device, until the testing is eligible the product can be put into use. 第三章 醫(yī)療器械臨床試驗(yàn)Chapter 3 Medical device clinical trial 第十六條申請(qǐng)第二類、第三類醫(yī)療

40、器械注冊(cè)，應(yīng)當(dāng)提交臨床試驗(yàn)資料。When applying for Class II and Class III medical devices registration, clinical trial material should be submitted.臨床試驗(yàn)資料提供方式執(zhí)行醫(yī)療器械注冊(cè)臨床試驗(yàn)資料分項(xiàng)規(guī)定（見本辦法附件12）。The submission methods of clinical trial material shall comply to Medical Device Registration on Clinical Trial Material Itemize R

41、egulation.(Refer to attachment 12)第十七條 在中國境內(nèi)進(jìn)行醫(yī)療器械臨床試驗(yàn)的，應(yīng)當(dāng)嚴(yán)格執(zhí)行醫(yī)療器械臨床試驗(yàn)規(guī)定。The clinical trial processed in China shall strictly comply to Medical Device Clinical Trial Regulation.第十八條在中國境內(nèi)進(jìn)行臨床試驗(yàn)的醫(yī)療器械，其臨床試驗(yàn)資料中應(yīng)當(dāng)包括臨床試驗(yàn)合同、臨床試驗(yàn)方案、臨床試驗(yàn)報(bào)告。The clinical trial material of medical devices processed in China sha

42、ll include clinical trail agreement, clinical trial project and clinical trial report. （食品）藥品監(jiān)督管理部門認(rèn)為必要時(shí)，可以要求生產(chǎn)企業(yè)提交臨床試驗(yàn)須知、知情同意書以及臨床試驗(yàn)原始記錄。Food drug supervision administration could ask manufacture to provide clinical trial memorandum, acknowledgment letter and clinical trial original records.第四章 醫(yī)療器

43、械注冊(cè)申請(qǐng)與審批Chapter 4 Medical device registration application and inspection第十九條申請(qǐng)醫(yī)療器械注冊(cè)，申請(qǐng)人應(yīng)當(dāng)根據(jù)醫(yī)療器械的分類，向本辦法第四條規(guī)定的相應(yīng)（食品）藥品監(jiān)督管理部門提出申請(qǐng)，并應(yīng)當(dāng)填寫醫(yī)療器械注冊(cè)申請(qǐng)表，按照本辦法附件2、附件3、附件6、附件8或者附件9的相應(yīng)要求提交申請(qǐng)材料。申請(qǐng)材料應(yīng)當(dāng)使用中文；根據(jù)外文資料翻譯的申請(qǐng)材料，應(yīng)當(dāng)同時(shí)提供原文。When applying for medical devices registration, applicants shall accord with the medi

44、cal device classification and apply to concerning food drug supervision administration according to item 4 of this methods.申請(qǐng)人提交的醫(yī)療器械說明書應(yīng)當(dāng)符合醫(yī)療器械說明書、標(biāo)簽和包裝標(biāo)識(shí)管理規(guī)定。Medical device user manual submitted by applicants shall accord with Administration Regulation of Medical Device user manual, labeling and p

45、ackage .申請(qǐng)人應(yīng)當(dāng)對(duì)其申請(qǐng)材料全部內(nèi)容的真實(shí)性負(fù)責(zé)。Applicants shall take the responsibility of the truth about the fully application material. 第二十條 （食品）藥品監(jiān)督管理部門收到申請(qǐng)后，應(yīng)當(dāng)根據(jù)下列情況分別作出處理：Food drug supervision administration shall treat respectively depending on the following conditions:（一）申請(qǐng)事項(xiàng)依法不屬于本部門職權(quán)范圍的，應(yīng)當(dāng)即時(shí)作出不予受理的決定，并告知申請(qǐng)

46、人向有關(guān)行政機(jī)關(guān)申請(qǐng)；If application articles legally do not belong to authorized scope of this department, should issue a rejection notice and advance applicants to apply for concerning administration unit. （二）申請(qǐng)材料存在可以當(dāng)場更正的錯(cuò)誤的，應(yīng)當(dāng)允許申請(qǐng)人當(dāng)場更正；If there is mistake in the application material that could be correct o

47、n-spot, the applicants shall be permitted to correct on spot. （三）申請(qǐng)材料不齊全或者不符合形式審查要求的，應(yīng)當(dāng)當(dāng)場或者在5個(gè)工作日內(nèi)發(fā)給申請(qǐng)人補(bǔ)正材料通知書，一次性告知申請(qǐng)人需要補(bǔ)正的全部內(nèi)容，逾期不告知的，自收到申請(qǐng)材料之日起即為受理；If the application material is incomplete or not in accord with formal inspection requirement, please inform applicant on-spot or issue applicant wit

48、h Supplement Material Notice Letter within 5 workdays and inform applicant all the requested supplementary material at one time. Without informing within appointed period, the material receiving date should be regarded as the acceptance date. （四）申請(qǐng)材料齊全、符合形式審查要求的，或者申請(qǐng)人按照要求提交全部補(bǔ)正申請(qǐng)材料的，予以受理。It should b

49、e accepted if the application material is complete, accord with formal inspection request or applicants submit all requested supplement material according to the concerning requirements. （食品）藥品監(jiān)督管理部門受理或者不予受理醫(yī)療器械注冊(cè)申請(qǐng)，應(yīng)當(dāng)出具加蓋本部門專用印章并注明日期的受理通知書或者不予受理通知書。Whatever food drug supervision administration acce

50、pt medical devices application or not, an acceptance notice or a rejection letter should be issued by department with special seal and date. 第二十一條（食品）藥品監(jiān)督管理部門受理醫(yī)療器械注冊(cè)申請(qǐng)后，應(yīng)當(dāng)在本辦法第二十二條規(guī)定的期限內(nèi)對(duì)申請(qǐng)進(jìn)行實(shí)質(zhì)性審查并作出是否給予注冊(cè)的書面決定。經(jīng)審查符合規(guī)定批準(zhǔn)注冊(cè)的，自書面批準(zhǔn)決定作出之日起10個(gè)工作日內(nèi)發(fā)給醫(yī)療器械注冊(cè)證書。經(jīng)審查不符合規(guī)定的，作出不予注冊(cè)的書面決定，并說明理由，同時(shí)告知申請(qǐng)人享有依法申請(qǐng)行政復(fù)議

51、或者提起行政訴訟的權(quán)利。Food drug supervision administration shall do substantiality inspection on application and make a paper decision on whether administer registration according to the stipulated term in item 22 of this method. On the condition that material accords with inspection regulation and administer

52、 registration, medical device registration certificates shall be issued within 10 workdays counted from date of the paper approval decision-making. 第二十二條設(shè)區(qū)的市級(jí)（食品）藥品監(jiān)督管理機(jī)構(gòu)應(yīng)當(dāng)自受理申請(qǐng)之日起30個(gè)工作日內(nèi)，作出是否給予注冊(cè)的決定。 Food Drug regulatory authority of the government of the municipalities consisting of districts shal

53、l make a division whether to administer registration within 30 workdays from the date of application. 省、自治區(qū)、直轄市（食品）藥品監(jiān)督管理部門應(yīng)當(dāng)自受理申請(qǐng)之日起60個(gè)工作日內(nèi)，作出是否給予注冊(cè)的決定。 Food Drug regulatory authorities of the provinces, autonomous regions and municipalities shall make a division whether to administer registration

54、within 60 workdays form the date of application. 國家食品藥品監(jiān)督管理局應(yīng)當(dāng)自受理申請(qǐng)之日起90個(gè)工作日內(nèi)，作出是否給予注冊(cè)的決定。Food Drug regulatory authority directly under State Council shall make a make a division whether to administer registration within 90 workdays form the date of application. 在對(duì)注冊(cè)申請(qǐng)進(jìn)行審查的過程中，需要檢測、專家評(píng)審和聽證的，所需時(shí)間不計(jì)算在

55、本條規(guī)定的期限內(nèi)。（食品）藥品監(jiān)督管理部門應(yīng)當(dāng)將所需時(shí)間書面告知申請(qǐng)人。In the process of inspection, if testing, technical review by specialists and audit are needed, the requested time is besides from the regulated period of this article. Food Drug Administration shall inform applicants with paper notice about the needed time. 第二十三條

56、未獲得境外醫(yī)療器械上市許可的境外醫(yī)療器械，申請(qǐng)注冊(cè)時(shí)，參照境內(nèi)同類產(chǎn)品注冊(cè)的技術(shù)審查要求執(zhí)行（需要提交的材料見本辦法附件8、附件9）。When apply for registration, the imported medical devices without marketing permission at overseas shall refer to registration technical inspection requirements of the domestic products in the same kind (the requested submission mate

57、rial shall refer to attachment 8 and attachment 9). 第二十四條（食品）藥品監(jiān)督管理部門在對(duì)醫(yī)療器械注冊(cè)申請(qǐng)材料進(jìn)行技術(shù)審查時(shí)，需要生產(chǎn)企業(yè)補(bǔ)充材料的，應(yīng)當(dāng)一次性發(fā)出書面補(bǔ)充材料通知。In the inspection process of medical devices registration application material, SFDA shall issue paper supplementary notice to manufacture at one time if supplementary material is nee

58、ded. 生產(chǎn)企業(yè)應(yīng)當(dāng)在60個(gè)工作日內(nèi)按照通知要求將材料一次性補(bǔ)齊，補(bǔ)充材料的時(shí)間不計(jì)算在（食品）藥品監(jiān)督管理部門進(jìn)行實(shí)質(zhì)審查的期限內(nèi)。生產(chǎn)企業(yè)未能在規(guī)定的時(shí)限內(nèi)補(bǔ)充材料且沒有正當(dāng)理由的，終止審查。Manufacture shall submit all the requested supplementary material at one time according to requirement within 60 workdays. The additional time can not be counted to the SFDAs substantial inspection tim

59、e. Inspection shall be discontinued that manufactures do not supplement the requested material within regulated time and have no allowable reason. 第二十五條注冊(cè)申請(qǐng)被終止審查的，在被終止審查后的6個(gè)月內(nèi)不得再次申請(qǐng)。For the discontinued inspection, re-registration should not applied within 6 months from the discontinued date. 第二十六條生

60、產(chǎn)企業(yè)對(duì)補(bǔ)充材料通知內(nèi)容有異議的，可以在規(guī)定的時(shí)限內(nèi)向（食品）藥品監(jiān)督管理部門提出書面意見，說明理由并提供技術(shù)支持材料，經(jīng)（食品）藥品監(jiān)督管理部門審查后作出決定。If manufactures have suspicion for the supplementary material notice, a paper suggestion can be advanced to SFDA at limited time, explain excuse and offer technical supporting material that shall be inspected by SFDA, f

61、inally SFDA will give a decision. 第二十七條醫(yī)療器械產(chǎn)品的注冊(cè)單元原則上以技術(shù)結(jié)構(gòu)、性能指標(biāo)和預(yù)期用途為劃分依據(jù)。Basically the classification basis of medical devices registration unit is technological structure, performance and intended use. 第二十八條作為部件注冊(cè)的醫(yī)療器械，申請(qǐng)人應(yīng)當(dāng)說明與該部件配合使用的推薦產(chǎn)品、部件的名稱、型號(hào)、規(guī)格。For medical devices registered as parts, appli

62、cants shall explain the recommended products, parts name, model and specifications to work with them. 已經(jīng)獲準(zhǔn)注冊(cè)的部件組合成的整機(jī)，必須履行整機(jī)注冊(cè)手續(xù)。 A complete machine combined with all registered parts shall implement complete unit registration procedure. 以整機(jī)注冊(cè)的醫(yī)療器械，申請(qǐng)注冊(cè)時(shí)應(yīng)當(dāng)列出其主要配置。如果某個(gè)主要配置部件性能規(guī)格發(fā)生改變，整機(jī)應(yīng)當(dāng)重新注冊(cè)。 When me

63、dical devices registering as a complete unit, its main deployment should be listed. A new re-registration should be requested if the main deployments change their performance and specifications. 以整機(jī)注冊(cè)的醫(yī)療器械，其醫(yī)療器械注冊(cè)證書附表中的“產(chǎn)品性能結(jié)構(gòu)及組成”欄內(nèi)所列出的組合部件在不改變組合形式和預(yù)期用途的情況下單獨(dú)銷售的，可以免予單獨(dú)注冊(cè)。If the combination parts whi

64、ch have been registered as a complete unit listed on column performance, structure and components of the product of the Medical Device Registration Record would be allowed to exempt from sole registration when be sold solely without changing its combination form and intended use. 第二十九條（食品）藥品監(jiān)督管理部門應(yīng)當(dāng)在行政機(jī)關(guān)的網(wǎng)站和醫(yī)療器械注冊(cè)辦公場所公示相應(yīng)的