醫(yī)療器械注冊管理辦法中英文翻譯

1、醫(yī)療器械注冊管理辦法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)督管理條例，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)當按照本辦法的規(guī)定申請注冊，未獲準注冊的醫(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，是指依照法定程序，對擬上市銷售、使用的醫(yī)療器械的安全性、有效性進行系統(tǒng)評價，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. 第四條國家對醫(yī)療器械實行分類注冊管理。 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（食品）藥品監(jiān)督管理機構(gòu)審查，批準后發(fā)給醫(yī)療器械注冊證書。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，批準后發(fā)給醫(yī)療器械注冊證書。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，批準后發(fā)給醫(yī)療器械注冊證書。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，批準后發(fā)給醫(yī)療器械注冊證書。Imported medical devices shall be inspected, approved and granted with registration certificate by State Food Drug Administration. 臺灣、香港、澳門地區(qū)醫(yī)療器械的注冊，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.注冊號的編排方式為： Registration is arranged as the following:×（×）1(食)藥監(jiān)械（×2）字××××3第×4××5××××6號。其中： X (X) 1 SFDA (X2) 字××××3第×4××5×××

10、5;6號×1 為注冊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)療器械以及臺灣、香港、澳門地區(qū)的醫(yī)療器械為“國”字；“國” is for domestic Class 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)療器械為注冊審批

11、部門所在的省、自治區(qū)、直轄市簡稱加所在設(shè)區(qū)的市級行政區(qū)域的簡稱，為××1（無相應(yīng)設(shè)區(qū)的市級行政區(qū)域時，僅為省、自治區(qū)、直轄市的簡稱）； ×2為注冊形式（準、進、許）： “準”字適用于境內(nèi)醫(yī)療器械；“進”字適用于境外醫(yī)療器械；“許”字適用于臺灣、香港、澳門地區(qū)的醫(yī)療器械；××××3為批準注冊年份；×4為產(chǎn)品管理類別；××5為產(chǎn)品品種編碼； ××××6為注冊流水號。 醫(yī)療器械注冊證書附有醫(yī)療器械注冊登記表（見本辦法附件1），與醫(yī)療器械注冊證書同時使用。Medi

12、cal 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)療器械注冊申請，承擔相應(yīng)的法律義務(wù)，并在該申請獲得批準后持有醫(yī)療器械注冊證書。Manufacturers put forward medical device registration application, take relevant regal respon

13、sibility and keep medical device registration certificate after getting application approval. 辦理醫(yī)療器械注冊申請事務(wù)的人員應(yīng)當受生產(chǎn)企業(yè)委托，并具有相應(yīng)的專業(yè)知識，熟悉醫(yī)療器械注冊管理的法律、法規(guī)、規(guī)章和技術(shù)要求。Individuals who do medical device registration application should be authorized by manufacturer, possess professional knowledge, are familiar wit

14、h medical device registration administration law, regulation, rules and technical requirement. 申請境外醫(yī)療器械注冊的，境外生產(chǎn)企業(yè)應(yīng)當在中國境內(nèi)指定機構(gòu)作為其代理人，代理人應(yīng)當承擔相應(yīng)的法律責任；并且，境外生產(chǎn)企業(yè)應(yīng)當委托中國境內(nèi)具有相應(yīng)資格的法人機構(gòu)或者委托其在華機構(gòu)承擔醫(yī)療器械售后服務(wù)。When doing imported medical devices registration, the overseas manufactures shall authorize an unit to be

15、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. 第七條申請注冊的醫(yī)療器械，應(yīng)當有適用的產(chǎn)品標準，可以采用國家標準、行業(yè)標準或者制定注冊產(chǎn)品標準，但是注冊產(chǎn)品標準不得低于國家標準或者行業(yè)標準。

16、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 or industry standard. 注冊產(chǎn)品標準應(yīng)當依據(jù)國家食品藥品監(jiān)督管理局規(guī)定的醫(yī)療器械標準管理要求編制。Re

17、gistration standard shall be edited according to medical device standard administration regulation stipulated by state food drug supervision administration. 第八條申請第二類、第三類醫(yī)療器械注冊，生產(chǎn)企業(yè)應(yīng)當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 Class II and Class III medical device registration, manufacture

18、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)督管理局會同國家質(zhì)量監(jiān)督檢驗檢疫總局認可的醫(yī)療器械檢測機構(gòu)進行注冊檢測，經(jīng)檢測符合適用的產(chǎn)品標準后，方可用于臨床試驗或者申請注冊。Article 9 Class

19、 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 apply for registration. 經(jīng)國家食品藥品監(jiān)督管理局會同國家質(zhì)量監(jiān)督檢驗檢疫總局認可的醫(yī)療器械檢測

20、機構(gòu)（以下簡稱醫(yī)療器械檢測機構(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 following) shall be issued at another time. 第十條醫(yī)療器械檢測機構(gòu)應(yīng)當在國家食品

21、藥品監(jiān)督管理局和國家質(zhì)量監(jiān)督檢驗檢疫總局認可的檢測范圍內(nèi)，依據(jù)生產(chǎn)企業(yè)申報適用的產(chǎn)品標準（包括適用的國家標準、行業(yè)標準或者生產(chǎn)企業(yè)制定的注冊產(chǎn)品標準）對申報產(chǎn)品進行注冊檢測，并出具檢測報告。Article 10 Medical device testing organization should do registration testing on applicant products according to available product standard including state standard, industry standard or registration produ

22、ct 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)療器械檢測機構(gòu)授檢范圍的醫(yī)療器械，由相應(yīng)的注冊審批部門指定有承檢能力的檢測單位進行檢測。For the medical device that have not been listed in testing range o

23、f all medical device testing organization should be tested by qualified testing united approbated by registration inspection department. 境外醫(yī)療器械的注冊檢測執(zhí)行境外醫(yī)療器械注冊檢測規(guī)定。Imported medical device registration shall perform “Imported Medical Device Registration Testing Regulation”.第十一條同一注冊單元內(nèi)所檢測的產(chǎn)品應(yīng)當是能夠代表本注冊單

24、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，重新注冊時，對產(chǎn)品的生物學評價可以不再進行生物相容性試驗。For re-registration the same kind products which made of same materia

25、l 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)通過生物學評價的原材料生產(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風險，申請注冊時，對產(chǎn)品的生物學評價可以不再進行生物相容性試驗。When register the products w

26、hich 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 compatibility during biological evaluation. 第十三條申請第二類、第三類醫(yī)療器械注冊，

27、同時滿足以下條件的，可以免予注冊檢測：Applying for Class II and Class III medical device registration will be exempted of doing registration testing if satisfy the following conditions:（一）所申請注冊的醫(yī)療器械與本企業(yè)已經(jīng)獲準注冊的醫(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 medical device and applied medical device is same in the basic pr

28、inciple, 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)條件審查機構(gòu)認可的檢測報告；The manufacturers have passed the medical device manufacturing quality administration regulation testing or get approval of medical device quality system certification

29、, meanwhile the manufacturers can provide the admissive testing report by inspection institution under former manufacturing condition. （三）所申請注冊的醫(yī)療器械與本企業(yè)已經(jīng)獲準注冊并且已經(jīng)通過注冊檢測的同類產(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)通過了醫(yī)療器械檢測機構(gòu)檢測；Comparing with approved registration medical de

30、vices , 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 institution. （四）已經(jīng)獲準注冊的本企業(yè)同類產(chǎn)品按照規(guī)定進行醫(yī)療器械不良事件監(jiān)測，并且未發(fā)現(xiàn)嚴重不良事件；The same

31、kind of approved registration medical devices have not been found adverse events in the process of MDR.（五）已經(jīng)獲準注冊的本企業(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 records in the process of product quality selective examination

32、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。Overseas medical devices have got pre-market approval by overseas medical device supervision government. 第十四條申請第二類、第三類醫(yī)療器械產(chǎn)品重新注冊，同時滿足以下條件的，可以免予注冊檢測：Applying for Class II and Class III medical device re-registrati

33、on will be exempted of doing registration testing if satisfy the following conditions:（一）申請重新注冊的醫(yī)療器械與本企業(yè)已經(jīng)獲準注冊的醫(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 principle, main function, structure, material and intended use.（二

34、）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)條件審查機構(gòu)認可的檢測報告；The manufacturers have passed the medical device manufacturing quality administration regulation testing or get approval of medical device quality system certification, meanwhile the manufacturers can provide the admissive testing

35、 report by inspection institution under former manufacturing condition. （三）申請重新注冊的醫(yī)療器械與已經(jīng)通過注冊檢測的原注冊產(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)療器械檢測機構(gòu)檢測；Comparing with approved registration medical devices , the same kind of applying re-registration medical devices do no

36、t 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）申請重新注冊的醫(yī)療器械在原醫(yī)療器械注冊證書有效期內(nèi)按照規(guī)定進行醫(yī)療器械不良事件監(jiān)測，并且未發(fā)現(xiàn)不良事件；Applying for re-registration medical devices have not b

37、een found adverse events in the process of MDR within the expiration date of the former medical device certificate.（五）原注冊醫(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 records in the process of product quality selective examination b

38、y 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、對安裝場地有特殊要求、檢測困難的大型醫(yī)療器械，可以申請暫緩檢測，于取得醫(yī)療器械注冊證書后再對產(chǎn)品進行補充檢測。Huge medical equipments which have got pre-market notification by overseas medical device supervision department, need special requirements on spot installation an

39、d 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)定申請暫緩檢測而獲準注冊的產(chǎn)品，生產(chǎn)企業(yè)必須在首臺醫(yī)療器械入境后、投入使用前完成注冊檢測。經(jīng)檢測合格后方可投入使用。For the products satisfied with above regulation that get registration approval when applying for po

40、stpone 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Chapter 3 Medical device clinical trial 第十六條申請第二類、第三類醫(yī)療器械注冊，應(yīng)當提交臨床試驗資料。When applying for Class II and Class III med

41、ical devices registration, clinical trial material should be submitted.臨床試驗資料提供方式執(zhí)行醫(yī)療器械注冊臨床試驗資料分項規(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 Regulation.(Refer to attachment 12)第十七條 在中國境內(nèi)進行醫(yī)療器械臨床試驗的，應(yīng)當嚴格

42、執(zhí)行醫(yī)療器械臨床試驗規(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)進行臨床試驗的醫(yī)療器械，其臨床試驗資料中應(yīng)當包括臨床試驗合同、臨床試驗方案、臨床試驗報告。The clinical trial material of medical devices processed in China shall include clinical trail agreement, clinical trial project

43、and clinical trial report. （食品）藥品監(jiān)督管理部門認為必要時，可以要求生產(chǎn)企業(yè)提交臨床試驗須知、知情同意書以及臨床試驗原始記錄。Food drug supervision administration could ask manufacture to provide clinical trial memorandum, acknowledgment letter and clinical trial original records.第四章 醫(yī)療器械注冊申請與審批Chapter 4 Medical device registration application an

44、d inspection第十九條申請醫(yī)療器械注冊，申請人應(yīng)當根據(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，并應(yīng)當填寫醫(yī)療器械注冊申請表，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)要求提交申請材料。申請材料應(yīng)當使用中文；根據(jù)外文資料翻譯的申請材料，應(yīng)當同時提供原文。When applying for medical devices registration, applicants shall accord with the medical device classification and apply to concerning food drug

45、supervision administration according to item 4 of this methods.申請人提交的醫(yī)療器械說明書應(yīng)當符合醫(yī)療器械說明書、標簽和包裝標識管理規(guī)定。Medical device user manual submitted by applicants shall accord with Administration Regulation of Medical Device user manual, labeling and package '.申請人應(yīng)當對其申請材料全部內(nèi)容的真實性負責。Applicants shall take the

46、 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后，應(yīng)當根據(jù)下列情況分別作出處理：Food drug supervision administration shall treat respectively depending on the following conditions:（一）申請事項依法不屬于本部門職權(quán)范圍的，應(yīng)當即時作出不予受理的決定，并告知申請人向有關(guān)行政機關(guān)申請；If application articles legally do not belon

47、g to authorized scope of this department, should issue a rejection notice and advance applicants to apply for concerning administration unit. （二）申請材料存在可以當場更正的錯誤的，應(yīng)當允許申請人當場更正；If there is mistake in the application material that could be correct on-spot, the applicants shall be permitted to correct on

48、 spot. （三）申請材料不齊全或者不符合形式審查要求的，應(yīng)當當場或者在5個工作日內(nèi)發(fā)給申請人補正材料通知書，一次性告知申請人需要補正的全部內(nèi)容，逾期不告知的，自收到申請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 with Supplement Material Notice Letter within 5 workdays a

49、nd 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）申請材料齊全、符合形式審查要求的，或者申請人按照要求提交全部補正申請材料的，予以受理。It should be accepted if the application material is complete, acc

50、ord 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)療器械注冊申請，應(yīng)當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 accept medical devices application or not, an acceptance no

51、tice 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)療器械注冊申請后，應(yīng)當在本辦法第二十二條規(guī)定的期限內(nèi)對申請進行實質(zhì)性審查并作出是否給予注冊的書面決定。經(jīng)審查符合規(guī)定批準注冊的，自書面批準決定作出之日起10個工作日內(nèi)發(fā)給醫(yī)療器械注冊證書。經(jīng)審查不符合規(guī)定的，作出不予注冊的書面決定，并說明理由，同時告知申請人享有依法申請行政復(fù)議或者提起行政訴訟的權(quán)利。Food drug supervision administration shall

52、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 registration, medical device registration certificates

53、 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（食品）藥品監(jiān)督管理機構(gòu)應(yīng)當自受理申請之日起30個工作日內(nèi)，作出是否給予注冊的決定。 Food Drug regulatory authority of the government of the municipalities consisting of districts shall make a division whether to administer registration wi

54、thin 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)當自受理申請之日起60個工作日內(nèi)，作出是否給予注冊的決定。 Food Drug regulatory authorities of the provinces, autonomous regions and municipalities shall make a division whether to administer registration within 60 workdays form the date of application. 國家食品藥品

55、監(jiān)督管理局應(yīng)當自受理申請之日起90個工作日內(nèi)，作出是否給予注冊的決定。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. 在對注冊申請進行審查的過程中，需要檢測、專家評審和聽證的，所需時間不計算在本條規(guī)定的期限內(nèi)。（食品）藥品監(jiān)督管理部門應(yīng)當將所需時間書面告知申請人。In the process of i

56、nspection, 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. 第二十三條未獲得境外醫(yī)療器械上市許可的境外醫(yī)療器械，申請注冊時，參照境內(nèi)同類產(chǎn)品注冊的技術(shù)審查要求執(zhí)行（需要提交的材料見

57、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 material shall refer to attachment 8 and attachment 9). 第二十

58、四條（食品）藥品監(jiān)督管理部門在對醫(yī)療器械注冊申請材料進行技術(shù)審查時，需要生產(chǎn)企業(yè)補充材料的，應(yīng)當一次性發(fā)出書面補充材料通知。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 needed. 生產(chǎn)企業(yè)應(yīng)當在60個工作日內(nèi)按照通知要求將材料一次性補齊，補充材料的時間不計算在（食品）藥品監(jiān)督管理部門進行實質(zhì)審查的期限內(nèi)。生產(chǎn)企業(yè)未能在規(guī)定的時限內(nèi)補充材料且沒有正當理由的，終止審查。Manufacture shall submit all the requested supplementary material at one time a