2016. volume 5 china food and drug newsletter · 2016. 4. 15. · and formulation of national...

Published byChina Center for Food and Drug International Exchange & Servier (Tianjin) Pharmaceutical Co., Ltd.

CHINA FOOD AND DRUG NEWSLETTER

施维雅(天津）制药有限公司

国家食品药品监督管理总局开展强制性标准整合精简工作

国家食品药品监督管理总局发布《关于药物临床试验数据自查核查注册申请情况的公告》

CFDA Launched Streamlining & Integration of Compulsory Standards

CFDA Issued Announcement on Registration Application Situation and Self-Examination & Verification of Drug Clinical Trial Data

To implement the requirements set forth in the Notice of the State Council on the Issuance of the Program for Deepening Standardization Reform (State Council [2015] No.13), and Notice of the State Council on the Issuance of the Program for Streamlining & Integration of Compulsory Standards (State Council General Office [2016] No. 3), recently, CFDA deployed and implemented the streamlining & integration of relevant compulsory standards.

The scope of streamlining & integration covers 95 compulsory national standards and 32 programs for development, revision and formulation of national medical device standards; 385 compulsory industry standards and 79 programs for development, revision and formulation of medical

On April 1, 2016, China Food and Drug Administrat ion (hereinafter referred to as CFDA) issued Announcement on Registration Application Situation and Self-Examination & Verification of Drug Clinical Trial Data ([2016] No. 81), which reads as follows:

After the release of Announcement on Performing Self-Examination & Verification of Drug Clinical Trial Data (CFDA Announcement No. 117, 2015) on July 22, 2015, CFDA has received new registration applications for production or import of

device industry standards; 10 compulsory national standards for cosmetics, and 13 programs for development, revision and formulation of cosmetics industry standards. By "repealing, converting, integrating and revising" a number of standards, these measures aim to solve the major problems of overlapping, redundant or contradictory compulsory standards; research and establish a reasonable and scientific compulsory standard system framework, to ensure the essential and strategic role of standards in promoting the governance system and governance modernization under the premise of not causing regulatory vacuum, and maintaining the bottom line for food and drug safety. (April 5, 2016)

256 post-clinical-trial drugs; as of April 1, 2016, 75 registration applications have been voluntarily withdrawn, and CFDA has decided to perform stepwise clinical trial data verification for the remaining 181 registration applications (see Annex). The related matters are announced as follows:

I. If the drug registration applicants find inauthenticity of clinical trial data before the verification, they shall take the initiative to apply for withdrawal of registration application, CFDA will announce the list of

为贯彻落实《国务院关于印发深化标准化

工作改革方案的通知》（国发〔2015〕13号）

和《国务院办公厅关于印发强制性标准整合精

简工作方案的通知》（国办发〔2016〕3号）

的要求，近期，国家食品药品监管总局部署开

展了相关强制性标准整合精简工作。

整合精简范围包括医疗器械强制性国家

标准95项，制修订计划32项；强制性行业标准

385项，制修订计划79项。化妆品强制性国家

标准10项，制修订计划13项。通过“废止一

批、转化一批、整合一批、修订一批”的方

式，解决强制性标准存在的交叉重复矛盾等主

要问题，同时研究提出科学合理的强制性标准

体系框架，确保在不造成监管真空、不降低安

全底线的前提下，更好地发挥标准在推进治理

体系和治理能力现代化中的基础性、战略性作

用。（2016-04-05）

2016年4月1日，国家食品药品监督管理总

局发布《关于药物临床试验数据自查核查注册

申请情况的公告》（2016年第81号）。内容如

下：

2015年7月22日《关于开展药物临床试验

数据自查核查工作的公告》（国家食品药品

监督管理总局公告2015年第117号）发布后，

国家食品药品监督管理总局（以下简称“总

局”）新收到256个已完成临床试验申报生产

或进口的药品注册申请，截止到2016年4月1日，药品注册申请人已主动撤回其中的75个注册申请，总局决定对剩余的181个注册申请

（见附件）逐一进行药物临床试验数据核查。

有关事宜公告如下：

2016. Volume5

2 CHINA FOOD AND DRUG NEWSLETTER

CFDA Issued Work Procedures for Drug Clinical Trial Data Verification (Interim)

一、在总局组织核查前，药品注册申

请人自查发现药物临床试验数据存在真实

性问题的，应主动撤回注册申请，总局公

布名单，不予追究责任。

二、总局食品药品审核查验中心将在

其网站公示现场核查计划，并告知药品注

册申请人及其所在地省级食品药品监管部

门，公示10个工作日后食品药品审核查验

中心将通知现场核查日期，不再接受药品

注册申请人的撤回申请。

三、总局将对药物临床试验数据现场

核查中发现数据造假的申请人、药物临床

试验责任人和管理人、合同研究组织责任

人从重处理，并追究未能有效履职的省级

食品药品监管部门核查人员的责任。（2016-04-01）

国家食品药品监督管理总局印发《药物临床试验数据核查工作程序（暂行）》

2016年3月28日，国家食品药品监督管

理总局发布《关于印发药物临床试验数据

核查工作程序（暂行）的通知》，全文如

下：

各省、自治区、直辖市食品药品监督

管理局，总局药审中心、核查中心：

为加强药物临床试验数据核查工作

组织管理，保障药物临床试验数据核查质

量和效率，现将《国家食品药品监督管理

总局药物临床试验数据核查工作程序（暂

行）》印发给你们，请遵照执行。

国家食品药品监督管理总局药物临

床试验数据核查工作程序（暂行）

第一条　为保障药物临床试验数据核

查质量和效率，加强核查工作组织管理，

On March 28, 2016, CFDA issued the Work Procedures for Drug Clinical Trial Data Verification (Interim), the full text of which is reproduced below:

Food and drug administration departments of all provinces, autonomous regions and municipalities directly under the central government , CFDA Center for Drug

Evaluation, Center for Food and Drug Inspection:

To r e i n f o r c e t h e o rg a n i z a t i o n a n d management of drug clinical trial data verification, and guarantee its quality and efficiency, the CFDA Work Procedures for Drug Clinical Trial Data Verification (Interim) are hereby issued for strict implementation accordingly.

CFDA Work Procedures for Drug Clinical Trial Data Verification (Interim)

Article 1 The Work Procedures for Drug Clinical Trial Data Verification (Interim)

国家食品药品监督管理总局发布批准上市药品公告

2016年4月7日，国家食品药品监督

管理总局发布《总局批准上市药品公告

（2016年第84号）》，内容如下：

2016年3月份共批准药品上市申请27件，其中，国产化学药品23件；进口化学

药品4件。（2016-04-07）

applicants and varieties withdrawn without affixing accountability.

II. Center for Food and Drug Inspection of CFDA shall publicize on its website the on-site verification plan, and inform the applicants and the competent provincial food and drug administration departments. Center for Food and Drug Inspection will inform relevant personnel of on-site verification date after the public notification for 10 days and no longer accept the application for withdrawal of any drug registration.

III . CFDA shall severely punish the appl icants , responsible persons and

On Apri l 7 , 2016, CFDA issued the Announcement on CFDA-approved Drugs for Marketing (2016 No. 84), which reads as follows:

managers of drug clinical trials and CROs found with frauds in clinical trial data on-site verification, and shall hold responsible the inspectors of provincial food and drug administration departments who failed to perform their duties.

(April 1, 2016)

In March 2016, CFDA has approved 27 applications for drugs, wherein there are 23 for domestic chemicals, and 4 for imported chemicals.

(April 7, 2016)

CFDA Issued Announcement on CFDA-approved Drugs for Marketing

Volume V 2016 3

制定本工作程序。国家食品药品监督管理

总局组织的药物临床试验数据现场核查的

通知、实施以及核查后的处理按照本工作

程序开展。

第二条　国家食品药品监督管理总

局药品审评中心（以下简称药审中心）与

国家食品药品监督管理总局食品药品审核

查验中心（以下简称核查中心）建立审评

需要核查品种沟通协调机制。药审中心根

据审评进度和评价需要，向核查中心提供

需要核查的品种情况。核查中心按审评顺

序、自查报告筛选以及举报信息等情况拟

定现场核查计划。

第三条　核查中心应将现场核查计

划在其网站公示10个工作日，注明联系方

式与反馈时限要求，并告知药品注册申请

人，同时告知其所在地省级食品药品监管

部门。

第四条　药品注册申请人在公示后10个工作日内未提出撤回申请的视为接受现

场核查。网上公示期结束后，对于未提出

撤回申请的品种，核查中心将通知药品注

册申请人、临床试验机构及其所在地省级

食品药品监管部门现场核查日期，不再接

受药品注册申请人的撤回申请。

第五条　检查组应按照《药物临床试

验数据现场核查要点》（国家食品药品监

督管理总局公告2015年第228号）内容开

展现场核查；核查记录应具体、准确、量

化，对影响对药物安全性、有效性评价数

据进行真实性、完整性判断的，应依法取

证。

第六条　核查中心在现场核查结束后

10个工作日内形成核查意见，并在形成核

查意见后向药品注册申请人和主要研究者

反馈和沟通核查情况。

第七条　核查中心将明确的核查意见

转药审中心进行综合审评，药审中心对现

场核查存在数据不真实、不完整问题，影

响药品安全性、有效性评价的，应在收到

核查意见后5个工作日内形成综合意见，连

同有关资料报国家食品药品监督管理总局

药品化妆品注册管理司。

第八条　国家食品药品监督管理总局

作出审批决定后，对现场核查发现问题而

不予批准的药品注册申请相关情况予以公

告。对涉嫌弄虚作假的立案调查。

（2016-03-29）

(hereinafter referred to as the Procedures) are formulated to guarantee the quality and efficiency, and strengthen the organization and management of drug clinical trial data verification. The Procedures apply to the notification, implementation and post-verification protocols for CFDA-organized on-site verification of drug clinical trial data.

A r t i c l e 2 C F D A C e n t e r f o r D r u g Evaluation (hereinafter referred to as CDE) and CFDA Center for Food and Drug Inspection shall establish communication and coordination mechanism for varieties under review. CDE shall provide the varieties information to center for Food and Drug Inspection in accordance with the progress and needs of the review and evaluation. Center for Food and Drug Inspection shall prepare on-site verification program according to review sequence, screening of self-inspection, and information of complaints and reports, etc.

Article 3 Center for Food and Drug Inspection shall publicize on its website the on-site verification plan for 10 working days, indicating the contacts, feedback deadlines and other requirements, and inform the applicants of drug registration as well as the competent provincial food and drug administration departments.

Article 4 Drug registration applicants who did not withdraw the applications within 10 working days after the public notification shall be regarded as accepting the on-site verification. After completion of online publicity, for applications have not been withdrawn, Center for Food and Drug Inspection shall notify the on-

site verification date to applicants of drug registration, clinical trials institutions and the provincial food and drug administration departments, and no longer accept the application for withdrawal of any drug registration.

Article 5 The inspection team shall perform on-site verification as per the Key Points for On-Site Verification of Drug Clinical Trial Data (CFDA Announcement No. 228, 2015); the verification records should be specific, accurate and quantifiable, and evidence should be collected according to the law for evaluation data influencing the authenticity & integrity judgment of drug safety and efficacy.

Article 6 Center for Food and Drug Inspection shall reach a verif ication conclusion within 10 working days after the on-site verification, and feedback and communicate the corresponding information to drug registration applicants and principal investigators.

Article 7 Center for Food and Drug I n s p e c t i o n s h a l l c o n v e y t h e c l e a r verification opinions to CDE for the comprehensive review, CDE shall reach a comprehensive conclusion on untrue, incomplete problems in on-site verification that can affect drug safety and efficacy evaluation within 5 working days upon receipt of the verification opinions, and report them together with the relevant materials to CFDA Department of Drug and Cosmetics Registration.

Article 8 Once the approval is issued, CFDA shall release public announcement of the relevant information of drug registration applications disapproved on account of the on-site verification problems. Suspected frauds shall be subject to investigation.

(March 29, 2016)


国家食品药品监督管理总局办公厅发布关于贯彻实施《医疗器械临床试验质量管理规范》的通知

国家食品药品监督管理总局发布批准注册医疗器械产品公告

国家食品药品监督管理总局发布实施《医疗器械通用名称命名规则》有关事项的通知

CFDA General Office Issued the Notice on Implementing the Good Clinical Practice for Medical Devices

CFDA Issued Announcement on Medical Device Products Approved for Registration

CFDA Issued Notice on Issues Pertaining to the Implementation of the Nomenclature for Common Names of Medical Devices

《医疗器械临床试验质量管理规范》

（国家食品药品监督管理总局令第25号，

以下简称《规范》）将于2016年6月1日施

行。为做好贯彻实施工作，2016年4月7日，国家食品药品监督管理总局办公厅发

布关于贯彻实施《医疗器械临床试验质量

管理规范》的通知，要求各省、自治区、

直辖市食品药品监督管理局要充分认识实

施《规范》的重要意义；大力开展《规

范》宣传贯彻和培训；加强临床试验日常

监督检查。（2016-04-07）

2016年4月1日，国家食品药品监督

管理总局发布《总局关于批准注册医疗器

械产品公告（2016年第82号）》，内容如

下：

2016年1—2月，国家食品药品监督管

理总局共批准注册医疗器械产品471个。其

中，境内第三类医疗器械产品186个，进口

第三类医疗器械产品165个，进口第二类医

疗器械产品120个。　　（2016-04-06）

《医疗器械通用名称命名规则》（国

家食品药品监督管理总局令第19号）（以

下简称《命名规则》）已发布，自2016年4月1日起施行。为做好《命名规则》实施工

作，2016年3月30日，国家食品药品监督管

理总局发布《关于实施〈医疗器械通用名

称命名规则〉有关事项的通知》，就有关

事项进行通知。

通知要求，各自治区、直辖市食品药

品监督管理局，有关单位要切实提高对医

疗器械命名工作重要性的认识、大力做好

The Good Clinical Practice for Medical Devices (CFDA Order No. 25, hereinafter referred to as GCP) will be implemented as f rom June 1, 2016. For effect ive implementation of the GCP, on April 7, 2016, CFDA General Office issued the Notice on Implementing the Good Clinical Practice for Medical Devices, requiring food and drug administration departments of all provinces, autonomous regions and municipalities directly under the central government to fully understand

On Apri l 1 , 2016, CFDA issued the Announcement on Medical Device Products

The Nomenclature for Common Names of Medical Devices (CFDA Order No. 19) (hereinafter referred to as the Nomenclature) has been promulgated and implemented as from April 1, 2016. For effective implementation of the Nomenclature, CFDA issued on March 30, 2016 the Notice on Issues Pertaining to the Implementation of the Nomenclature for Common Names of Medical Devices (the Notice), and the relevant matters are hereby notified as follows.

the importance of GCP implementation; vigorously carry out the publicity and training of GCP; and strengthen the daily supervision and monitoring of clinical trials. (April 7, 2016)

Approved for Registration (2016 No. 82), which reads as follows:

From January to February, 2016, CFDA has approved the registration for a total of 471 medical devices. Among them, there are 186 domestic Class III medical devices, 165 Class III imported medical devices , and 120 Class I I impor ted medical devices.

(April 6, 2016)

The Notice requires the food and drug administration departments and relevant units of al l autonomous regions and municipalities directly under the central government to effectively raise awareness of the importance of the Nomenclature; v i g o r o u s p e r f o r m t h e p u b l i c i z i n g , implementa t ion and t ra in ing of the Nomenclature; and the Notice specifies that: For medical device registration applications accepted after April 1, 2016, the registration applicant shall prepare product names in

医疗器械Medical Devices

Volume V 2016 5

CFDA Issued Six Normative Documents Including the Template of Application & Approval Form for Ethical Review of Medical Device Clinical Trials

国家食品药品监督管理总局、国家卫生计生委联合发布《医疗器械临床试验质量管理规范》

国家食品药品监督管理总局发布《医疗器械临床试验伦理审查申请与审批表范本》等六个文件

CFDA & NHFPC Jointly Issued the Good Clinical Practice for Medical Devices

为进一步加强医疗器械临床试验监

督管理，2016年3月23日，国家食品药品

监督管理总局、国家卫生和计划生育委员

会联合发布《医疗器械临床试验质量管理

规范》（食品药品监管总局令第25号）。

《规范》共11章96条，包括总则、临床试

验前准备、受试者权益保障、临床试验方

案、伦理委员会职责、申办者职责、临床

试验机构和研究者职责、记录与报告、

试验用医疗器械管理、基本文件管理、附

则。《规范》将于2016年6月1日起施行。

　　（2016-03-23）

为进一步规范医疗器械临床试验过

程，加强医疗器械临床试验管理，根据

《医疗器械临床试验质量管理规范》，国

家食品药品监督管理总局组织制定了《医

疗器械临床试验伦理审查申请与审批表范

本》《知情同意书范本》《医疗器械临床

试验病例报告表范本》《医疗器械临床试

验方案范本》《医疗器械临床试验报告范

本》《医疗器械临床试验应当保存的基本

文件目录》六个文件，于2016年3月23日发布，与《医疗器械临床试验质量管理规

范》同步实施。　　（2016-03-23）

To further strengthen the supervision and management of medical device clinical trials, on March 23, 2016, China Food and Drug Administration (CFDA) and National Health and Family Planning Commission of China (NHFPC) recently jointly issued the Good Clinical Practice for medical devices (CFDA Order No. 25), which comprises 96 articles in 11 chapters, including general provisions, preparation before clinical trials, protection of rights and benefits of trial subjects,

To further standardize and strengthen the management of medical device clinical trial process, according to the Good Clinical Practice for Medical Devices , CFDA organized the formulation of six normative documents: Template of Application &

clinical trial protocol, responsibilities of ethics committee, responsibilities of sponsors, responsibilities of clinical trial institutions and investigators, record and report, management of investigational medical devices, management of essential documents, and supplementary provisions. The Good Clinical Practice for Medical Devices will be implemented as of June 1, 2016.

(March 23, 2016)

Approval Form for Ethical Review of Medical Device Clinical Trials, Template of Informed Consent, Template of Medical Device Clinical Trials Case Report Form, Template of Medical Device Clinical Trial Protocol, Template of Medical Device Clinical Trial Reports, and Catalogue of Essential Documents to Be Filed for Medical Device Clinical Trials, Which have been released on March 23, 2016, and shall be implemented simultaneously with the Good Clinical Practice for Medical Devices. (March 23, 2016)

《命名规则》宣传贯彻和培训工作，并且

明确自2016年4月1日起受理的医疗器械

注册申请，注册申请人应当按照《命名规

则》拟定产品名称，医疗器械技术审评机

构应当对产品名称予以审核规范。在2016年4月1日前已受理尚处于技术审评环节的

医疗器械注册申请，医疗器械技术审评机

构也应当对产品名称予以审核规范；在

2016年4月1日前已获准注册的医疗器械，

其产品名称可在注册证有效期内继续使

用；自2016年4月1日起，办理第一类医疗

器械备案的产品，备案人应当按照《命名

规则》及备案的相关规定确定产品名称。

（2016-03-30）

accordance with the Nomenclature, and medical device evaluation institutions should perform review and regulation of the product names. For medical device registration applications accepted before April 1, 2016, and are still undergoing the technical review, medical device evaluation

institutions should also perform review and regulation of the product names. For medical devices already approved for registration before April 1, 2016, their product names may continue to be used in the valid periods of registration certificates. (March 30, 2016)


国家食品药品监督管理总局发布普通口服固体制剂参比制剂选择和确定等3个技术指导原则

国家食品药品监督管理总局发布2015年度医疗器械注册工作报告

CFDA Issued Three Technical Guidelines Including the Selection and Determination of Reference Formulation for Ordinary Oral Dosage Forms

CFDA Issued 2015 Annual Report for Medical Device Registration

为规范仿制药质量和疗效一致性评价

工作，国家食品药品监督管理总局组织制

定了《普通口服固体制剂参比制剂选择和

确定指导原则》、《普通口服固体制剂溶

出曲线测定与比较指导原则》和《以药动

学参数为终点评价指标的化学药物仿制药

人体生物等效性研究技术指导原则》，于

2016年3月15日发布。

（2016-03-18）

2016年4月1日，国家食品药品监督管

理总局发布2015年度医疗器械注册工作报

告，部分内容转载如下：

2015年度医疗器械注册工作报告

2015年，国家食品药品监督管理总局

（以下简称食品药品监管总局）以维护和

促进公众健康为己任，深入贯彻落实《医

疗器械监督管理条例》（国务院令第650号）和《国务院关于改革药品医疗器械审

评审批制度的意见》（国发〔2015〕44号），推进医疗器械审评审批制度改革，

规范和指导全国医疗器械注册工作，提升

医疗器械注册审评质量与效率。

一、医疗器械注册工作情况

依据《医疗器械监督管理条例》 ,食品药品监管总局负责境内第三类和进口第

二、三类医疗器械注册受理、技术审评和

行政审批工作。省级食品药品监督管理部

门负责境内第二类医疗器械注册受理、技

术审评和行政审批工作。

（一）完善医疗器械注册管理法规体系

制定发布了《医疗器械分类规则》

《医疗器械通用名称命名规则》《医疗器

械临床评价技术指导原则》《境内第三

类医疗器械注册质量管理体系核查工作程

序》等16个规章及规范性文件。进一步完

善了医疗器械注册管理法规体系，规范

了医疗器械技术审查、注册核查等相关工

To regulate the quality and efficacy of generic drugs conformance assessment, CFDA formulated the Technical Guidelines for Se lec t ion and Determinat ion o f Reference Formulation for Ordinary Oral Dosage Forms, Technical Guidelines for Measurement and Comparison of Dissolution Profile of Oral Dosage Forms, and Technical Guidelines for Human Bioequivalence Study of Chemical Generics

On April 1, 2016, China Food and Drug Administration issued 2015 Annual Report for Medical Device Registration, excerpts of the report are as follows:

2015 Annual Report for Medical Device Registration of CFDA

I n 2 0 1 5 , C h i n a F o o d a n d D r u g Administration (hereinafter referred to as CFDA) took maintaining and promoting public health as i ts duty, thoroughly implemented Regulations for the Supervision and Administration of Medical Devices (State Council Order No. 650) and Opinions of State Council on Reforming Drug and Medical Device Review and Approval System (GF [2015] No. 44), promoted the reform of medical device review and approval system, standardized and guided the medical device registration nationwide and improved the quality and efficiency of medical device registration review.

I. Registration of medical devices

Based on Regulations for the Supervision and Administration of Medical Devices, CFDA is responsible for the acceptance,

Taking Pharmacokinetic Parameters as Endpoints, which have been released on March 15, 2016. (March 18, 2016)

technical evaluation and administrative review and approval of the registration of domestic Class III and imported Class II and III medical devices. Provincial food and drug regulatory authorities are responsible for the acceptance, technical evaluation and administrative review and approval of the registration of domestic Class II medical devices.

(I)Improve the regulation system related to the management of medical device registration

CFDA developed and issued 16 rules and normative documents including Rules for Classification of Medical Devices, Naming Rules for Medical Device Generic Name, Technical Guidelines for Clinical Evaluation of Medical Devices, and Working Procedure for Verification of Quality Management System of Domestic Class III Medical Device Registration. CFDA further improved regulation system related to the management of medical device registration, and regulated relevant work including technical evaluation and registration verification of medical devices, providing a good legal basis for registration management of the food and drug regulatory authorities at all levels and orderly conducting of registration application by administrative counterparts.

Volume V 2016 7

作，为各级食品药品监管部门注册管理工

作和行政相对人注册申报工作的有序开展

提供了良好的法规基础。

（二）推进医疗器械审评审批制度改革

2015年，食品药品监管总局医疗器械技

术审评中心研究制定了审评机制改革实施方

案，进一步加强了审评员岗前培训和继续教

育培训工作，提升审评员综合素质。

食品药品监管总局审核发布了《有源

植入式医疗器械》等28项国家标准和《血

液透析及相关治疗用水》等90项行业标

准。制定了《医疗器械分类管理改革工作

方案》，成立医疗器械分类技术委员会，

启动《医疗器械分类目录》修订工作。继

续按照《创新医疗器械特别审批程序（试

行）》做好创新医疗器械审查工作，推动

医疗器械行业创新发展。

（三）开展省级医疗器械审评审批能力

考核评估

食品药品监管总局发布了《关于加强

省级医疗器械技术审评能力建设的指导意

见》，组织制定了《省级医疗器械审评审

批能力考核评估工作方案》，并组织开展

了省级医疗器械审评审批能力考核试点评

估工作，促进了省级食品药品监管部门注

册管理水平和质量的提升。

（四）加强注册基础工作建设

食品药品监管总局继续推动医疗器械

注册技术审查指导原则的制修订工作，共

发布“乙型肝炎病毒基因分型检测试剂”

等12个产品注册技术指导原则和“软性亲

水接触镜”等2项说明书编写指导原则。截

至2015年底共发布医疗器械注册技术审查

指导原则125项。通过指导原则的发布，进

一步统一了特定医疗器械注册在全国范围

内尺度，也为管理相对人办理注册申报提

供了有效指导。

2015年9月10日，食品药品监管总局上

线启用了医疗器械注册管理第一类备案子

系统，规范、指导了各地第一类医疗器械

备案工作。2015年12月20日，上线启用了

食品药品监管总局医疗器械注册管理新系

统，规范注册电子申报要求，提升审查工

作的信息化水平和工作效率。

二、医疗器械注册申请受理情况

2015年，食品药品监管总局共受理医

疗器械（体外诊断试剂）注册申请9396项，

其中，首次注册申请2402项，延续注册申

请5105项，许可事项变更申请1889项，同比

2014年相应注册受理项目减少6.7%。

（一）整体情况

(II) Promote the reform of review and approval System for medical devices

In 2015, Center for Medical Device Eva lua t ion of CFDA deve loped the implementation plan for the reform of review mechanism, and further strengthened pre-job training and continuing education and training to improve comprehensive quality of reviewers.

CFDA reviewed and issued 28 national standards including Active Implantable Medical Device and 90 industrial standards including Water for Hemodialysis and Related Therapies . CFDA developed Work Plan for the Reform of Classified M a n a g e m e n t o f M e d i c a l D e v i c e s , es tabl ished Technical Commit tee of Medical Device Classification and initiated the revision of Classification Catalogue for Medical Device. CFDA continued to carry out the review on innovative medical devices in accordance with Special Review and Approval Procedure for Innovative Medical Devices (Interim) to promote the development of innovation in medical device industry.

(III) Carry out assessment and evaluation of medical device review and approval capacity at provincial levels

CFDA i s sued Guid ing Opin ions on Strengthening the Construction of Provincial Technical Evaluation Capacity for Medical Devices, organized to develop Work Plan for Assessment and Evaluation of Provincial Medical Device Review and Approval Capacity, organized to carry out pilot evaluation of the assessment of provincial medical device review and approval capacity and promoted the improvement in the registration management level and quality of provincial food and drug regulatory authorities.

(IV) Strengthen the construction of basic work of registration

C F D A c o n t i n u e d t o p r o m o t e t h e development and revision of Technical Guideline for Registration of Medical Devices, and issued technical guidelines for the registration of 12 products including "Reagent for HBV Genotyping Assay " and

guidelines for the drafting of instructions for use for 2 products including "Soft (Hydrophilic) Contact Lens". By the end of 2015, a total of 125 technical guidelines for registration of medical devices has been issued. With the release of the guidelines, CFDA further unified the scale of the registration of specific medical device within the whole country, and also provided effective guidance for management counterpart handling registration application.

On September 10, 2015, CFDA enabled Class I Medical Device Filing Subsystem f o r M e d i c a l D e v i c e R e g i s t r a t i o n Management online, and standardized and guided the filing of Class I medical devices in all regions. On December 20, 2015, CFDA enabled a new Medical Device Registration Management System online, standardized the requirements for electronic application for registration, and promoted the informatization level and efficiency of review.

II. Acceptance of application for medical device registration

In 2015, CFDA accepted a total of 9396 registration applications for medical devices (in vitro diagnostic reagents), of which, there were 2402 applications for initial registration, 5105 applications for registration renewal, and 1889 applications for change of licensed items, showing a decrease of 6.7% in corresponding registration acceptance items comparing with those in 2014.

(I) Overall situation

In 2015, CFDA accepted 3921 registration applications for domestic Class III medical devices (in vitro diagnostic reagents) and 5475 registration applications for imported medical devices ( in vi tro diagnostic reagents).

In terms of varieties under application for registration, there were 5509 registration applications for medical devices and 3887 registration applications for in vitro diagnostic reagents.

In terms of registration categories, there were


2015年，受理境内第三类医疗器械

（体外诊断试剂）注册申请3921项，受理

进口医疗器械（体外诊断试剂）注册申请

5475项。

按注册品种区分，医疗器械注册申请

5509项，体外诊断试剂注册申请3887项。

按注册形式区分，首次注册申请2402项，延续注册申请5105项，许可事项变更

申请1889项。

（二）分项情况

1. 境内第三类医疗器械注册受理情况

2015年，境内第三类医疗器械注册

受理共3921项。其中，医疗器械注册申请

2219项，体外诊断试剂注册申请1702项。

从注册形式看，首次注册申请1562项，

占40%；延续注册申请1635项，占42%；许

可事项变更注册申请724项，占18%。

2. 进口第二类医疗器械注册受理情况

2015年，进口第二类医疗器械注册受

理共3024项。其中医疗器械注册申请1339项，体外诊断试剂注册申请1685项。



可事项变更注册申请，占20%。

3. 进口第三类医疗器械注册受理情况

2015年，进口第三类医疗器械注册受

理共2451项。其中医疗器械注册申请1951项，体外诊断试剂注册申请500项。



可事项变更注册申请535项，占22%。

综上，境内第三类体外诊断试剂首次

注册申请数量多于延续注册数量外，境内

第三类医疗器械、进口医疗器械和体外诊

断试剂均是延续注册申请数量多于首次注

册申请数量。而无论是境内第三类还是进

口医疗器械，其许可事项变更注册申请大

致相当，均为20%左右。

2402 applications for initial registration, 5105 applications for registration renewal and 1889 applications for change of licensed items.

have been accepted. Of which, there were 1339 registration applications for medical devices and 1685 registration applications for in vitro diagnostic reagents.

In terms of registration categories, there were 499 applications for initial registration, accounting for 17%; 1895 applications for registration renewal, accounting for 63%; and 630 registration applications for change of licensed items, accounting for 20%.

3. Acceptance of applications for imported Class III medical device registration

In 2015, a total of 2451 imported Class III medical device registration applications have been accepted. Of which, there were 1951 registration applications for medical devices and 500 registration applications for in vitro diagnostic reagents.


To sum up , there were more in i t ia l registration applications than registration renewal for domestic Class III in vitro diagnostic reagents while there were more registration renewal applications than initial registration for domestic Class III medical devices, imported medical devices and in vitro diagnostic reagents. However, no matter domestic Class III or imported medical devices, the numbers of registration applications for change of licensed items were approximately the same, about 20%.

图1. 注册形式比例图（注册申请受理）Figure 1. Proportion of registration categories (Acceptance of application)

图2. 境内第三类、进口第二类和第三类注册形式分布图Figure 2. Distribution of registration categories for domestic Class III, imported Class II and III medical devices

26%20%

54%

Initial registration

Registration renewal

Change of licensed items

(II) Situation of each category

1. Acceptance of applications for domestic Class III medical device registration

In 2015, a total of 3921 registration applications for domestic Class III medical devices have been accepted. Of which, there were 2219 registration applications for medical devices and 1702 registration applications for in vitro diagnostic reagents.


2. Acceptance of applications for imported Class II medical device registration

In 2015, a total of 3024 imported Class II medical device registration applications

720

1106

393

842

529

331

Ini�alregistra�on

Registra�onrenewal

Change of licenseditems

297

822

220202

1073

410







208

1342

401

133233

134

Volume V 2016 9

图3.2013—2015年度注册数据图Figure 3. Annual registration data in 2013-2015

图4. 2015年度国产和进口医疗器械注册数据图Figure 4. Registration data of imported and domestic medical devices in 2015

图5. 注册形式比例图（注册批准）Figure 5. Proportion of registration categories (Approved for registration)

图6. 境内第三类医疗器械和体外诊断试剂注册形式比例图Figure 6. Proportion of registration categories of domestic Class III medical devices and in vitro diagnostic reagents

三、医疗器械注册审评审批情况

（一）整体情况

2015年，食品药品监管总局共批准医

疗器械注册7530项。其中，首次注册2707项，延续注册4072项，许可事项变更注册

751项。与2013、2014年相比，注册批准总

数量略有下降。

2015年食品药品监管总局共对1297项医疗器械注册申请不予注册。

其中境内第三类医疗器械（含体外诊

断试剂）注册2730项，进口第二类、第三

类医疗器械（含体外诊断试剂）4800项。

按照注册品种区分，其中医疗器械

4823项，体外诊断试剂2707项，二者比例

约为6:4。按照注册形式区分，具体比例分

布见图5。（二）分项统计情况

1. 境内第三类医疗器械（体外诊断试剂）

境内第三类医疗器械首次注册334项，

延续注册1074项，许可事项变更注册86项。

境内第三类体外诊断试剂首次注册514项，延续注册479项，许可事项变更243项。

2. 进口医疗器械（体外诊断试剂）

进口医疗器械首次注册1533项，延续

注册1640项，许可事项变更注册156项。

进口体外诊断试剂首次注册326项，延

续注册879项，许可事项变更注册266项。

综上，从批准的产品整体情况看，延

续注册批准数量多于首次注册批准数量，

III. Review and approval for medical device registration

(I) Overall situation

In 2015, CFDA approved a total of 7530 medical device registration applications. Of which, there were 2707 applications for initial registration, 4072 applications for registration renewal and 751 registration applications for change of licensed items. Compared with those in 2013 and 2014, the total number of registration applications approved was slightly decreased.

I n 2 0 1 5 , C F D A m a d e t h e d e c i s i o n of disapproval for 1297 registrat ion applications for medical devices.

Of which, there were 2730 registration applications for domestic Class III medical devices (including in vitro diagnostic reagents) approved and 4800 registration applications for imported Class II and III medical devices (including in vitro diagnostic reagents) approved.

In terms of varieties under application for registration, there were 4823 registration applications for medical devices, and 2707 registration applications for in vitro diagnostic reagents, and the ratio is 6:4. In terms of registration categories, the specific ratio distribution is shown in the figure below.

(II) Statistics by categories

1. Domestic Class III medical devices (in vitro diagnostic reagents)

For domestic Class III medical devices, there were 334 applications for initial registration, 1074 applications for registration renewal and 86 registration applications for change of licensed items.

For domestic Class III in vitro diagnostic reagents, there were 514 applications for initial registration, 479 applications for registration renewal and 243 registration applications for change of licensed items.

2. Imported Medical Devices (In Vitro Diagnostic Reagents)

For imported medical device, there were 1533 applications for initial registration,

1640 applications for registration renewal and 156 registration applications for change of licensed items.

For imported in vitro diagnostic reagents, there were 326 applications for initial registration, 879 applications for registration renewal and 266 registration applications for change of licensed items.

To sum up, from the overall situation of approval, there were more applications for registration renewal approved compared with applications for initial registration. For domestic Class III in vitro diagnostic reagents, there were more applications

Renewal

Change

Initial72%6%

22%

Renewal

Change

Initial39%

20%

41%

Renewal

Change

Initial54%

10%

36%

2730

4800

Domes�c products Imported products

7875

8834

7530

2013 2014 2015


对于境内第三类体外诊断试剂，其首次注

册数量多于延续注册数量。

3. 具体批准品种种类分析

从首次和延续注册数据看，体外诊断试

剂在相应注册中产品比率占据明显优势。

其中，境内第三类医疗器械中，体外

诊断试剂注册数量占全部注册比率45%，进

口医疗器械中，体外诊断试剂比率达31%。

2015年，注册的境内第三类医疗器

械，除体外诊断试剂外，共涉及《医疗器

械分类目录》中26个子目录中产品。

注册数量前五位的境内第三类医疗器

械是：医用高分子材料及制品，植入材料

和人工器官,注射穿刺器械,医用光学器具、

仪器及内窥镜设备，介入器材。

2015年，注册的进口医疗器械，除体

外诊断试剂外，共涉及《医疗器械分类目

录》中41个子目录中产品。

注册数量前五位的进口医疗器械，主要

是：医用光学器具、仪器及内窥镜设备，植

入材料和人工器官，口腔科材料，医用电子

仪器设备，医用高分子材料及制品。

4. 进口医疗器械国别分析

2015年，美国、德国、日本、英国和

韩国医疗器械在中国医疗器械注册数量排

前五位，约占2015年进口产品首次、延续

注册总数量的67%。

5. 境内第三类医疗器械省份分析

从2015年境内第三类医疗器械注册情

况看，相关注册产品生产企业主要集中在

沿海经济较发达省份。

其中，北京、江苏、广东、上海、

山东是境内第三类医疗器械注册数量最多

的省份，占2015年境内第三类医疗器械首

次、延续注册数量的67%。

四、创新医疗器械等产品审评审批情

况（略）

五、其他信息

图7.进口医疗器械和体外诊断试剂注册形式比例图Figure 7. Proportion of registration categories of domestic imported medical devices and in vitro diagnostic reagents

图8. 境内第三类医疗器械注册品种排位图Figure 8. Ranking of registered varieties of domestic Class III medical devices

for initial registration approved than applications for registration renewal.

3. Analysis on the approved varieties

From the data of initial registration and registration renewal, in vitro diagnostic reagents were significantly superior in terms of the proportion in corresponding registration categories.

Among regis trat ion applicat ions for domestic Class III medical devices, the number of registration applications for in vitro diagnostic reagents approved accounted for 45% of all registration applications approved. Among registration applications for imported medical devices approved, it accounted for a proportion up to 31%.

In 2015, the domestic Class III medical devices that have been registered, except for in vitro diagnostic reagents, involve the products in 26 sub-catalogues in Classification Catalogue for Medical Device.

In terms of the number of registration applications approved, the top five domestic Class III medical devices were: medical polymer materials and products thereof, implanted materials and artificial organs, injection puncture instrument, medical opt ica l equipment , ins t ruments and endoscopic equipment, and interventional equipment.

In 2015, the imported medical devices that have been registered, except for in vitro diagnostic reagents, involve the products in

a total of 41 sub-catalogues in Classification Catalogue for Medical Device.

In terms of the number of registration applications approved, the top five imported medical devices were: medical optical equipment, instruments and endoscopic equipment, implant materials and artificial organs, dental materials, medical electronic instruments and equipment, and medical polymer materials and products.

4. Analysis on the countries of registered imported medical devices

In 2015, United States, Germany, Japan, United Kingdom and Korea ranked the top five in terms of the number of medical device registration applications approved in China, accounting for 67% of the total number of applications for initial registration and applications for registration renewal of imported products in 2015.

5. Analysis on the provinces of domestic Class III medical devices

From the registration applications of

Renewal

Change

Initial49%

5%

46%

Renewal

Change

Initial60%18%

22%

319

307

226

89

65

0 50 100 150 200 250 300 350

Medical polymer materials and products thereof

Implant materials and ar�ficial organs

Injec�on puncture instrument

Medical op�cal device, instrument andendoscope equipment

Interven�onal equipment

Volume V 2016 11

图9. 进口医疗器械注册品种排位图Figure 9. Ranking of registered varieties of imported medical devices

图10. 进口医疗器械国别注册排位图Figure 10. Ranking of the countries of registered imported medical devices

domestic Class III medical devices approved in 2015, the manufacturers of relevant registered products mainly located in the well-developed coastal provinces.

Of which, Beijing, Jiangsu, Guangdong, Shanghai and Shandong were top five provinces in terms of the number of registration applications for domestic Class III medical devices approved, accounting for 67% of the total number of applications for initial registration and applications for registration renewal of domestic Class III medical devices approved in 2015.

IV. Review and approval of innovative medical devices and other products

(Omitted)

V. Other information

(I) Registration of domestic Class II medical devices

In 2015, all provincial food and drug regulatory authorities has approved a total of 2284 registration applications for domestic Class II medical devices. Of which, there were 5566 applications for initial registration, 4918 applications for registration renewal and 1800 registration applications for change of licensed items.

Data of each province:

From the registration applications approved in provincial food and drug regulatory authorities, there were more domestic Class II medical devices registered in seven provinces (municipalities directly under the central government) including Guangdong, Jiangsu, Beijing, Zhejiang, Shanghai, Shandong and Henan.

(II) Filing of Class I Medical Device

In 2015, CFDA handled a total of 2488 filing applications for imported Class I medical devices in accordance with its responsibilities.

The food and drug regulatory authorities of the municipalities consisting of districts nationwide handled a total of 13516 filing applications for domestic Class I

（一）境内第二类医疗器械注册情况

2015年，各省级食品药品监管部门共

批准境内第二类医疗器械注册12284项。其

中首次注册5566项，延续注册4918项，许

可事项变更注册1800项。

（二）一类医疗器械备案情况

2015年，食品药品监管总局依职责共办

理进口第一类医疗器械备案数量2488项。

全国设区的市级食品药品监管部门共

依职责办理境内第一类医疗器械备案数量

13516项。

（三）登记事项变更情况

2015年，食品药品监管总局依职责共办

理进口第二、三类和境内第三类医疗器械登

记事项变更4691项。其中，境内第三类医疗

器械登记事项变更1590项，进口第二类、三

类医疗器械登记事项变更3101项。

全国各省级食品药品监管部门共依职

责办理境内第二类医疗器械登记事项变更

5255项。（2016-04-01）

medical devices in accordance with their responsibilities.

(III) Change to registered items

In 2015, CFDA handled a total of 4691 applications for change of registered items of imported Class II and III as well as domestic Class III medical devices in accordance with its responsibilities. Of which, there were 1590 applications for change of registered items of domestic Class III medical devices and 3101 applications for change of registered items of imported Class II and III medical devices.

All provincial food and drug regulatory authorities nationwide handled a total of 5255 applications for change of registered items of domestic Class II medical devices in accordance with their responsibilities.

(April 1, 2016)

474

448

298

238

200

0 100 200 300 400 500

Medical op�cal device, instrument andendoscope equipment

Implant materials and ar�ficial organs

Dental materials

Medical electronic instrument and equipment

Medical polymer materials and products

1324

799

401

217 178

0

200

400

600

800

1000

1200

1400

USA Germany apan England Korea


China Center for Food and Drug International Exchange (CCFDIE)中国食品药品国际交流中心

Address: Room 1106, 11th Floor, Office Building B, Maples International Center, No. 32, Xizhimen North Street, Haidian District, Beijing, 100082, P.R.C.

中国北京市海淀区西直门北大街32号枫蓝国际中心B座写字楼11层1106室邮编：100082

Tel: 010-8221 2866 Fax: 010-8221 2857Email: [email protected]: www.ccfdie.org

Servier (Tianjin) Pharmaceutical Co., Ltd.施维雅（天津）制药有限公司

Address: 6 Floor, West Building, World Financial Center, No.1, East 3rd Ring Middle Road, Chaoyang District, 100020 Beijing, China

北京市朝阳区东三环中路1号环球金融中心西楼6层邮政编码：100020

Tel: 010-6561 0341Fax: 010-6561 0348Website: www.servier.com.cn

Notes: • All Chinese information in the Newsletter is extracted from newspapers and the Internet. All English articles are translations from the Chinese version.

• For electronic version of the Newsletter please visit http://www.ccfdie.org 备注： • Newsletter中所有中文信息摘自报刊及网络。英文均系中文翻译。

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