进口医疗器械II、III类注册流程时?/strong>
上海：上海维坤商务咨询公司（负责上海及华东客户） (86)21-51087230-183\181
北京：北京迈迪克豪尔医药技术咨询服务有限公司（负责北京及华北客户） (86)10-63323201-8015
在此再三强调，以下任何原创文章的转载需得到维绅公司或北京迈迪克的授权，并注明出处！不得用于任何形式的商业用途！一经发现侵权，本公司将保留运用法律手段维护自身的权利?/p>
注册工作具体实施步骤?/span>II?/span>III类医疗器械）
List of Registration Process and Needing Time (Class II & Class III Medical Device)
|
序号
Serial
|
工作内容
Content of Job
|
工作时间
Working Time
|
|
1
|
确定客户需求，并对产品进行分类?/span>
Confirm client’s requirement, classify products
|
6个月
|
|
2
|
双方经协商签定注册代理合同，并交?/span>60%代理费及其它相关费用?/span>
Signature agent contract, pay 60% agent fee
|
|
|
3
|
客户在我司指导下准备技术资料及政府文件?/span>
Help client prepare registration documents
|
10~20?/span>
10~20 days
|
|
4
|
资料齐全后，双方签订《委托翻译合同》，CRCS对外文资料进行翻译?/span>
Translate all documents to Chinese
|
2~3?/span>
2~3 weeks
|
|
5
|
制订注册产品标准?/span>
Draw the technical standard according Chinese Nation standard
|
1~2?/span>
1~2 weeks
|
|
6
|
根据SFDA规定到指定的检测机构进行产品检测，并获得有效检测报?/span>
Send sample to SFDA test center for test and obtain the test report.
|
60个工作日*
60 working days
|
|
7
|
整理资料报送国家药监局受理中心并取得受理通知书?/span>
Reorganize all documents and send to SFDA, acquire SFDA?notice of accepting
|
5个工作日
5 working days
|
|
8
|
国家药监局对注册产品资料进行评审?/span>
Censor the registration documents in SFDA
|
序号
No.
|
部门
Department
|
受理内容
Content of acceptance
|
工作?/span>
Working day
|
|
1
|
受理?/span>
Acceptance Office
|
录入
Type the information.
|
2
|
|
2
|
转交技术审评中?/span>
Deliver to Center for Technology Evaluation and Testing.
|
3
|
|
3
|
技术审评中?/span>
Center for Technology Evaluation and Testing
|
主审人技术审?/span>
Technology Evaluation of Chief Umpire
|
36
|
|
4
|
复审人技术复?/span>
Technology Rehearing
|
5
|
|
5
|
中心主任签发
Director of Center signs.
|
5
|
|
6
|
行政审批
Approval in Administration
|
医疗器械司注册处经办人复?/span>
Transactor of Division of Product Registration of Medical Device Department checks.
|
7
|
|
7
|
医疗器械司注册处处长复核
Chief of Division of Product Registration of Medical Device Department checks.
|
7
|
|
8
|
医疗器械司司长复?/span>
Chief of Department of Medical Devices checks.
|
8
|
|
9
|
国家食品药品监管局局长复?/span>
Chief of SFDA checks.
|
8
|
|
10
|
转交医疗器械司注册处
Deliver to Division of Product Registration of Medical Device Department.
|
2
|
|
11
|
医疗器械司注册处
Division of Product Registration of Medical Device Department
|
转交受理?/span>
Deliver to Acceptance Office
|
2
|
|
12
|
受理?/span>
Acceptance Office
|
受理办发?/font>补充材料通知?/span>?/font>，并接收补充材料，转交技术审评中?/span>
Acceptance Office issues “Notice of documentation complementarity? and takes over the complementary documentation, and then delivers to Center for Technology Evaluation and Testing.
|
2
|
|
13
|
打印注册证、盖章、发布批件工?/span>
Print the registration, stamp on it, and issue the registration.
|
6
|
|
90个工作日*
90 working days
（此时间完全?/span>SFDA掌控，大?/span>7-10个月?/span>
|
|
9
|
取得注册证并以快递方式送交客户?/span>
Acquire the certification of registration and send to client
|
3~5个工作日
3~5working days
|
|
10
|
总时效：至少18个月
Total time: at least 18 Months
|
注：1、“工作日*”指国家法定工作?/span>
2、以上工作时限不包括申请人准备资料以及审评机构对资料有疑义需要补充资料及其它情况所用的费用?/span>
3、以上时限不包括实施临床试验时间，临床试验时间为：半?/span>~1?/span>
Note: 1. “Working day *?is national legal working day.
2. It doesn’t include the time that proposer prepares documents and SFDA has unbelief for registration documents and it needs to supply documents and so on.
3. The above time doesn’t include the time of clinical trial, and the time of clinical trial is 0.5 year ~ 1 year.