[2019-09-02] 深圳市人民医院DSA(单C臂数字平板血管造影系统)采购招标公告
[2019-09-04] 关于深圳市人民医院DSA(单C臂数字平板血管造影系统)采购的补充公告

关于深圳市人民医院DSA(单C臂数字平板血管造影系统)采购的补充公告

发布日期:2019-09-04

 

各投标人:

关于《深圳市人民医院DSA(单C臂数字平板血管造影系统)采购》招标项目(招标编号:0658-19411A031283),由于招标公告中未体现资格要求,现补充如下:

资格证明文件和业绩:

1、投标人必须是来自中华人民共和国或是与中华人民共和国有正常贸易往来的国家或地区的法人或其他组织,并在中国国际招标网(www.chinabidding.com)注册成会员;(须提供营业执照或企业注册证明复印件)

2、国内投标人须为深圳市政府采购中心注册的供应商;(由招标机构在深圳市政府采购中心系统中查询,投标人无需提供证明材料)

3、参与本项目政府采购活动前三年内,在经营活动中没有重大违法记录;(必须按照招标文件格式IV-11. 声明函格式内容提供书面声明函)

4、参与本项目政府采购活动时不存在被有关部门禁止参与政府采购活动且在有效期内的情况;(必须按照招标文件格式IV-11. 声明函格式内容提供书面声明函)

5、若所投产品为进口,投标人必须提供由设备制造商或授权的中国总代理签署的合法有效的保修、维修承诺函。

6、若投标人为国内投标人且为所投产品的生产企业,必须提供《医疗器械生产企业许可证》或备案凭证,且生产范围包含该产品;若投标人为所投产品的代理商或授权供应商,必须提供《医疗器械经营企业许可证》或备案凭证,且经营范围包含该产品;当所投产品属于第一类医疗器械时无须提供《医疗器械经营企业许可证》或备案凭证,但投标人应在投标文件中对其所属类别进行书面说明;(提供复印件,原件备查)

7、投标人必须提供所投产品的《医疗器械注册(备案)证》的复印件,原件备查(开标时,该注册证应在有效期内;若不在有效期内,则需提供该注册证和所投产品在该注册证有效期内生产的药监局出具的证明文件)。

注:投标人必须到中国国际招标网注册(www.chinabidding.com)。


Qualifications and performance:

1. Bidders must be legal persons or other organizations from or countries or regions with which the People's Republic of China has normal trade, and shall be registered as members of the China International Tendering Network (www.chinabidding.com);

2. Domestic bidders must be registered suppliers of the Shenzhen Municipal Government Procurement Center; (inquiries by the bidding authority in the Shenzhen Municipal Government Procurement Center system, bidders do not need to provide supporting materials) 3. Within three years prior to participating in the government procurement activities of the project, there were no major illegal records in business activities;

The content of the statement letter form provides a written statement letter) 4. There is no case of participation in government procurement activities of the project that is prohibited by the relevant departments from participating in government procurement activities and is within the validity period; (must be in accordance with the tender document format IV-11.)

The content of the statement letter form provides a written statement letter)

5. If the product is imported, the bidder must provide a legal and valid warranty and repair commitment letter signed by the equipment manufacturer or authorized Chinese general agent. 6. If the bidder is a domestic bidder and the production enterprise of the product invested, it must provide the "Medical Device Manufacturing Enterprise License" or the documentation certificate, and the production scope includes the product;

And the scope of business includes the product, when the product is a category 1 medical device, it is not necessary to provide a "medical device operating enterprise license" or filing certificate, but the bidder should make a written statement on the category to which it belongs in the tender document; (provide a copy, the original for reference)

7. Bidders must provide a copy of the Medical Device Registration (Filing) Certificate of the product invested, the original is available for reference (when the tender is opened, the registration certificate shall be within the validity period; if not within the validity period, the registration certificate and the product signed by the FDA issued within the validity period of the registration certificate shall be provided).
Note: Bidders must register with China International Tender ingress (
www.chinabidding.com).


其他不变,特此通知。

                          

 

                      深圳市国际招标有限公司

二○一九年九月四日