Each district and city、Yang Ling Demonstration Area、Korean City、Shenmu City、Food and Drug Administration of Fuku County:
To regulate the logistics industry of the medical device in our province，Promoting the standardized development of medical device circulation，According to the "Regulations on the Supervision and Administration of Medical Devices"、"Measures for the Supervision and Management of Medical Device Management"、"Regulations on the Management of the Management Quality Management of Medical Devices" and other regulations，Our bureau has formulated "Shaanxi Provincial Medical Device Operation Enterprise to provide storage for other medical equipment production and operation enterprises、Measures for the Supervision and Management of Delivery Service (Trial)。The Bureau has been reviewed and approved，Now issued to you，Please follow the execution。
Shaanxi Food and Drug Administration
October 13, 2017
(Open attributes: active public)
Shaanxi Provincial Medical Devices Business Enterprises provide storage for other medical equipment production and operation enterprises、
Measures for the Supervision and Administration of Delivery Service (Trial)
Chapter 1 The first article
The first article According to the "Regulations on the Supervision and Administration of Medical Devices"、"Measures for the Supervision and Management of Medical Device Management"、"Regulations on the Management of the Management Quality Management of Medical Devices" and other regulations，In order to regulate the supervision and management of modern logistics storage and distribution of medical devices in Shaanxi Province，Ensure the quality management of medical device operation，Formation of these measures。
Article 2 This method refers to providing storage for other medical device production and operation enterprises、Delivery service enterprise (hereinafter referred to as medical equipment storage and distribution enterprises) refers to accepting the production of this provincial medical device、Business、Use unit or province to produce、The business enterprise entrusted it to provide it with medical device storage and distribution services for medical device operation enterprises。
Article 3 This method is applicable to medical device business enterprises that develop medical equipment storage and distribution stake sports betting appbusiness in Shaanxi Province。
Article 4 Shaanxi Provincial Food and Drug Administration (hereinafter referred to as the Provincial Food and Drug Administration) is responsible for the supervision and management of medical equipment storage and distribution services in the province，Credit rating assessment of storage and distribution companies，announcement to the society every year。
Article 5 Enterprise carried out medical equipment storage and distribution to follow the principle of voluntary application，The scale of the storage and distribution enterprise must be compatible with the storage and distribution conditions。
Chapter 2 Opening conditions
Article 6 Applying for medical device storage and distribution enterprises shall obtain the "Medical Device Business Business Enterprise License" and the second type of medical device business filing voucher，Compliance with the requirements of the "Management Specifications for the Management of Medical Devices"。and refer to the "Shaanxi Provincial Medical Device Operation Enterprise Provide Storage for other medical device production and operation enterprises、Technical Guide to Delivery Service Management "(hereinafter referred to as technical guide) is equipped with necessary equipment and facilities。
The storage and distribution enterprise's warehouse setting requirements are in the same building area，The warehouse is a dedicated area，No and self -employed products、Drugs (except for the in vitro diagnostic reagent of drug management)、Food and other products mixed，Subsequent increased warehouses (except for all stored products)，If you are not in the same building area, refer to the requirements of the "Ware and Equipment and Facilities" in the "Technical Guide" in the "Technical Guide"。
Article 7 Enterprises should have warehousing conditions and facilities My stake betting appthat are compatible with product storage and distribution requirements，The temperature of the normal temperature library is 0 ℃ ～ 30 ℃，When stored medical devices with special temperature and humidity requirements，It should also have a constant temperature that is compatible with its storage requirements and scale (15 ℃ ～ 25 ℃)、refrigerated library (2 ℃ ～ 8 ℃)、Frozen library (-25 ℃ ～ -15 ℃)。
Article 8 Medical equipment storage and distribution enterprises shall be in accordance with the requirements of the "Medical Device Business Quality Management Specifications"，Establish a medical device quality management system covering the entire process of logistics storage and distribution (refer to the relevant content requirements of the ISO13485 standard)，The system must include the quality management file of the commissioned medical device。
Article 9 Article 31，Enterprises should establish an independent computer information management platform，With the provincial food and drug supervision bureau and the commissioner to carry out real -time electronic data exchange and realize the entire process of product operation, it can be traced、Computer information platforms and technical means that can be tracked and managed。The computer information platform shall be at least by the warehouse management system (WMS)、Transport Management System (TMS) Composition，Cold Chain Transported Medical Device，Enterprise computer information stake sports betting appstake online sports bettingmanagement platform should also include the cold chain transport traceability system (CCTS)。The computer information management platform should be able to storage of medical equipment、Dynamic quality information implementation dynamic management and control，Cai can be collected for related data、Record、Query。
Chapter 3 Opening program
Article 10 For enterprises that have obtained the qualifications of medical device business, they plan to carry out the medical equipment storage and distribution business to apply for the business scope of the Food and Drug Administration in the local area，and refer to the "Technical Guide" for inspection and acceptance，You need to increase the warehouse to have the conditions for storage and distribution，Change the new warehouse to change，The Provincial Food and Drug Administration sent an observer to participate in the on -site acceptance，Observer collects the relevant information of the enterprise at the same time (see the content of the content of the content 1)，Used for follow -up related supervision。
Article 11 For enterprises that are applying for medical device business licenses, they intend to carry out medical equipment storage and distribution business at the same time，Food and Drug Supervision and Administration Bureau of each district and city can combine medical device business license and filing business，On -site inspections，At the same time, refer to the "Technical Guide" merged for one -time inspection and acceptance，The Provincial Food and Drug Administration sent an observer to participate in the on -site acceptance，Observer collects the relevant information of the enterprise at the same time (see the content of the content of the content 1)，Used for follow -up related supervision。
Article 12 Enterprises that meet the requirements for storage and distribution，The “medical device storage and transportation service” matters are increased by the local food and drug regulatory authorities in the local area and city in the “Medical Devices Business License” and medical device operation filing vouchers。
Article 13 Enterprises that obtain the business scope of medical equipment storage and distribution business, before January 31 the following year，The storage and distribution situation will be carried out in the previous year (see the information for the attachment 2) submitted to the Provincial Food and Drug Administration for archive for inspection。
Chapter 4 commission and entrustment
Article 14 The trustees who have obtained the qualifications of storage and distribution can only accept the production of the province、Business Enterprise、Use unit or province to produce、The commission of the product that operates the company and is within the scope of the trustee，The trustee shall not conduct a second commission (excluding commission transportation)。
Article 15 The client and the trustee should sign the "commission agreement"。The entrusted period agreed on the "commission agreement" shall be within the validity period of the trustee's operating license，Contains "product acceptance"、"Storage and Delivery Management"、"Tracing Management"、"Quality Responsibility" and other quality management agreed content，and "Entrusted Storage and Delivery Product Catalog"。
Article 16 The commissioner (that is, a medical device that needs to be entrusted to the storage and distribution business in the province) to choose to entrust all its medical equipment products to an enterprise with medical equipment storage and distribution qualifications，It is also regarded as "storage and distribution conditions My stake betting appthat stake betting appare compatible with the scope of business and business"，No warehouse，When applying for business permits or filing, it is necessary to provide an agreement to provide the qualifications for storing and distribution and signing。
Article 17 After the client should sign a commission agreement with the recipient's medical device storage and distribution service，Set up the database address change procedures to the district and municipal food and drug supervision bureau where it is located within 10 working days.，But the commission contract should be submitted)，After approval, the commissioner can only be confirmed by the medical equipment storage and distribution enterprise.，The medical equipment storage and distribution enterprise conducts medical equipment storage and distribution services for it。After the district and city food and drug supervision and administration bureau is set up after entrusted to the corporate warehouse change approval，At the same time, the approval results should be reported to the registered area of the Trust Enterprise.。Application for business enterprises to change the trustee or the new trustee，Changes according to the address of the library room。
Chapter 5 Quality Management and Responsibility
Article 18 Medical equipment storage and distribution enterprises shall conduct quality management in accordance with the requirements of the "Regulations on the Management of the Management of Medical Device Operations"。
Article 19 Trust enterprises shall accept commission of other enterprises in accordance with their capabilities and management capabilities，It must not exceed the storage and distribution that has the ability to carry out business。The trustee strictly follows the instructions of the medical equipment entrusted to the medical device、Label label requirements or special requirements of the agreement to carry out storage and distribution business。
Article 20 Accept the province、Autonomous Region、Entrusted by medical device manufacturers directly under the Central Government，The client must be agreed by the local provincial food and drug supervision and management department。
Article 21 The commissioner needs to be changed after the entrustment period、Cancel the entrustment object or continue to be entrusted，The newspaper where the newspaper is located to go through the corresponding change procedures;，The district and municipal bureaus of the place where the locations are located are processed in accordance with the "Measures for the Supervision and Administration of Medical Device Management"。
Article 22 Medical Device Production and Operation Enterprise、The unit as the commissioner shall bear the responsibility of the enterprise，Responsible for the quality and safety of the purchase of the product。Medical equipment storage and distribution enterprises and client should sign a written agreement with legal effect，Clarify the legal responsibility and obligations of both parties，and assume and fulfill the corresponding responsibilities and obligations in accordance with the agreement。
Article 23 Daily supervision and inspection of medical equipment storage and distribution enterprises，The district and municipal bureaus of the place where it is located，Set up districts and cities to establish regulatory files for storage and distribution enterprises，Supervision is mainly on -site inspection，illegal acts，Punishment in accordance with the law，The serious plot，Nuclear selling its storage and distribution business scope。
Article 24 Daily inspections found problems involving false stake betting appentrustment，Especially for the non -commissioned business records during the agreement between the two parties，Let's verify the situation in a timely manner to report the commissioner and the district and municipal bureau where the trustee is located，Decided，It is confirmed that there is a false commission or trusted behavior，Penalties for the commissioner's changes in accordance with the changes in operating conditions，Entrusted by the trustee is directly incorporated into the credit rating evaluation。
Article 25 Medical equipment storage and distribution enterprises to supervise the supervision of regulatory departments、Investigation of bad events should be actively cooperated。
Chapter 6 Attachment
Article 26 These measures are explained by the Shaanxi Food and Drug Administration。
Article 27 This method is implemented after 30 days from the date of release，Valid for five years。
