Announcement of Jiangsu Provincial Drug Administration on Implementing Online Handling of Administrative Approval Matters for Medical Devices 2022 No. 10

In order to further promote the administrative approval of medical devices in Jiangsu Province and strengthen service guidance, in accordance with the "Regulations on the Supervision and Administration of Medical Devices", "Administrative Measures for Medical Device Registration and Filing", "Administrative Measures for Registration and Filing of In Vitro Diagnostic Reagents", and "Medical Device Production Supervision and Administration Measures" and other laws and regulations, combined with the State Drug Administration's "Announcement on the Announcement of the Format of Medical Device Registration Application Materials and Approval Documents", "Announcement on the Announcement of In Vitro Diagnostic Reagent Registration Application Materials Requirements and Approval Document Formats", "On the Implementation of "Medical Device Registration Application Materials" According to the requirements of the “Measures for the Supervision and Administration of Device Production” and the “Measures for the Supervision and Administration of Medical Device Operation” and other requirements, from May 1, 2022, all the administrative examination and approval matters for medical devices in Jiangsu Province will be handled online.

2022-04-27

Announcement on the issuance of guidelines for the preparation of annual self-inspection reports of the medical device quality management system (No. 13 of 2022)

In order to strengthen the supervision of medical device production and ensure the safety and effectiveness of medical devices, according to the second paragraph of Article 35 of the "Regulations on the Supervision and Administration of Medical Devices", the State Drug Administration organized the revision of the "Annual Self-Inspection Report of the Medical Device Quality Management System". Guidelines, is hereby issued, and will come into force on May 1, 2022. The original State Food and Drug Administration's "Notice on Issuing Guidelines for Compiling Annual Self-inspection Reports on the Quality Management System of Medical Device Manufacturers" (2016 No. 76) shall be repealed at the same time.

2022-03-24

The State Food and Drug Administration issued three normative documents including "Guidelines for Compiling Annual Self-Inspection Reports for Medical Device Quality Management System"

In order to strengthen the supervision of medical device production and ensure the safety and effectiveness of medical devices, in accordance with the relevant provisions of the Regulations on the Supervision and Administration of Medical Devices and the Measures for the Supervision and Administration of Medical Device Production, the State Food and Drug Administration has recently revised and issued the Annual Self-Inspection of the Medical Device Quality Management System. Report Compilation Guidelines" and "Catalogue of Prohibited Entrusted Production of Medical Devices", and formulated and issued "Guidelines for the Compilation of Quality Agreements for Entrusted Production of Medical Devices". The above three normative documents will be implemented from May 1, 2022.

2022-03-24

Circular of the State Food and Drug Administration on Matters Concerning the Implementation of the Measures for the Supervision and Administration of the Production of Medical Devices and the Measures for the Supervision

"Measures for the Supervision and Administration of Medical Device Production" (Order No. 53 of the State Administration for Market Regulation) (hereinafter referred to as the "Production Measures") "Measures for the Supervision and Administration of Medical Device Operation" (Order No. 54 of the State Administration for Market Regulation) (hereinafter referred to as the "Measures for the Supervision and Administration of Medical Devices" (Order No. 54 of the State Administration for Market Regulation) Operational Measures") has been issued and will come into force on May 1, 2022.

2022-03-23

Measures for the Supervision and Administration of Medical Device Production

In order to strengthen the supervision and management of medical device production, standardize medical device production activities, and ensure the safety and effectiveness of medical devices, these Measures are formulated in accordance with the Regulations on the Supervision and Administration of Medical Devices.

2022-03-10

The company's new website is online

2022-04-01

The company's global portal 2022 version (standard version) website was officially launched

In March 2022, China Enterprise Power, a pioneer in building a domestic website, assisted Nantong Aohua Medical Supplies Co., Ltd. to upgrade and build the website. The design layout and functional sections of the entire page are more in line with the concept of green and healthy development and sustainable management of medical devices.

2022-04-01

2014 Spring Medical Equipment Expo (Shenzhen)

2014 Spring Medical Equipment Expo (Shenzhen)

2014-11-24

The second centralized procurement of medical consumables and testing reagents for medical institutions in Huizhou in 2015

Qualification requirements: (1) Manufacturers of medical consumables should obtain the "Business License" and "Medical Device Production License" in accordance with the law. Manufacturers of test reagents shall have corresponding production qualifications in accordance with national regulations on in vitro diagnostic reagents. Manufacturers of disinfectants shall obtain a Sanitary License in accordance with the law. (2) Good business reputation. (3) It has the ability to guarantee the supply of medical consumables and testing reagents necessary for the performance of the contract. (4) Have a good record of paying taxes according to law. (5) In the two years before participating in the centralized procurement activities, there is no serious illegal record in the business activities. (6) Supplier qualification organized by service agencies

2015-01-05

Bid Information

The Nanjing bidding ended in July 2015.

2015-07-10