NEWS
27
2022-04
JSMPA 2022 Circular No. 10 Circular on Implementing Online Handling of Administrative Approval Matters for Medical Devices
2022-04-27
24
2022-03
NMPA Announcement No. 13 of 2022 Announcement on the issuance of guidelines for the preparation of annual self-inspection reports for medical device quality management systems
2022-03-24
24
2022-03
NMPA 2022 releases three normative documents including "Guidelines for Compiling Annual Self-Inspection Reports for Medical Device Quality Management System"
2022-03-24
24
2020-07
Five-character quatrains "Inspirational Song"
This inspirational song focuses on explaining the conscientiousness of Aohua's work and the spirit of excellence in products. Each product is the result of the efforts of Aohua employees!
2020-07-24
24
2020-07
Five-character quatrains "Praise of Spring and Autumn"
Aohua has experienced 20 years of ups and downs, and no one may know better than the boss himself about the ups and downs in the past 20 years. Making medical equipment is like a poem in the Spring and Autumn Period. Every product is hard-won. Every step of development is the result of careful construction, and the youth generation of Aohua is continuing to write magnificent poems!
2020-07-24
24
2020-07
Five-character quatrains "Dan Xin Ke Jian"
Aohua's corporate culture: win-win, integrity, innovation, hard work, never give up! Aohua is adhering to the blood and heart, casting every product with heart, and they will always pursue excellence, innovation, integrity, unity, professionalism and efficiency!
2020-07-24
04
2020-10
The company has passed ISO13485:2016 quality management system certification
2020-10-04
27
2022-04
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
24
2022-03
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
24
2022-03
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
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