Food and Drug Administration to repeal two medical device industry standards
Pharmaceutical Network November 6 hearing recently, the State Food and Drug Administration released the 'on the repeal YY / T 0127.2-2009' Biological Evaluation of Dental Device Unit 2: Test Methods Acute Systemic Toxicity Test: intravenous route 'and other 2 Announcement of the Industry Standard for Medical Devices (No. 130 of 2017)
According to the announcement, in accordance with the relevant requirements of the "Notice of the State Council on Issuing the Proposal on Deepening the Reform of Standardization Work" (Guo Fa [2015] No. 13) medical instruments Industry standard integration and streamlining and centralized review, decided to repeal YY / T 0127.2-2009 "Biological evaluation of oral medical devices Unit 2: Test methods for acute systemic toxicity test: intravenous route" and YY / T 0244-1996 "oral material biological test Methods Short-term systemic toxicity test: Oral route "2 medical device industry standards.
It is reported that this is the only medical device industry standard CFDA has issued since the beginning of this year.
Correspondingly, this year CFDA released a medical device industry standard bulletin, including:
September 28 General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China on the Approval of the Issuance of Industry Standards for 7 Medical Devices such as YY / T 0661-2017 "Semisynthetic Polylactide Polymer and Copolymer Resins for Surgical Implants" (No. 118 of 2017)
July 21 General Administration of Quality Supervision, Inspection and Quarantine announced on the approval of the issuance of the 8 medical device industry standards and 1 modification list (No. 84 of 2017) of "Disposable Sterile Catheters for Endovascular Catheters, Part 1: General Requirements"
On May 5, the General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China on the Approval of the Issuance of 28 Medical Device Industry Standards such as "One-off Centrifugal Plasma Separators" (No. 49 of 2017)
April 1, Administration of Quality Supervision, Inspection and Quarantine announced on the approval of the 40 medical device industry standards (No. 38 of 2017) issued by the State Administration of Taxation, "Part 7 Biological Evaluation of Dental Medical Devices: Application of Dental Dentation"
March 3 General Administration of Quality Supervision, Inspection and Quarantine, Ministry of Commerce, the State Administration of Industry, Announcement on Approving 10 Industry Standards for Medical Devices (No. 25 of 2017) on "Test Method for Contacting Wound Dressing Part 5: Antibacterial"
February 4 General Administration of Quality Supervision, Inspection and Quarantine approved the release of YY / T 0287-2017 "medical device quality management system for Regulations Requirements "medical device industry standard Notice (2017 No. 11)
It can be seen, the current medical device industry standards are stepping up the process of formulation, but due to changes brought by various factors, a few standards have not adapted to the situation needs, need to be amended or abolished, but the abolition of the very small number.
