CFDA Released 4 Industry Standards for Medical Devices

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CFDA Released 4 Industry Standards for Medical Devices

CFDA recently issued the No. 99 Announcement of 2017, which issued YY / T 1574-2017 “The guide of the alginate gel fixation or microencapsulation of the tissue engineering medical device products” and other 3 medical device industry standards, they will be implemented from September 1st, 2018.

1.   The guide of the alginate gel fixation or microencapsulation of the tissue engineering medical device products

  • Standard #: YY/T 1574-2017
    This standard applies to the evaluation of alginate gel fixation and microencapsulation.

2.   The guide of tissue engineering medical device – the evaluation bone formation activity of repair and replacement of bone tissue implants

  • Standard #: YY/T 1575-2017
    This standard applies to the implants that can repair and replace bone tissue defect.

3.   The guide of tissue engineering medical device – absorbable materials implantation test

  • Standard #: YY/T 1576-2017
    This standard applies to the absorption of biological materials in bone or soft tissue for longer than 30 days and less than 3 years in clinical use.

4. The guide of tissue engineering medical device – polymer scaffold microstructure evaluation

  • Standard #: YY/T 1577-2017
    This standard applies to the evaluation of polymer scaffold microstructure. 

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