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State Food and Drug Administration: Medical device coding date, variety officially released

  • Categories:Industry news
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  • Time of issue:2019-10-17 17:45
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(Summary description)Variety range: According to the degree of risk and regulatory needs, some high-risk third-class medical devices such as active implants and passive implants were identified as the first batch of medical device unique identification varieties.

State Food and Drug Administration: Medical device coding date, variety officially released

(Summary description)Variety range: According to the degree of risk and regulatory needs, some high-risk third-class medical devices such as active implants and passive implants were identified as the first batch of medical device unique identification varieties.

  • Categories:Industry news
  • Author:
  • Origin:
  • Time of issue:2019-10-17 17:45
  • Views:
Information
Variety range: According to the degree of risk and regulatory needs, some high-risk third-class medical devices such as active implants and passive implants were identified as the first batch of medical device unique identification varieties.
 
Nine categories and 64 varieties of cardiac pacemakers, hip prostheses, and plastic injection fillers were included in the first batch of product catalogues for the unique identification of medical devices (see attachment for specific product catalogues).
 
The schedule is:
 
The date of the draft for comment is 2020, and the official version is postponed for 2 months.
 
For medical devices listed in the first batch of product catalogues, the registrant shall carry out the following work in an orderly manner in accordance with the time limit requirements:
 
(1) Unique identification code
 
From October 1, 2020, the medical devices produced shall have the unique identification of medical devices;
 
Medical devices manufactured before October 1, 2020 may not have a unique identifier for medical devices. The date of manufacture is based on the medical device label.
 
(2) Unique identification registration system submission
 
From October 1, 2020, when applying for the first registration, renewal registration or registration change, the registered applicant/registrant shall submit the product identification of the smallest sales unit in the registration management system.
 
The product identification is not a registration review item, and the individual change of the product identification does not belong to the registration change category.

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