The validity period is five years.
According to the "supervision and management of the production of medical devices" in order to strengthen the supervision and management of the production of medical devices, standardize the production of medical devices, to ensure that medical devices are safe and effective.
According to the "supervision and management of medical devices regulations" developed by the "supervision and management of medical device production" Article XIII "medical device production license" is valid for five years, set out the license number, enterprise name, legal representative, responsible for the enterprise, residence, production address, the production range, the issuance of licensing department, the date of issuance and validity period and other matters.
Expanded Information
In order to meet the rare special personalized needs of clinical practice, standardize the supervision and management of customized medical devices, to ensure the safety and efficacy of customized medical devices.
The State Drug Administration (SDA) and the National Health Commission (NHC) jointly issued the Announcement on the Issuance of <Supervision and Administration of Custom-Made Medical Devices (Trial) > (hereinafter referred to as the "Provisions"), which will come into force on January 1, 2020, formally.
The Provisions*** are divided into six chapters***35 articles, including General Provisions, Record Management, Design and Processing, Use Management, Supervision and Administration and By-laws, which clearly define the definition of customized medical devices, record, design, supervision and administration requirements.
Considering that custom-made medical devices are only used for specific patients, the number is very small, and it is difficult to register through the current registration management mode, the "Provisions" explicitly implement the filing management of custom-made medical devices, custom-made medical device manufacturers and healthcare institutions *** with as the filer.
Baidu Encyclopedia-Medical Device Manufacturing License