We are a medical device manufacturer. Disposable Diathermy Pencil is one of our products. Let's introduce the management system of disposable medical devices.
Article 1 In order to strengthen the supervision and management of single-use sterile medical devices and ensure product safety and effectiveness, according to the "Medical
Regulations on the Supervision and Administration of Medical Devices to formulate this system.
Article 2 A medical institution shall have a "Medical Device Manufacturing Enterprise License" or a "Medical Device Operating Enterprise License"
Enterprises licensed to purchase sterile instruments. Medical institutions should establish a sterile device procurement and acceptance system, strictly implement and do
Good record. Purchasing records should at least include: company name, product name, model specification, product quantity, production
Production batch number, sterilization batch number, product expiration date, etc. According to the records, it should be possible to trace the source of purchase of each batch of sterile instruments.
Article 3 Medical institutions shall establish a system for the destruction of sterile instruments after use. Used sterile instruments must be
Destroy it so that its parts no longer have the function of use, after disinfection and harmless treatment, and make a record. Medical institutions shall not
Reuse sterile instruments.
Article 4 If medical institutions find unqualified sterile instruments, they should immediately stop using and seal them up, and report to the institute in a timely manner.
The local drug supervision and administration department shall not deal with it without authorization. Sterile instruments that are verified to be unqualified are subject to local drug supervision
handled under the supervision of the management department.
Article 5 Medical institutions that use substandard sterile instruments and cannot identify the producers of substandard products shall be deemed to have used them.
Products without product registration certificate; if the supplier of substandard products cannot be specified, it is deemed that there is never a "Medical Device Operation Enterprise License"
companies purchase products.
Article 6 When a serious adverse event occurs in a medical institution using sterile instruments, it should
Inside, report to the local provincial drug administration and health administration.
Article 7 A medical institution shall not conduct the following acts:
(1) Purchasing sterile instruments from illegal channels;
(2) Use sterile instruments with damaged small packages and unclear labels;
(3) Using expired and outdated sterile instruments;
(4) Use of medical devices without the "Medical Device Product Registration Certificate" and without the medical device product qualification certificate.
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