About the supervision and administration of medical health materials and dressings products

Provinces, autonomous regions and municipalities directly under the central government and drug administration:

According to the current health materials and dressings (including medical gauze and absorbent cotton, etc.) related to product registration and regulatory issues, in order to further strengthen the supervision and administration of the hygiene materials and dressings products, to ensure that the use of safe, effective, is responsible for the supervision and administration of hygiene materials and dressings products clearly specified below, notice the following:

A, medical health materials and dressings (including medical gauze and absorbent cotton, bandages, disposable gown, etc.) products shall be according to the supervision and management of medical apparatus and instruments, uniformly, and by our medical equipment department regulations and technical requirements shall implement the regulations on the supervision and administration of medical devices and related laws and regulations and relevant standards.

Second, according to the regulation of the medical device classification rules and requirements, at present our medical equipment department are working on compiling "medical device products catalog", in not released prior to the implementation of the "directory", medical health materials and dressings products temporarily according to the second category of medical equipment management, the absorbability of the dressing products according to the third class medical equipment management.All the medical health materials and dressings have been handled according to the first kind of medical device product registration. please inform production unit to correct as soon as possible, and to deal with product registration (due on June 30, 2001).If any decision is not clear or have questions, please provide the product standards, product manuals, information about the product technical characteristics and application scope, etc, to inform medical equipment company.

Three, to regulate the supervision and management of medical health materials and dressings products, now I have begun to the product batch on standards for medical devices industry revised plan. and will be released as soon as possible to implement.

State drug administration

January 15, 2001