T/GDTEX 08-2020 Guidelines for Enterprises to Produce (Transfer) Medical Masks for Use in Healthcare Settings

Scope

Scope: This standard provides the terms and definitions for enterprises investing (or converting) to the production of medical masks, as well as general principles and working procedures. This standard applies to all enterprises in Guangdong Province that invest (or convert) to the production of medical masks. Main technical content: 1. Scope: This standard provides working procedures and guidance information for enterprises investing (or converting) to the production of medical masks. It applies to all enterprises in Guangdong Province that invest (or convert) to the production of medical masks. 2. Normative reference documents 3. Terms and definitions: This standard provides a definition of medical masks. 4. Working procedures 4.1 Preparation phase 4.1.1 Qualification application 4.1.2 Environmental facilities 4.1.3 Raw materials 4.1.4 Equipment 4.1.5 Personnel 4.1.6 Management system 4.1.7 Process conditions 4.2 Quality control 4.3 Administrative supervision According to the "Regulations on the Supervision and Management of Medical Devices" (Decree No. 650 of the State Council) and other relevant regulations, enterprises need to accept safety supervision and unannounced inspections by administrative authorities during the production process. The main checks include whether the production meets the technical requirements of the registered products, whether the enterprise's quality management system is effectively implemented, whether the production and operation conditions continuously meet legal requirements, and whether the product quality meets relevant standard requirements, etc.

Development Information

Related Standards