The construction of my China's medical device regulatory system began with the implementation of the "Medical Device Management Regulations" in 2000. After two revisions in 2014 and 2017, the framework of the regulatory system has been basically established. In order to facilitate medical device practitioners to quickly grasp the key points of regulatory documents, this article will use the registration, production, operation, use, supervision and management of the medical device product life cycle as the framework for the relevant supporting regulatory documents before and after the listing of medical devices. , To sort out the main points of the legal documents in each link, hoping to become a necessary legal manual for practitioners related to medical equipment.
What is a medical device manual？
Article 3 of the "Regulations on the Administration of Instructions and Labels for Medical Devices" (Order No. 6 of the State Food and Drug Administration) clearly stipulates that the instructions for medical devices are made by the registrant or filing person of the medical device and provided to the user with the product, covering the Basic information about product safety and effectiveness, technical documents used to guide correct installation, commissioning, operation, use, maintenance, and maintenance.
In daily work, the manual not only refers to what we call the manual, but also the most common documents about the product description provided to the user with the product, such as: quick operation card, user guide, product manual, user manual, etc. The instructions are essential. Some are called differently. In order to help users use the device quickly and correctly, some manufacturers attach a quick operation card or attach it to the device body. As long as it is provided with the product, it belongs to the scope of control.
The main contents of the medical device manual
According to Article 10 of the "Regulations on the Administration of Medical Device Instructions and Labels" (State Food and Drug Administration Order No. 6), medical device instructions should generally include the following:
1. Product name, model, specification
2. The name, domicile, contact information and after-sales service unit of the registrant or recorder, and the imported medical device shall also indicate the name, domicile and contact information of the agent;
3. The name, domicile, production address, contact information, and production license number or production record certificate number of the production enterprise. If production is entrusted, the name, domicile, production address, production license number or production record certificate number of the entrusted enterprise shall also be marked ；
4. Medical device registration certificate number or filing certificate number;
5. Number of product technical requirements;
6. Product performance, main structural composition or composition, and scope of application;
7. Contraindications, precautions, warnings and reminders;
8. Installation and use instructions or pictures, medical devices used by consumers themselves should also have special instructions for safe use;
9. Product maintenance and maintenance methods, special storage and transportation conditions and methods;
10. Production date, use period or expiration date;
11. Parts list, including parts, accessories, replacement cycle of worn-out parts and instructions on replacement methods, etc.;
12. Explanation of graphics, symbols, and abbreviations used in medical device labels;
13. The date of compilation or revision of the manual;
14. Other content that should be marked.
For reusable medical devices, in accordance with Article 12 of the Regulations on the Administration of Medical Device Instructions and Labels (Order No. 6 of the Food and Drug Administration), the reusable treatment process, including cleaning, disinfection, The method of packaging and sterilization and the number of repeated use or other restrictions.
Surgaid Medical (Xiamen) Co., Ltd
Surgaid Medical (Xiamen) Co., Ltd has been committed to surgical product development ,production and marketing for 10 more years . In particular, minimally invasive surgical products. Minimally invasive surgery is a surgical direction of development. Such as Disposable Laparoscopic Trocar, Linear Cutter Stapler, Circular Stapler, PPH, and so on.
Manufacturing our own Surgical products allows us to have complete control over the design and evolution of our products. We are able to adapt quickly to the constantly evolving healthcare market and offer high quality, single-use, cost-effective solutions that directly compete with global market-leaders.
Surgaid products:
For more product information at https://www.surgaid-medical.com/