I. Definition and use of hollow capsules
Hollow capsule, as its name implies, is a kind of hollow capsule-like object. In the field of medicine, it is mainly used to package solid drugs or nutritional supplements, which is convenient for patients to use. Hollow capsules are usually made of edible materials such as gelatin or plant fibers, which have good biocompatibility and safety.
Second, the management of hollow capsules as medical devices
In China, medical devices refer to equipment, instruments, equipment, materials or other articles used to prevent, diagnose, treat, monitor or alleviate human diseases, injuries or disabilities. Hollow capsules are included in the management of medical devices because they play the role of packaging and assisting medication in the medical process.
Enterprises that produce and sell hollow capsules need to obtain corresponding medical device production licenses and business licenses to ensure that the products meet the requirements of relevant national standards and regulations. At the same time, enterprises need to establish a perfect quality management system to ensure the quality of hollow capsules is stable and reliable.
Third, the supervision and regulations of hollow capsules.
In order to ensure the safety and effectiveness of hollow capsules, China has formulated a series of relevant regulations and standards. For example, the Regulations on the Supervision and Administration of Medical Devices comprehensively regulates the production, operation and use of medical devices, requiring enterprises to strictly abide by relevant laws and regulations to ensure product quality and safety. In addition, there are special standards for hollow capsules, such as medicinal gelatin hollow capsules, which specify the materials, specifications and properties of hollow capsules in detail.
To sum up:
As a medical device, the production and sales of hollow capsules are strictly regulated by laws and regulations. Enterprises need to obtain corresponding licenses and establish a sound quality management system to ensure that products meet the requirements of relevant national standards and regulations. At the same time, the regulatory authorities should also strengthen the supervision of the hollow capsule market to ensure the safety of patients' medication.
Legal basis:
Regulations on the supervision and administration of medical devices
Article 4 provides that:
The state implements classified management of medical devices according to the degree of risk. Supervise and inspect the production, operation and use of medical devices, as well as the purchase of medical devices by medical device users.
Article 6 provides that:
The state implements classified registration management for medical devices. In China, the first category of medical devices is put on record, and the second and third categories of medical devices are registered. Overseas medical devices are subject to registration management. The State Council drug supervision and administration department is responsible for the registration and approval of Class III medical devices and imported Class II and Class III medical devices, as well as the filing of imported Class I medical devices. The pharmaceutical supervisory and administrative departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government are responsible for the examination and approval of the registration of Class II medical devices in China. The filing of Class I medical devices in China is the responsibility of the pharmaceutical supervisory and administrative department of the municipal people's government with districts.