Medical monitors are not managed as medical devices in mainland China, so they cannot obtain a medical device registration certificate.
Ordinary monitors have environmental protection and electromagnetism-related certifications. Medical monitors not only have environmental protection and electromagnetism related certificates, but more importantly have medical industry certificates before they can enter the medical field and be recognized by the law.
As China CCC certification. 3C certification: China Compulsory Certification, English name China Compulsory Certification, abbreviation CCC. 3C certification of the full name of "China Compulsory Product Certification", which is the Chinese government for the protection of consumer safety and national security, to strengthen product quality and safety, and to enhance the quality of products. Personal safety and national security, strengthen product quality management, in accordance with laws and regulations to implement a product conformity assessment system.
Expanded
According to the "Supervision and Administration of Medical Devices Regulations", Chapter IV, Article 30 provides that: engaged in the operation of Class II medical devices, by the business enterprise to the local municipal people's government of the municipal government of the food and drug supervision and management department for the record and submit it to comply with the conditions of the provisions of Article 29 of the Regulations of the proof of information.
(Article 29 to engage in the operation of medical devices, there should be with the scale and scope of operation of the business premises and storage conditions, and with the operation of medical devices and quality management system and quality management organizations or personnel.)
Opening the second class of medical device manufacturing enterprises must have the following conditions:
1, the person in charge of the enterprise shall have secondary education or above or junior title.
2, the person in charge of the quality inspection organization should have college education or above or intermediate or above title.
3, the enterprise should occupy the corresponding proportion of the total number of employees above the junior title of engineering and technical personnel.
4, the enterprise should have the appropriate product quality inspection capabilities.
5, there should be with the production of products and the scale of production, warehousing space and environment.
6, with the appropriate production equipment.
7, the enterprise should collect and save and enterprise production, business-related laws, regulations, rules and relevant technical standards.
8, the production of sterile medical devices, should have a production site in line with the provisions.
Baidu Encyclopedia - Class II Medical Devices