1, understand the laws and regulations: before applying for a class of medical devices business license, it is recommended to understand in detail the relevant laws and regulations of the country or region, and study the types of licenses needed and requirements. You can refer to the official websites of the National Health and Wellness Commission, the Food and Drug Administration or other relevant agencies for the latest regulations and guidelines;
2. Prepare the information: According to the laws, regulations and relevant requirements, prepare the information needed to apply for a Class I medical device business license. Usually, these materials may include enterprise registration information, proof of business premises, organizational structure and personnel setup, quality management system, product registration certificates and so on. Ensure that the preparation of the information is complete and meets the requirements;
3. Submit the application: Submit the prepared information and application form to the relevant regulatory agencies or departments. The specific processing organization may vary from country to country and region to region, it may be the health and wellness department, food and drug regulatory authority or other relevant agencies. Follow the specified application process and requirements to ensure the accuracy and completeness of the application materials;
4. Review and approval: The regulatory agency or department will review the application and may conduct on-site verification. They will assess whether the enterprise complies with laws, regulations and requirements, including business premises, equipment, personnel qualifications, quality management system and other aspects. If the audit is passed, a Class I medical device business license will be issued.
To engage in the production of medical devices, it should have the following conditions:
1, there are production sites, environmental conditions, production equipment, and professional and technical personnel suitable for the production of medical devices;
2, there are institutions or full-time inspectors capable of carrying out quality inspections of the medical devices produced, as well as inspection equipment;
3, there is a system of management to ensure the Medical device quality management system;
4, with the production of medical devices compatible with the after-sales service capabilities;
5, in line with the product development, production process documentation requirements.
In summary, before applying for a class I medical device license, it is recommended to understand in detail the relevant laws and regulations of the country or region and study the type of license needed and requirements. You can refer to the official websites of the National Health and Wellness Commission, the Food and Drug Administration or other relevant agencies for the latest regulations and guidelines; and prepare the information needed to apply for a Class I medical device license according to the laws, regulations and relevant requirements. Usually, such information may include enterprise registration information, proof of business premises, organization and personnel setup, quality management system, product registration certificates and so on. Ensure that the preparation of information is complete and meets the requirements; submit the prepared information and application forms to the relevant regulatory agency or department. The specific processing organization may vary from country to country and region to region, it may be the health and wellness department, food and drug regulatory authority or other relevant agencies. Follow the specified application process and requirements to ensure the accuracy and completeness of the application materials; the regulatory agency or department will review the application and may conduct on-site verification. They will assess whether the enterprise complies with laws, regulations and requirements, including business premises, equipment, personnel qualifications, quality management system and other aspects. If the audit passes, it will be granted a Class I medical device business license.
Legal basis:
Article 5 of the Regulations for the Supervision and Administration of Medical Devices
The research and development of medical devices should follow the principles of safety, efficacy and economy. The state encourages the research and innovation of medical devices, plays the role of market mechanism, promotes the popularization and application of new technology of medical devices, and promotes the development of medical device industry.
Article 32
Engaged in the production of Class II and Class III medical devices, shall apply to the local provincial, autonomous regions and municipalities directly under the Central People's Government of the People's Government of the drug supervision and management department to apply for production licenses and submit their compliance with the conditions of the provisions of Article 30 of the Regulations of the relevant information as well as the production of medical devices, the registration certificate.
To accept the application for production license drug supervision and management department shall review the application information, in accordance with the State Council drug supervision and management department to develop the requirements of the quality management standard for the production of medical devices for verification, and from the date of acceptance of the application within 20 working days to make a decision. To meet the prescribed conditions, permission is granted and issued to the medical device production license; does not meet the prescribed conditions, not licensed and a written explanation of the reasons.
Medical device manufacturing license is valid for five years. The expiration of the validity of the need for continuation, in accordance with the provisions of the relevant administrative licensing law for continuation procedures.