Inquiry method: state administration of pharmaceutical products-> open government affairs-> normative documents.
In addition, you can query and download medical device policies, regulations and standard documents through the following websites:
China People's Procuratorate-Common Standards
Inquiry method: China, American Food and Drug Administration Research Institute-> Data Inquiry-> Medical Device Standard Inquiry.
Query Description: Also known as Medical Device Standard Management Center of National Medical Products Administration, it is a common website for standard query. You can view standard documents such as medical device standard catalogue, device industry standard, non-standard device recommended industry standard and medical device classification catalogue.
2. Medical device technology evaluation center-common guiding principles
Inquiry method: Medical Device Technology Evaluation Center-> Evaluation Science-> Guiding Principles
Inquiry note: The Medical Device Technical Review Center is responsible for the technical organization of the revision of the Guiding Principles, which is an important basis for its technical review. This website provides online preview and download of normative documents such as product registration and review guide. At the same time, some laws and regulations, departmental rules and documents are provided.
3. All documents (at home and abroad) include regulations, standards and guiding principles.
Inquiry method: Yuyu Medical Devices-> Industry Tools-> Policies and Regulations of China Medical Devices/Guiding Principles of China Medical Devices.
Inquiry Description: Official documents issued by the State Administration of Medical Products, Device Evaluation Center and more than 50 local government departments are included, including data information such as China's medical device policies and regulations, national and industrial standards for medical devices, guiding principles for various device evaluation, standard catalogues, technical requirements, etc.
The database is huge, and it also provides inquiries about international standards and policies and regulations of medical devices in other mainstream countries. It basically covers all kinds of documents related to medical devices and classifies them. The retrieval methods are diverse, easy to operate and practical. If you register, you can inquire for free, and support online preview and PDF file download.
4. Local US Food and Drug Administration-Inquire about laws, administrative regulations, departmental rules and local regulations
The local food and drug administration is responsible for the supervision and management of medical devices within its jurisdiction, and is a common website for inquiring about local laws and regulations, normative documents and supervision and inspection trends. Guangdong province, for example, Guangdong is->; Policy-> medical devices, you can query the relevant documents of national and Guangdong medical devices, but other working documents such as guiding principles, standard catalogues and technical requirements of medical devices are not supported.
5. Food and Drug Inspection Center of State Pharmaceutical Products Administration-collected some policies, regulations and on-site inspection questions.
Inquiry method: Food and Drug Inspection Center of State Pharmaceutical Products Administration-> Policies and Regulations/Interactive Communication
Inquiry Note: Organizers who formulate the inspection system specifications and technical documents for drugs, medical devices and cosmetics can inquire about some medical device laws and policies. You can pay attention to the on-site inspection, consultation and reply summary of medical device production under the interactive communication section.
6. National laws and regulations database-comprehensive laws and regulations query
Query method: national laws and regulations database-> keyword "medical devices"
Query Description: The official database of national industry-wide laws and regulations can query the original texts and explanations of medical device laws, administrative regulations and local regulations. Industry search is not supported, and regional search is supported.
The above is the website that supports the inquiry and download of medical device policies and regulations. Thank you for your adoption.