State regulations, three types of medical device registration by the National Bureau of acceptance and approval; two types of medical devices have the provincial Drug Administration acceptance and approval. ps: from various channels has been news, the registration of two types of medical devices in the future may be accepted by the National Bureau of acceptance, approval, but have not yet seen the release of the policy of the explicit.
Two, three types of medical devices registration general process:
Three types of medical devices registration process is as follows:
Three, three types of medical devices registration declaration materials:
(a) "Medical Device Manufacturing Enterprises to start the application form" (the original) (including a power of attorney and a copy of ID card of the person to be entrusted, as well as the authenticity of the application materials to ensure the statement).
(2) A copy of the business license.
(c) A copy of the registration certificate of the medical device and the technical requirements of the product held by the applicant.
(D) legal representative, a copy of the identity of the person in charge of the enterprise; a copy of the appointment of the person in charge of the enterprise; production management, quality inspection positions practitioners list of academic qualifications, titles.
(E) production, quality and technical departments responsible for the identity, education, title certificate and work resume (copy).
(F) the scope of products to be produced, varieties and related product profiles (product profiles include at least a description of the product's structural composition, principles, intended use and product standards).
(vii) the production site documents, there are special requirements for the production environment should also be submitted to the facilities, environment, a copy of the documents; generally include proof of ownership of the house or lease agreement and a copy of the lessor's property certificates, the general layout of the plant, the main production workshop layout.
(H) the main production equipment and inspection instruments list (original).
(IX) quality manual and program documents (original).
(J) process flow diagram (original).
(xi) Self-inspection form of the manufacturer (original).
(xii) Other supporting information.
Note: Other based on the specific provisions of the local Drug Administration to prepare.
Note: The other according to the specific regulations of the local Drug Administration to prepare.