The process and key points of the three types of medical device registration certificate on behalf of the process

Introduction: The provisions of the "supervision and management of the production of medical devices", the opening of the second class, the third class of medical device manufacturers, should be located in the provinces, autonomous regions and municipalities directly under the central drug supervision and management department to apply for a production license, the first class of medical device manufacturers for the record. Here to explain the registration process and requirements for class III medical devices.

One, the registration of class III medical devices to where to declare:

National regulations, the registration of class III medical devices by the National Bureau of acceptance and examination and approval; Class II medical devices have the acceptance of the provincial Drug Administration and examination and approval.
PS: From a variety of sources have been news, the registration of Class II medical devices may be the future by the National Bureau of acceptance and examination and approval, but have not yet seen the express policy release. The policy has not been published.

Two, three types of medical device registration general process:

Three types of medical device registration process is as follows:

Three, three types of medical device registration declaration information:

(a) "Medical Device Manufacturing Enterprises to start the application form" (the original) (including a power of attorney and a copy of the identity card of the delegate, and application for a copy of the medical device manufacturer's application form). A copy of the commissioner's identity card, and the authenticity of the application materials to ensure the statement).

(B) a copy of the business license.

(C) The applicant holds a copy of the production of medical device registration and product technical requirements.

(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 documents; production management, quality inspection positions practitioners, academic qualifications, titles list.

(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 the structural composition of the product, the principle, the intended use of the description and product standards).

(vii) the production site documents, there are special requirements for the production environment should also be submitted to the facilities, the environment, a copy of the documents; generally include proof of ownership of the house or lease agreement and a copy of the lessor's real estate certificate, the general layout of the plant, the main production workshop floor plan.

(h) the main production equipment and inspection instruments list (original).

(ix) quality manual and program documents (original).

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