Food and Drug Administration Office [2013] No. 34

The food and drug administrations (drug administrations) of all provinces, autonomous regions and municipalities directly under the Central Government:

In order to clarify the management categories of applied products and standardize the registration of related medical devices, since April 2004, the State Administration has successively issued the Notice on Issues Related to the Management of Pharmaceutical and Equipment Combination Products (State Food and Drug Administration [2006] No. 519), the Opinions on the Registration of Far Infrared Paste Products (State Food and Drug Administration [2007] No. 282) and the Notice on Issues Related to the Registration of Pharmaceutical and Equipment Combination Products (No. 16, 2009), and successively issued relevant product classification definition documents, the management attributes and classification principles of the application products have been clearly defined, and special work to standardize the registration of such products has been deployed many times, and phased results have been achieved. In order to further consolidate the achievements of the work, in accordance with the arrangement of the key work of national medical device supervision in 2013, the State Administration has decided to organize and carry out a special inspection of the registration of medical devices for application. The relevant matters are hereby notified as follows:

1. work objectives
The scope of this registration special inspection work is made of non-woven fabrics and other materials as a backing, containing drugs and/or heat, magnetic and other materials of the application of products. Through this work, further unify the registration and approval standards of related products, and effectively solve the problems of non-medical devices in accordance with medical device approval and high-class low-approval.

2. main tasks
(I) Inspection Principles
1. For the application products containing only chemical components, Chinese herbal medicines (or natural plants) and their extracts, the intended purpose and mechanism of action of adding such components must be explained and verified, regardless of whether they are included in the pharmacopoeia. If the contained ingredients play a pharmacological, immunological or metabolic role, or cannot prove that they do not play a pharmacological, immunological or metabolic role, they should not be registered as medical devices.
2. For the application products containing drug ingredients and magnetic or heating materials, which cannot be proved to be mainly based on physical effects, they shall not be registered and managed as medical devices. Drug-containing devices with physical effects should be managed in accordance with Class III medical devices.
3. The Ministry of Health announced the "Notice on Further Regulating the Management of Health Food Raw Materials" (Wei Fa Jianfa [2002] No. 51) in the "List of Items that Are Both Food and Medicine" and "List of Items that Can be Used for Health Food". It is a regulation for the management of health food raw materials and cannot be used as a basis for the management of medical devices for sticking products containing these ingredients.
4. Sticking products that only contain magnetic or fever materials and other substances that play the role of physical therapy, and other added ingredients that have therapeutic or auxiliary therapeutic effects should be managed in accordance with the second category of medical devices.
Contents of (II) inspection
According to the above principles, the first and second types of applied medical devices within the jurisdiction are summarized and inspected, mainly including whether the approved products have the approval of non-medical devices as medical devices; Whether there is a situation of high class and low batch; Whether the approved product name and scope of application and other registration information are exaggerated, asserted efficacy and easy to cause confusion with the drug name, etc.

3. job requirements
(I) in accordance with the first type of medical device approval of the application of the special inspection work, into the domestic first type of medical device registration work inspection synchronization. The provincial food and drug supervision and administration departments shall organize the municipal bureaus with districts within their jurisdiction to formulate a good work plan and implement it according to the inspection plan for the registration of category I medical devices in the territory and according to the regulatory characteristics of the application products within their jurisdiction.
(II) the provincial food and drug supervision and administration department to carry out the special inspection work of the attached products approved by the second type of medical devices in their jurisdiction, they should refer to the domestic first type of medical device registration inspection plan, and in accordance with the corresponding work stage, work requirements and problems The principle of handling, formulate a special inspection work plan and organize its implementation.
The working materials formed by the special inspection of (III) application products shall be submitted in accordance with the contents and requirements of Annex 2 and Annex 3 of the domestic first-class medical device registration inspection plan.
(IV), according to the situation reported by various localities, the State Bureau set up an inspection team to supervise the inspection work in some areas, further understand the problems existing in the registration of sticking products, and urge all localities to rectify and implement them. After the supervision work is completed, the Medical Device Supervision Department of the State Administration will notify the inspection.
Food and drug supervision and administration departments at all levels in the (V) should pay attention to strengthening publicity and reporting, create a good atmosphere, enhance the sense of responsibility, law-abiding, integrity and self-discipline of enterprises, enhance consumers' awareness of self-protection, and timely report the results of special inspection and registration management.

Office of the State Food and Drug Administration
March 18, 2013