Additionally, I would like to ask you, you said that the determination of unqualified, worth is the registration of medical devices is the product test failed, or in the production process of the test failed?
Article 61 One of the following circumstances, in accordance with the "supervision and management of medical devices regulations" Article 63 of the provisions of the penalty:
(a) the production of medical devices did not obtain the certificate of registration of the second class, the third class of medical devices;
(b) unauthorized to engage in the production of the second class, the third class of medical devices;
(c) the production of medical devices beyond the scope of production or with the production of products. Production scope or inconsistent with the medical device production product registration form contained in the production of Class II, Class III medical devices;
(D) in the unauthorized production site production of Class II, Class III medical devices;
(E) Class II, Class III medical devices entrusted to the termination of the production of the entrusted party to continue to produce entrusted products.
Article 62 "Medical Device Manufacturing License" expires, not in accordance with the law for continuation, still continue to engage in the production of medical devices, in accordance with the "supervision and management of medical devices regulations" shall be punished in accordance with the provisions of Article 63.
Article 63 Provide false information or take other deceptive means to obtain a "medical device manufacturing license", in accordance with "supervision and management of medical devices regulations" Article 64, paragraph 1, shall be punished.
Article 64 engaged in the production of Class I medical devices not in accordance with the provisions of the food and drug supervision and management department for the record, in accordance with the "Supervision and Management of Medical Devices Regulations" Article 65, paragraph 1, shall be punished; for the record to provide false information, in accordance with the "Supervision and Management of Medical Devices Regulations" Article 65, paragraph 2, shall be punished.
Article 65 of the forgery, alteration, trading, leasing, lending "medical device production license", in accordance with "Regulations for the Supervision and Management of Medical Devices" Article 64, paragraph 2, shall be punished.
Forgery, alteration, trading, leasing, lending of medical device production record certificate, by the food and drug supervision and management department at or above the county level shall order correction and impose a fine of 10,000 yuan.
Article 66 One of the following circumstances, in accordance with the "supervision and management of medical devices regulations" Article 66 of the provisions of the penalty:
(a) the production of medical devices does not meet the mandatory standards or does not comply with the registered or filed product technical requirements;
(b) medical device manufacturers do not follow the registered, filed product technical requirements of the organization of production
(c) entrusted to do not have the conditions of the production of medical devices or the production of entrusted parties to manage the behavior.
Article 67 of the medical device manufacturers of production conditions change, no longer meet the requirements of the quality management system for medical devices, not in accordance with the provisions of these measures to rectify, stop production, report, in accordance with the "supervision and management of medical devices regulations" Article 67 of the provisions of the penalty.
Article 68 of the medical device manufacturers are not required to provinces, autonomous regions, municipalities directly under the Central Government or the municipal food and drug supervision and management department to submit the enterprise quality management system operation self-examination report, in accordance with the "supervision and management of medical devices regulations" Article 68 of the provisions of the penalty.
Article 69 One of the following circumstances, by the food and drug supervision and management department at or above the county level shall give a warning, ordered to make corrections within a certain period of time, and may impose a fine of 30,000 yuan or less:
(a) the factory medical equipment is not in accordance with the provisions of the test;
(b) the factory medical equipment is not in accordance with the provisions of the accompanying documents of conformity;
(c) the factory medical equipment is not in accordance with the provisions of Article 16 of the Regulations for the supervision and management of medical devices. In accordance with the provisions of Article XVI of these measures for "medical device manufacturing license" change registration;
(d) not in accordance with the provisions of the commissioned production for the record;
(e) medical device products discontinued for more than one year and no similar products in production, without the location of the provinces, autonomous regions, municipalities directly under the Central Government or municipal food and drug supervision and management departments to verify compliance with the requirements of resumed Production;
(F) to supervise and inspect the food and drug supervision and management departments to conceal the situation, provide false information or refuse to provide true information reflecting its activities.
There are cases listed in the preceding paragraph, the circumstances are serious or cause harmful consequences, is a violation of the "supervision and management of medical devices regulations" related provisions, in accordance with the "supervision and management of medical devices regulations" shall be punished.