Ministry of Health: Medical equipment problems will not be recalled and will be heavily penalized

The business club reported on August 1 that medical devices that are closely related to the health of the general public should be recalled if problems arise. The Measures for the Administration of Medical Device Recall (Trial) (hereinafter referred to as the “Measures”) has been issued by Order No. 82 of the Ministry of Health and has been officially implemented since this month. The reporter learned that after the implementation of the "Measures", companies that have hidden safety problems and do not take the initiative to recall medical devices will be given heavy penalties. If the recalled medical device causes damage to the patient, the patient may request compensation.

What kind of medical device to recall

“Medical devices with unreasonable risks that may jeopardize human health and life safety under normal use conditions” are within the scope of the recall referred to in the Measures.

The recall of medical devices refers to the medical device manufacturing enterprises that, in accordance with the prescribed procedures, take warnings, inspections, repairs, re-labels, amendments, and improvements to the specifications and software of the products of a certain type, model, or lot that have been defective in the market. Upgrade, replace, retract, destroy, etc. to eliminate defects.

The medical device manufacturing company is the main body that controls and eliminates product defects and should be responsible for the safety of the products it produces. Medical device manufacturers shall establish and improve the system for recalling medical devices as required, collect relevant information on the safety of medical devices, investigate and evaluate medical devices that may be defective, and promptly recall defective medical devices.

If a medical device operating company or user unit finds that there is a defect in the medical device it operates or uses, it shall immediately suspend the sale or use of the medical device, notify the medical device manufacturing enterprise or supplier in a timely manner, and report it to the drug regulatory authority; the use unit is Medical institutions shall also report to the health administrative department at the same time.

China will no longer be excluded from the recall

As this method is applicable to "recalls and supervision of medical devices sold within the territory of the People's Republic of China," this means that the same applies to imported medical devices. Experts believe that this will standardize the recall of multinational medical device companies in China.

According to public statistics, in 2010, the total output value of medical devices in China exceeded 100 billion, but among them, local device companies are mostly concentrated in the low-end market of conventional consumer products, and high-value-added large-scale equipment markets such as nuclear magnetic and CT are almost adopted by GE and Siemens. , Philips and other foreign companies monopolized. After the "Measures" were implemented, many multinational medical and mechanical companies, including Johnson & Johnson, could no longer be held responsible for the recall of China's exceptions in the global recall.

This time, in accordance with the requirements of the Measures, foreign manufacturers of imported medical devices that have recalled medical devices abroad should notify their designated agents in China to report to the State Food and Drug Administration in a timely manner; if recalls are conducted within the territory, they must be The agent appointed by him in China shall be responsible for the specific implementation according to the regulations.

According to the person in charge of the city's food and drug regulatory authority, this article will help prevent some medical device multinationals from excluding China from international product recalls.

Enterprises that find defects should take the initiative to recall

After the medical device manufacturing enterprise conducts investigation and assessment as required, if it finds that the medical device has a defect, it shall immediately decide to recall it.

If an overseas manufacturer of imported medical devices applies a recall of a medical device abroad, it shall notify its designated agent in China to report to the State Food and Drug Administration in a timely manner; if a recall is made in China, it shall be assigned by its agent in China. The regulations are responsible for the specific implementation.

The recall notice shall include at least the following contents: basic information such as the name and batch of recalled medical equipment; reasons for the recall; requirements for recall: such as immediate suspension of sales and use of the product, transfer of recall notice to relevant operating companies or use units, etc.; recall Treatment of medical devices.

Incomplete corporate recalls should be recalled

The drug regulatory department may organize experts to evaluate the recall plan submitted by the medical device manufacturer according to the actual situation. If the measures taken by the medical device manufacturing enterprise cannot effectively eliminate the defects, the medical device manufacturer shall be required to increase the recall rating and expand the recall. Range, shorten the recall time, or change the treatment of recalled products.

The medical device manufacturing enterprise shall have detailed records of the handling of recalled medical devices and report it to the drug regulatory department of the medical device manufacturing enterprise. If the product defects can be eliminated through warnings, inspections, repairs, relabeling, modification and improvement of manuals, software upgrades, replacements, destructions, etc., the above actions can be completed at the product location. If it is necessary to destroy, it shall be destroyed under the supervision of the drug regulatory department of the place of destruction.

The drug regulatory authority evaluates the recall effect. After review and evaluation, if the recall is not thorough and the defect has not been effectively eliminated, the drug regulatory authority shall require the medical device manufacturer to recall it again.

Drug regulatory authorities have the power to order recalls

Where the drug regulatory department, after investigation and assessment, believes that there are defects, the medical device manufacturing enterprise shall recall the medical device without recalling it, and shall order the medical device manufacturing enterprise to recall the medical device.

When necessary, the drug regulatory authority shall require the medical device manufacturing enterprise, operating enterprise, and user unit to immediately suspend sales or use and inform the user to immediately suspend the use of the medical device.

The pharmaceutical supervisory and administrative department shall order the recall decision, and shall send the notification of the recall order to the domestic agent of the medical device manufacturer or the imported medical device manufacturer. After the medical device manufacturing enterprise receives the order for recall, it shall notify the medical device operating enterprise and user unit or notify the user in accordance with the regulations, formulate and submit the recall plan, and organize the implementation.

Was ordered to recall "heavily punished"

If there are defects in medical devices, companies that have voluntarily recalled them can “slow down”. However, if it violates the provisions of the Measures and discovers that there are potential safety hazards in medical devices that are not actively recalled, they will be “heavierly punished” if they are ordered to recall by the drug regulatory authority.

According to the regulations, the drug regulatory authority confirms that medical device manufacturers have violated laws, regulations, and regulations that caused defects in listed medical devices. According to law, they should be given administrative penalties. However, if an enterprise has already taken recall measures to actively eliminate or mitigate the harmful consequences, it shall be The provisions of the Administrative Punishment Act shall be lighter or mitigate the punishment; if the illegal act is minor and correct in a timely manner and does not cause any harmful consequences, it shall not be punished.

If a medical device manufacturing company violates the provisions of these Measures and discovers that the medical device has a defect and does not voluntarily recall the medical device, it shall be ordered to recall the medical device and shall be subject to a fine of 3 times the amount of the value of the medical device. If serious consequences are caused, the original certificate shall be issued. The department revoked the medical device product registration certificate and revoked the "Medical Device Manufacturing Enterprise License."

Medical device manufacturing companies that refuse to recall medical devices shall be subject to a recall of three times the amount of the value of the medical device. If serious consequences are caused, the original license issuing department will revoke the registration certificate for medical device products until the Medical Device Manufacturing Enterprise License is revoked. .

If the recalled medical device causes damage to the patient, the patient may request compensation from the manufacturer, or request compensation from the medical device operating enterprise or user unit. If a patient requests compensation from a medical device operating company or user unit, the medical device operating company or the unit using it shall be entitled to claim compensation from the responsible manufacturer.