Source: China Medical Devices Author: Sai Jinhua
 

Yesterday (June 7), the State Food and Drug Administration (CFDA) issued the Announcement on the Rectification of Business Activities in the Circulation of Medical Devices (No. 112 of 2016), requiring local drug regulatory systems to deal with violations in the circulation of medical devices Carry out centralized rectification of business activities.
 

It can be said that this is likely to be an unprecedented rectification of medical devices after the regulation of drug circulation.

 

First self-examination: 8 major deeds, 2 years of reverse examination!

 

The Food and Drug Administration requires that all medical device operating companies must first carry out self-inspection actions from June 1 to July 15, and whether the company has complete qualifications and standardized operations in the two years since June 2014., False materials, labels, instructions, record system and other eight aspects to carry out self-inspection.

 

Self-examination content	Specific requirements
Check qualification	Operating enterprises engaged in the wholesale business of medical devices sellNot qualifiedof the operating enterprise or user unit; the medical device operating enterprise fromNot qualifiedThe production and operation of enterprises to purchase medical devices.
Check specifications	changes in operating conditions,Not in conformityMedical DevicesStandard requirements for operation quality management, not in accordance with the provisions of the rectification; without authorization to change the business premises or warehouse address, expand the scope of business or set up a warehouse without authorization.
Check the material	ProvideFalse informationOr use other deceptive means to obtain the "Medical Device Business License"; fail to handle the filing or provide false information when filing; forge, alter, buy, sell, lease, or lend the "Medical Device Business License" or "Medical Device Business Record Certificate" ".
Check three categories	Engaging in Class III medical device business activities without permission, or "medical device business license" after the expiration of the validity period of the extension, still continue to engage in medical device business.
Check the registration certificate	OperationClass II and Class III medical devices that have not obtained a medical device registration certificateIn particular, domestic agents of imported medical devices operate unlicensed products.
Check the standard	Business does not meet mandatory standards or does not meet the requirements of a registered orMedical devices with technical requirements for the products filed by the company; operating medical devices without qualified documents, expired, invalid or eliminated.
Check labels and instructions	Operating medical devicesInstructions, labelsFailure to comply with the relevant provisions; Failure to transport and store medical devices in accordance with the instructions and labels of medical devices, especially failure to carry out full-chain cold chain management of medical devices that require low temperature and refrigerated storage.
Check the record system	Failure to establish and implement a medical device purchase inspection record system in accordance with regulations; operating enterprises engaged in the second and third types of medical device wholesale business and the third type of medical device retail business fail to establish and implement sales in accordance with regulationsRecord Systemof.

 

Post-inspection: publication of the list, severe punishment!
  

During the period of self-examination, those who can take the initiative to find problems and correct other violations of laws and regulations can be given a lighter or mitigated punishment according to law; if they fail to report when due, the list of enterprises will be disclosed to the public and listed as key inspection objects; those who refuse to report, falsely report and conceal reports, self-examination is not serious, and rectification is not in place,strictly and severely investigate and punish,Until the "Medical Device Business License" is revoked; if a crime is suspected, it shall be handed over to the public security organ; if a serious violation of the law and breach of trust, joint punishment will be implemented.

 

After the self-examination, the drug administration will also analyze the situation of enterprise self-examination and rectification, adopt the method of cross-examination in different places, and carry out supervision and inspection in a targeted and focused manner. These checks include:

 

First, there are many problems such as low level of daily management, chaotic purchase and sales channels, and frequent cases, and enterprises with few problems found in self-examination and ineffective rectification measures;

 

Two is engaged in the need for low-temperature, refrigerated medical equipment business enterprises;

 

Third, the domestic agents of imported medical devices should be the focus of inspection, and each key inspection enterprises to select a number of varieties,Carry out the upstream and downstream extension inspection of the flow direction and the authenticity of the bill.For cases across administrative regions, a thorough investigation should be conducted by combining case investigation with on-the-spot investigation. During the inspection, problems should be found effectively, problems should be dealt with decisively, and measures should be taken resolutely to punish illegal enterprises.

 

Meanwhile, the Food and Drug AdministrationEncouragementThe public conducts illegal acts of medical device business enterprises.ReportOnce verified, rewards will be given according to regulations.National unified reporting telephone number: 12331.

 

Drug circulation regulation let the industry wind crane bark, medical devices have been following in the footsteps

 

Before the nationwide centralized rectification of medical device business enterprises, as early as May 3 this year, the State Administration issued the announcement on rectifying illegal business activities in the field of drug circulation (No. 94 of 2016). A nationwide self-examination will be carried out on 10 major issues such as affiliation and ticket walking. By the end of May, the self-examination will be completed. From June 1 onwards, it will enter the key inspection stage of the drug administration.

 

During this period, the State Administration of Food and Drug, the State Administration of Taxation, the Ministry of Public Security and other joint operations to crack down on violations of law and discipline in the circulation field, and there have also been media reports that public security in some areas have arrested drug delivery people, set up cards to stop cars for inspection, and so on. In addition, the implementation of the two-vote system and the VAT reform is imminent,Certificate, ticket, account, goods, paymentThere must be a one-to-one correspondence, otherwise the lighter will be punished and the heavier will be arrested. This once caused the entire circulation field to bark and everyone to be in danger. So far, it has not been relieved.

 

Now, just one month from the start of drug circulation regulation, the storm of medical device regulation has officially come! On the basis of drug remediation experience, do medical devices give loose?

 

Large quantities of medical device operators will be out.

 

According to data from the Food and Drug Administration, as of November 2015, there were 186269 medical device operating enterprises (Class II and Class III) that implemented license management nationwide. There are 125197 enterprises operating Class II medical device products and 121984 enterprises operating Class III medical device products.

 

Wei Shaofeng, deputy secretary-general of the China Medical Materials Association, said that the total market volume of China's medical device industry itself is not large. According to the association's blue book data, the market size of the entire industry was just in its early 300 billion in 2015, and the entire industry has obtained medical device business licenses. There are 186000 companies, and the average medical device business scale of each company is very small. This is not what the market needs, nor what regulators need.

 

He believes that with the intensification of national rectification efforts, the two-vote system will eventually be implemented in the field of medical devices. Coupled with the impact of the business-to-business increase, ticket scalping, ticket passing, and affiliation will push the survival soil. In the next few years, A large number of medical device operating companies will be eliminated, and the total number will definitely drop significantly, even from 180000 to 30,000.
 

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Attachment: Announcement of the General Administration of the People's Republic of China on the Rectification of Business Behavior in the Field of Medical Device Circulation (No. 112 of 2016)
 

Released on June 07, 2016

 

In order to standardize the circulation order of medical devices and crack down on illegal business activities, the State Food and Drug Administration has decided to carry out centralized rectification of illegal business activities in the field of medical device circulation.

 

1. Since the date of this announcement, all companies engaged in the second and third types of medical device business shall conduct self-examination on whether the company has the following illegal acts:
 

(I) operating enterprises engaged in the wholesale business of medical devices are sold to unqualified operating enterprises or users; medical device operating enterprises purchase medical devices from unqualified production or operating enterprises.
 

(II) business conditions change, do not meet the requirements of medical device business quality management standards, and fail to carry out rectification in accordance with the provisions; unauthorized change of business premises or warehouse address, expansion of business scope or unauthorized establishment of warehouse.
 

Those who (III) provide false information or take other deceptive means to obtain the medical device business license; those who fail to apply for the record or provide false information when filing; those who forge, alter, buy, sell, lease or lend the medical device business license or the medical device business record certificate.

 

(IV) engage in the business activities of Class III medical devices without permission, or continue to engage in the business of medical devices without renewal in accordance with the law after the expiration of the validity period of the Medical Device Business License.

 

(V) operating the second and third types of medical devices that have not obtained the medical device registration certificate, especially those that import medical devices domestic agents operating unlicensed products.
 

(VI) operating medical devices that do not meet the mandatory standards or do not meet the technical requirements of registered or filed products; operating medical devices without qualified certification documents, expired, invalid, or eliminated.
 

The instructions and labels of the medical devices operated by the (VII) do not conform to the relevant provisions; the medical devices are not transported and stored in accordance with the requirements of the medical device instructions and labels, especially those that require low-temperature and refrigerated medical devices.

 

The (VIII) fails to establish and implement the medical device purchase inspection record system in accordance with the regulations; the operating enterprises engaged in the second and third types of medical device wholesale business and the third type of medical device retail business fail to establish and implement the sales record system in accordance with the regulations.
 

2. medical device business enterprises should conduct self-examination one by one against the above problems since June 1, 2014, describe in detail the methods, processes, medical devices and personnel involved in the existing problems, carefully formulate rectification measures and plans, form a self-examination and rectification report, and submit it to the local municipal food and drug regulatory department with districts before July 15, 2016.

 

The legal representative of the enterprise shall sign the report, affix the official seal, and make a commitment to the authenticity, completeness and rectification of the report.
 

3. medical device business enterprises can take the initiative to find problems before July 15, 2016, while correcting other violations of laws and regulations, they can be given a lighter or mitigated punishment according to law;
 

If the report is not due, the municipal food and drug regulatory department divided into districts shall disclose the list of enterprises to the public and list them as key inspection objects;

 

Those who refuse to report, falsely report and conceal the report, are not serious about self-examination, and the rectification is not in place, shall be strictly and severely investigated and punished, until the "Medical Device Business License" is revoked;
 

For the (V), (VI), (VII), or (VIII) acts of Article 1 of this announcement, if the circumstances are serious, in accordance with the Regulations on the Supervision and Administration of Medical Devices 63, 66, and 607. the relevant provisions of Article 68, revoke its "Medical Device Business License" and disclose it to the public;
 

If a crime is suspected, it shall be handed over to the public security organ; if a medical device business enterprise has serious illegal and dishonest behaviors, joint punishment shall be implemented in accordance with relevant regulations.
 

4. provincial food and drug regulatory departments to timely summary, careful analysis of the enterprise self-examination and rectification of the situation. Train inspectors in a unified manner, organize capable forces, adopt cross-inspection methods in different places, and implement supervision and inspection in a targeted and focused manner.
 

First, there are many problems such as low level of daily management, chaotic purchase and sales channels, and frequent cases, and enterprises with few problems found in self-examination and ineffective rectification measures;
 

Two is engaged in the need for low-temperature, refrigerated medical equipment business enterprises;
 

Third, domestic agents of imported medical devices should be taken as key inspection objects, and several varieties should be selected from each key inspection enterprise to carry out upstream and downstream extended inspection of flow direction and authenticity of bills.

 

For cases across administrative regions, a thorough investigation should be conducted by combining case investigation with on-the-spot investigation. During the inspection, problems should be found effectively, problems should be dealt with decisively, and measures should be taken resolutely to punish illegal enterprises. Before September 30, 2016, the rectification situation should be summarized and reported to the State Food and Drug Administration. The investigation and handling of specific cases shall be reported in a timely manner.

 

Food and drug regulatory departments at all levels in the 5. must attach great importance to the centralized rectification work, strengthen organization and leadership, arrange specialized agencies and personnel to implement regulatory responsibilities, strictly enforce work discipline, and severely crack down on illegal operations in the medical device circulation field in accordance with the law. Actively play the role of social supervision, encourage the public to report illegal activities of enterprises, and once verified, rewards will be given in accordance with regulations. National unified reporting telephone number: 12331.
 

6., the State Food and Drug Administration will inspect the centralized rectification work carried out by various localities and conduct spot checks on the self-examination and rectification of enterprises. Praise the units and individuals who have found many problems and dare to deal with them resolutely; if the centralized rectification work is not carried out effectively, they shall be notified and criticized until the relevant personnel are held accountable.
 

In view of the problems found in the centralized rectification, the State Food and Drug Administration will constantly improve the regulatory system, implement the main responsibility of enterprises, effectively standardize the circulation order of medical devices, and ensure the supply of medical devices and the use of equipment by the public.

 

It is hereby announced.

Food and Drug Administration

30 May 2016