Problems in Existing Domestic Regulations and Regulatory Practices

First, the imported medical device agent is unable to fully meet its obligations.

1. Some import agents do not have control over the flow of imported goods.

Some import agents do not grasp the flow of goods, the main reason is the following three points. First, although the current regulations provide for agents to represent overseas applicants or file-filer to carry out medical device registration or filing work, but does not restrict the import agent must be the import of the general distributor, in practice, some overseas production enterprises based on business needs, designated agents for China's imported medical devices general distributor. But there are also a large number of agents do not belong to the general distributor, some even do only agent filing or registration work, even dealers are not. Second, the relevant provisions of the Customs Law do not restrict the need to be the general dealer or agent to provide medical device registration certificate for verification. Therefore, the channels of imported medical equipment to the domestic, in addition to through the general distributor, there is also the possibility to bypass the general distributor, in a similar "parallel import" way from other channels to transfer into the country. Third, there are some smuggling into the country. All of the above circumstances make it impossible for agents to grasp the flow of goods, and also make it impossible to draw goods from the sampling process, 60% to 70% of all imported products according to the registration of the agent sampling.

2. Some agents are unable to fulfill their post-marketing management obligations.

The current regulations stipulate that import agents, in addition to the obligation to file or register, should also carry out or cooperate with a series of medical device adverse event monitoring, recall and other post-marketing management work. However, due to some agents can not grasp the flow of goods, can not carry out substantive adverse events, recalls and other obligations. Coupled with legal liability can not be effectively implemented, so that adverse event monitoring, recall and other obligations can not be properly fulfilled.

3. Some products after the problem can not find the responsibility of the main body.

After some product problems, there has been a situation in the country can not find the main body of product responsibility. The Consumer Rights and Interests Protection Law, the Tort Liability Law and other relevant laws and regulations provide for the relevant liability of producers, sellers and users, and the victims of medical device products may defend their rights and interests through medical institutions and operating companies. However, there are still many cases where they cannot directly find overseas production enterprises, cannot find domestic agents or have no compensation capacity, resulting in these defenders having to find only the regulatory authorities.

Second, China's obligation to the agent is less set, some cases can not directly take punitive measures against it.

The overseas production enterprises stipulated in the current regulations of our country shall designate domestic agents for the record and registration, as well as assist in the post-market management obligations. The Administrative Licensing Law provides that the applicant may entrust an agent to apply for an administrative license. The administrative counterpart of a specific administrative license is the applicant, not the agent. The principal-agent relationship between the overseas production enterprise and the domestic agent belongs to the civil and commercial category in essence. The General Rules of Civil Law express the idea of "authorization" to produce the right of agency more clearly in the creation of the principal agent. The power of attorney shall state the agency matters, permissions and periods. Therefore, unless laws and regulations directly set the obligation of the agent, the administrative organ can not require the agent to bear the direct administrative responsibility for the behavior of overseas production enterprises.

Third, although China has the right to supervise overseas production enterprises, but it is not the normal regulation.

In the theory of international law, the main principles of national jurisdiction are the principle of territorial jurisdiction, the principle of personal jurisdiction, the principle of protection of jurisdiction and the principle of universal jurisdiction, in which the territorial jurisdiction and the principle of personal jurisdiction are mainly, protective jurisdiction and universal jurisdiction are the extension of national jurisdiction in traditional international law. The development of extraterritorial rules on national jurisdictions is essentially a matter of state sovereignty.

In Our country, a large number of laws and regulations have formulated extraterritorially applicable rules, the medical device field is no exception, such as "providing false information or other deception to obtain medical device registration certificate, medical device production license, medical device business license, large-scale medical equipment configuration license, advertising approval documents and other licenses, by the original licensing department to revoke the license has been obtained, and a fine of more than 50,000 yuan and less than 100,000 yuan." No applications for medical device licensing submitted by the relevant responsible persons and units shall be accepted within 5 years. Such administrative penalty provisions do not exclude the application of overseas applicants and overseas production enterprises. The Regulations on the Administration of Foreign Inspection of Pharmaceutical Medical Devices also give the relevant law enforcement authority to the State Drug Administration.

However, in practice, the administrative penalty provisions apply to overseas applicants, overseas production enterprises in the case of very few. As can be found, in 2012, the CSRC for the first time imposed penalties for short-term transactions of foreign institutions, warned foreign Resorts and Ocean, and fined 100,000 yuan each. On October 31, 2017, the State Drug Administration issued the "Advance Notice of Administrative Penalties" and "Notice of Hearing" service notice, to the United States Techworld Corporation, Inc. in the declaration of imported medical devices "nasal cleaner" product registration, suspected of submitting a false FDA issued 510K documents to make the revocation of medical device registration certificate, confiscation of illegal income and fines of administrative penalties.

The reason why this kind of administrative penalty provision is adapted to the overseas applicant and the overseas production enterprise is less is that there are differences in the formulation of rules and the practice of extraterritorial application. Although a State may, in accordance with the definition and orientation of its own sovereign image and content of sovereignty, formulate rules on its extraterritorial application, as well as the relevant rules on what nature, extent and scope of its own jurisdiction, once domestic law is truly extraterritorially applied, it involves international relations between different States, and it must consider the timing and object of application. Since the 21st century, driven by the Sabans Act, the Federal Securities Act, the Patriot Act, the U.S. federal justice department has increasingly used long arms as a weapon to prosecute and punish foreign institutions and individuals, which are often triggered when foreign companies have established certain direct or indirect operating, contractual or commercial relationships with the United States that have a continuing or recurring characteristic. From the perspective of the international community, most countries are also cautious and restrained in such applications. Based on the national development interests and the international community relations, it is in line with china's current development interests to apply carefully.