Kits Go To Sea, "Threshold", Different Agents "Find Their Own Way" To Seize The Market.

Despite the outbreak of the new crown pneumonia outbreak in China, the Chinese reagent kits "get together" to sea, but the quality certification still exists in the "gray zone".

Recently, the news of Spain's new crown virus test kit bought from Shenzhen Yi Rui bio was questioned, and the news of "quality is not the same" was boiling. After many responses and clarification, the result remained unclear. The controversy over the launch of the kit has not yet been returned. The chaos under the certification outlet of the kit has also attracted wide attention.

In the evening of March 30th, the Ministry of Commerce and the General Administration of customs and the drug administration also issued a notice, which will require the relevant medical materials for export to obtain the relevant qualifications of the national drug regulatory authorities and meet the import country (regional) quality standards.

Agents are also playing an important role in the process of selling kits abroad, which is equivalent to detecting the "tentacles" of products arriving around the world. According to people's daily, the controversial kit was bought by the Spanish Ministry of health from its agents.

? ? ? A kit manufacturer sales person told the economic news reporters twenty-first Century that the detection of new crown virus may be a relatively short-term market, and seize the opportunity to seize the overseas market. Under the relatively hot market conditions, some manufacturers will release the agent, the first level, the two level agent conduction. After the supply agent in the domestic market, agents need to find their own way. "Sold overseas.

Certification level implies "mystery".

And why are there any quality problems in the case of involvement in the dispute and getting the reagent kit for overseas market entry certificates? To answer this question, we need to start with the threshold of market access.

Take the European Union as an example, before the entry of such diagnostic products into the EU market, CE certification is necessary. Since December 2003, all the in vitro diagnostic medical devices sold in the EU Member States must comply with the 98/79/EC in vitro diagnostic medical equipment directive to complete the compliance evaluation procedure and paste the CE label to be listed in the EU. If the domestic kit wants to obtain CE certification to export to the European Union, it must comply with the basic requirements and relevant provisions of this directive.

? ? ? EU CE certificate There are generally three kinds of "Declaration of conformity" issued by the enterprise independently, the "Certificate of compliance" issued by the third party Agency (intermediary or testing certification body), and the "EU standards compliance certificate" issued by the EU announcement Agency (Notified Body) (EC Attestation of of).

According to the risk characteristics of in vitro diagnostic medical devices, the European Union divides medical devices into four categories: list A (List A), list B (List B), self-test (Self-testing) and other (Other). The regulatory level decreases in turn, and the CE qualification certification procedures are implemented according to different standards. The diagnostic products of the new crown virus belong to the medical devices that perform the CE certification procedures according to the category of "other (Other)". The evaluation process of these products is "self declaration", that is, the manufacturers themselves test according to the instruction standard, submit the declaration materials and make a qualified declaration which conforms to the CE standard, and the certificate obtained is "compliance statement". That is to say, the market access threshold of the new crown virus diagnostic products in the EU is relatively low.

For high risk products, the EU stipulates that there must be a notice organ involved in its certification process. In twenty-first Century, the economic news reporter found that more than 20 European Union public announcement institutions have been able to issue certificates according to 98/79/EC's in vitro diagnostic medical equipment directive. However, most of the new crown virus detection kit manufacturers in China have CE certificates of compliance, which do not need to be issued by these institutions.

? ? ? Relatively relaxed standard It also lets many kits manufacturers "scramble" to declare that their products have obtained CE certificates, but the quality of products is really difficult to judge. However, in twenty-first Century March 30th, the economic report reporter telephoned some domestic agency CE certification service agencies. Many agencies said they could not provide agent authentication service for the new crown detection kit.

In addition to the European Union, other countries have different requirements for market access threshold.

Relatively speaking, the Emergency Use Authorization (EUA) needed for the new crown virus diagnostic products in the United States is not so easy to obtain. According to the website of the Food and Drug Administration, FDA, only the Chinese gene has been obtained EUA.

? ? ? ? In other countries, such as Japan, diagnostic reagents are classified as pharmaceuticals, and the responsible department is the Ministry of health and labour. They need to be subject to the relevant regulations of drug administration. When they enter customs, they need to submit a copy of the "pharmaceutical production and marketing license (production license or similar production record)" and "copies of the pharmaceutical production sales approval (or certification or record keeping)".

? ? ? An industry insider told the twenty-first Century economic report that at present, the market access threshold of Japan and Korea is relatively high, and products need to be registered locally before they can be sold. Therefore, dealers have certain resources in the locals and can make products enter the green channel.

Vendors rely on agents to seize the market.

For agents, the time window to seize the kit overseas market is equally important. In this context, the manufacturer of the kit only delivers the goods, and agents are exploring the market by themselves.

An agent is a business operation for the enterprise instead of buying up the product. The ownership of the goods represented is the manufacturer, not the merchant. Because businesses do not sell their products, but instead sell them on behalf of enterprises.

This new crown kit has a certain timeliness behind the hot sales of overseas market. If the manufacturer wants to get through the overseas market quickly, it must rely on agents to open the market.

A Southern China reagent kit agent told the twenty-first Century business reporter that the whole market is very hot now, but we are also worried that we can not get through the overseas channels and cause stockpiling. The new crown kit product is different from what we did in the past. At present, it may have some timeliness. If the epidemic situation is controlled by July, the sales volume will be limited, but the demand and distribution of overseas markets will become the key in March to July.

The enterprise side also liberalized the agent threshold to a certain extent on the sale of the kit, and the qualification of the agent is relatively loose.

A salesperson of a kit manufacturer also told the economic news reporters in twenty-first Century that at present, there are not many kits that are sold abroad, less than 20 thousand people. The reason for this is that, on the one hand, there is a shortage of goods, and now there is a list of nearly one million people, but the output of goods is still scheduled. On the other hand, it is necessary to get through the threshold of sales admittance. However, because the new crown epidemic situation may have some special time window, there is no so-called long-term cooperation. Other companies such as trading companies or third party companies come to say that they want to find kits and manufacturers, and they also supply the same products.

It is understood that some kits manufacturers' attitude is also to see who can seize this opportunity to see who can get the market. At present, the industry's initial judgement of the life cycle of the kit product or about half a year is not necessary for the manufacturer to do the sole agency, which, to a certain extent, has aggravated the possibility of market chaos.