Editor\’s note: our condoms usually used in drugstores, business super stores, convenience stores, hotels and vending machines can\’t be considered as ordinary commodities. They are second kinds of medical devices that are strictly supervised by the food and drug administration. So, does it need to be licensed to sell condoms by the food and drug department? The general manager of the network today Baixiao cat focused on the condom business ten years of Guangzhou Kangxiang Industrial Co., Linqiao Chen had an exclusive interview, to see what he says!We can usually see condoms often seen in drugstores, supermarkets, convenience stores, hotels, and vending machines. Don\’t think they are just ordinary commodities. They are second kinds of medical devices which are strictly supervised by the food and drug administration. So, does it need to be licensed to sell condoms by the food and drug department? This is also a big problem for the operators. Bai Xiao cat network reporter on this problem before the veteran and the condom industry to communicate, the information obtained is engaged in second types of medical equipment are needed to the food and drug administration departments for the record, but recently the relevant departments of the state is to amend the relevant regulations, condoms may be exempted from the business requirements for the record. If this policy is implemented, it will be a great benefit to the condom industry.The general manager focused on condom business ten years of Guangzhou Kangxiang Industrial Co., Chen Linqiao tells the related situation to the reporter, the following is the Baixiao cat network interview:Baixiao cat network: the business of condoms, some people say that the record, some people say do not need, what happened?Industry: Chen Linqiao Kangxiang condom pertains to the second types of medical equipment, food and drug administration department has ten years experience of implementing the policy of supervision of condoms in the production and circulation changes many times.Before 2005, the operation of condoms needs to be licensed or put on record for the second kinds of medical equipment in the Department of food and drug administration.In May 26, 2005, 239 issued the first batch of second categories of medical devices list which do not need to apply for the license of medical device business, and no longer needed to record condoms.In June 1, 2014, the most stringent regulation on the supervision and administration of medical devices began in the June 1, 2014. Condoms, thermometers, medical cotton swabs and respirators need to be put on record by the food and drug administration department.In October 31, 2017, the food and Drug Administration for urgent supervision in solving practical problems, proposed to amend the \”Regulations\” the supervision and administration of medical devices: thirtieth to thirty-fourth, and one paragraph is added as the second paragraph: \”management by routine management can ensure the safety and effectiveness of second types of medical equipment in the process of circulation, without filing.\” Business condoms may not need to be put on record!Bai Xiao cat network: on the implementation of the 2014 history of the most stringent \”medical equipment supervision and management regulations\” in the process, what is the effect of operators of condoms?Kangxiang industrial Chen Linqiao: when the implementation of the 2014 \”the supervision and administration of medical devices regulations\”, a great impact on the condom industry, the most prominent problem in the retail terminal near the retail link, but also sell some condoms to the food and drug administration departments for the record, and must establish a corresponding medical management of the quality management system and quality the management agency or personnel, which makes the majority of retail units from! Even if the retail terminal operators want to record, many business super stores, convenience stores, drugstores, and vending machines will be rejected because they are not businesses but individual businesses. As a result, no channels such as supermarkets, convenience stores, drugstores, vending machines, which have been registered, will face the situation that they can\’t sell condoms, and these channels are the closest to consumers.Bai Xiao cat network: some retail stores do not record or not because of a great impact on the sales office for the record, condoms, wholesale companies generally can do record, they should not be affected by what?Chen Linqiao: when most Kangxiang industrial pharmacies, supermarkets, they have stores, vending machine and other retail units can not achieve the record, even if there is a business enterprise record condoms wholesale will also have great influence! At the end of the condom because most wholesale enterprises downstream customers are pharmacies, supermarkets, they have stores, vending machine and other retail units, if not sold to them, goods can only be hit in their hands, if the sales to these customers, or violate the provisions of article fifty-fourth of the \”measures\” the supervision and management of medical equipment business and face penalties. Therefore, during this period, the record of the wholesale business condoms also received a great impact!Bai Xiao cat: This is not the network consumers have effect?Kangxiang industrial Chen: Yes, if Linqiao closest to the user, so Shang Chao stores, pharmacies, vending machine sales channels such as condoms cannot face. The overwhelming majority of consumers will also face the embarrassment of unavailability. Sexual behavior without protective measures poses a great potential risk to personal health (especially women). The influence of the general public is certainly great.Bai Xiao cat: network is because of these reasons, I heard you also to the State Food and Drug Administration reflects the situation, and exemption from condoms operating record comments and suggestions. Do you think the regulation of condoms should not be too strict?Kangxiang industrial Chen Linqiao: not should not be too strict, but should the public has! Should the source to affect the quality of the (manufacturer) to implement strict management; implementation of record management of brands / distributor; circulation (distribution and retail sectors) by conventional management can ensure its safety and effectiveness, suggestions on the exemption management filing requirements.Bai Xiao cat: I agree on the network production enterprise shall carry out strict management, because they affect the quality of the source, but the brands and the general agent for management and what are the benefits?Kangxiang industrial Linqiao brands: Chen and the general agent of condoms may have an indirect effect on the quality of the products. Brand excellent understanding of the market and based on customer demand, have certain innovation ability, will put forward suggestions on improving the technology of production enterprises and higher quality standards, so as to promote the progress of the industry; and the lack of competitiveness of the OEM or agent, usually the most is the price war, the price war is the consequence of forced manufacturing cheap products, fake and shoddy goods often from illegal OEM or agent. So the brand of condoms and the general agent should have a certain threshold!Bai Xiao cat network: I understand, on different aspects of the supervision should be strict is different!Chen: I hope this Linqiao Kangxiang industrial \”supervision and administration of medical devices regulations\” amendment can be included in the list of condoms without filing, if this policy is implemented, it will be a major positive condom industry!