Status and Prospect of Sterilization Packaging of Medical Devices in China

According to estimates, in 2003 the global market capacity is 1.65 billion US dollars, the North American market is the world's largest sterile packaging market, accounting for just half: 800 million US dollars; Europe and Asia is almost equally divided, each about 20% Market share, South America accounted for the remaining 8%. Africa is unable to reflect market share because of the weak medical industry.

And then we look domestic medical device packaging industry. According to Bemis (America's best-known medical device packaging company), the head of China, Mr. Jiao Fei’s statistical analysis of medical equipment industry associations, estimated that the current domestic market capacity should be about 0.5 billion US dollars, based on the author of the domestic medical device packaging field of well-known suppliers in the annual sales, this is a slightly underestimated figure.

 From a large historical environment, perhaps the professional packaging industry as a new industry will lead to the professionals in the country that has a certain scarcity, leading to professional-free professionally design product packaging. However, the industry does not attach importance to the product packaging or do not have this concept which is also an outstanding problem leading to product packaging that is an indisputable fact. I write one of the important reasons in this article is to remind the majority of medical equipment industry colleagues: different medical device products in the ordinary industrial products, because it is a matter of vital concern, so product packaging sloppy must make the product packaging in line with the relevant national laws and regulations standards to ensure product quality and continuous packaging stability in order to market. Do not commit a heavy product R & D and production, not heavy product packaging design errors.

 Thus, in the existing domestic packaging industry system, the medical device packaging is ignored, a lot of packaging industry will be more familiar with the medical packaging, because the pharmaceutical packaging materials and methods and food packaging are very similar. But the medical device packaging and medical packaging are the two in the process and the material has a great gap between the concepts, so the current domestic packaging industry is very strange. The medical device industry, because of the industry independence, their product packaging requirements are stricter. From the perspective of the ancillary packaging, any ordinary industrial products are similar, which is the use of the most common cartons, cartons, plastic bags, trays and containers, but medical equipment products on the protection of this sub-packaging and retrospective of the requirements may be higher, so there will be more stringent flow of packaging testing standards to ensure that this point.

 Medical equipment packaging industry in the world-renowned companies to enter the Chinese market on the domestic medical device industry which should be a good thing, after all, we have to learn and copy the object (advanced products and its management model), because in this areas, we need to learn and progress too, in the country, except Europe, the United States leading companies, to a little technical content of the remaining enterprises in Taiwan. The Chinese mainland enterprises, such as the construction of Shanghai, Ningbo Xinhua, etc., are really only do simple ordinary breathable paper coating, printing and processing of such low-tech products. We are not afraid of backwardness, most afraid things we do not know. We know not to take action to make up for this backwardness, which is what we do in the domestic packaging technology personnel should be responsible for the most things.

Domestic manufacturers of medical equipment packaging products, advanced packaging materials and equipment to enter the domestic market for its product packaging to enhance the grade which provides a solid foundation, and thus export to Europe, the United States, Japan and other developed countries market permits certificate. But it also raises the question of the political nature of packaging, that is, exports of developed countries use good packaging products, and in the domestic market or other developing countries on the market selling products are sloppy, the most typical example is: exports to the United States, all need syringe bags of plastic bags, but the domestic market sales of more than 80% of the syringe is used ordinary LDPE bag packaging. The two packaging on efficiency and effectiveness of EO sterilization has a lot of gaps; some domestic product packaging may also use PVC film or plastic box, but in developed countries it is banned. Of course, this is out of consideration of product packaging costs leading to this difference.

Finally, medical device manufacturers also have to bear in mind that: the most expensive packaging costs are packaging failure, because the medical device products fault recovery system, the manufacturer of the product is responsible for the recovery and compensation for the resulting loss. This is a very serious problem that can lead to a serious loss of the manufacturer's reputation, or even bankruptcy. So if the product was asked to return because of packaging problems, it is a bit worth the candle.


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