Fujian Kailong Medical Hygienic Material Co.Ltd

In recent years, the development of new anti-counterfeiting packaging materials for medical devices is in full swing. This is because the unique packaging is easier to be identified by users, which greatly reduces the opportunities for counterfeit products to compete for the market and users. Therefore, the development of novel anti-counterfeiting packaging materials is becoming a new hot spot in the international medical device industry. Aceptic Packaging Chapter / 02 As a considerable part of medical device products are close contact with human body (such as disposable syringes, catheters, etc.), the packaging materials of sterile medical devices and drugs are an important part of the medical packaging material market. In view of the serious environmental pollution in many countries, medical products that are in close contact with human body must be able to resist the erosion of environmental pollutants. According to the information recently disclosed by databridge consulting company, the global market sales of sterile packaging materials for medical (including drugs and medical devices) in 2017 was $6.975 billion, and that in 2018 was $8.780 billion. According to the company's forecast, by 2026, the total sales volume of medical sterile packaging materials market will reach more than 13 billion US dollars. Flexible packaging materials Chapter / 03 Flexible packaging materials have also grown rapidly in the past five years. According to databridge, flexible packaging materials include various plastic bags (made of PVC, PE, PP and HDPE), flexible bottles or other containers (processed with polyethylene terephthalate or polypropylene), foamed polystyrene sponge cushion materials, and paper, aluminum foil, roll plastic film (coated with adhesive) ）Material packaging supplies, etc. Among the above flexible packaging materials, about 70% of the flexible packaging materials are made of polyethylene (PE) and polypropylene (PP). PE and PP are cheap and have good processing performance. According to databridge, the United States alone consumed more than $30 million of flexible packaging materials in 2018, and the market share of the products increased rapidly. Regulation and standard adjustment Chapter / 04 In the past two years, many countries and regions in the world have adjusted the medical device management regulations. The EU and ASEAN have issued their own new medical device management regulations, which will have a certain impact on the development prospects of the medical device packaging material industry. Although the new laws and regulations issued by different countries and regions are slightly different, their contents are related to the compression resistance, impact resistance (rupture resistance) and aseptic barrier performance of the external packaging of medical devices. For some medical devices with special requirements, it is also required to have the outer packaging with anti oxygen penetration and waterproof packaging. "International medical device regulatory agency forum" is an international industry organization composed of the world's major medical device manufacturers and exporters. According to reports, the Secretary General of the agency pointed out at an industry international conference held not long ago that a large global circulation market for medical devices has been formed. In order to strengthen the integration of international medical device supervision, it is necessary to establish a unified international standard for medical devices (including their outer packaging materials). At present, the primary task is to revise the international industry formulated many years ago Standards. The performance requirements of aseptic barrier and waterproof, high temperature resistance and other special requirements of the old version of ISO13485 are out of date now, so it is urgent to improve the standard. In addition, with the continuous emergence of new technologies in recent years, a large number of special new materials suitable for the production of medical device packaging have come out, and the call for revising ISO13485 and iso11607 is rising. The Secretary General also pointed out that the new version of ISO13485 will make specific provisions on the microbial barrier, tear resistance, water and moisture penetration resistance, material ductility and other material requirements of the outer packaging of medical devices, and require manufacturers of medical device outer packaging to refer to the implementation. It can be expected that once the revision of ISO13485 and iso11607 is completed, the global medical device packaging material industry will face higher quality requirements, and the development trend of relevant packaging material products will also be affected.

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Do you know that you have to have the validation of aseptic retention period of medical device packaging!