新闻资讯

Adjustment of regulations and standards for medical packaging industry

Release Time:

2022-03-29

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 regulations on medical device management. The introduction of these new regulations will affect the medical device packaging materials industry. Development prospects have a certain impact. Although the new regulations issued by different countries and regions are slightly different, they all involve the compression resistance, impact resistance (break resistance), and sterile barrier performance of the outer packaging of medical device products. The device also stipulates the need for an outer packaging that is resistant to oxygen permeation and a waterproof packaging.

"International Forum of Medical Device Regulators" 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 proposed at an industry international conference held not long ago that a large global circulation market for medical device products has been formed. In order to strengthen the integration of international medical device supervision, it is necessary to target medical devices (including other Packaging materials) to establish a unified international standard, and the current priority is to revise the international industry standard formulated many years ago. The sterile barrier performance requirements of the old version of ISO13485 and the water resistance requirements, high temperature resistance and other special requirements for precision instrument products now seem to be outdated, and it is urgent to improve the standard.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 outer packaging have come out, and the voice of re-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, waterproof and moisture resistance, material ductility and other material requirements of the outer packaging of medical device products, and mandatory requirements for the outer packaging of medical devices Manufacturers 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 inevitably face higher quality requirements, and the development trend of related packaging material products will also be affected.