In 2011, China's medical device industry made remarkable achievements in terms of regulation, industry upgrading, science and technology, and achieved new breakthroughs.
I. Regulations and standards become more complete
In 2011, the system construction of China's medical device regulations and standards was improved with considerable breakthroughs, the technical support system became more robust and effectiveness, and the safety and efficacy of medical devices were better guaranteed.
II. The implementation of medical device GMP
Medical Device Good Manufacturing Practice (Interim) (hereinafter referred to as the GMP) came into force as of January 1, 2011. The GMP requires that medical device manufacturing enterprises should establish a quality management system to maintain an effective operation. Shortly thereafter, the State Food and Drug Administration(SFDA) issued a notice requiring the manufacturers of sterile and implantable medical devices to take the lead in the implementation of the GMP.
III. Improve the industry standard
With advances in technology, the replacement cycle of medical devices was gradually shortened, and the requirements for product standards are increasingly high. China has more than 3000 kinds of medical device products, of which many standards need to be developed. In January 2011, the SFDA reviewed and approved 96 pieces of medical devices industry standards (including 34 mandatory industry standards and 62 recommended industry standards, which are to be implemented as of June 1, 2012) such as YY 0054-2010 Hemodialysis Equipment.
IV. Implementation of medical devices recall
Implementing the recall of defective medical devices is an international practice that plays an important role in the protection of the safe use of medical devices, indicating that medical device manufacturer is the first person responsible for product quality. From July 1, 2011, China formally implemented the Provisions for Medical Device Recall (Interim) (hereinafter referred to as the Provisions), which are comprised of 38 articles in six chapters, providing specific regulations to the administration of medical device recall from the aspects of the supervision system for medical device recall, the classification and categories of recall and the legal liabilities.
V. Strengthen the monitoring of adverse events
On September 21, 2011, the SFDA issued the Guide for Medical Device Adverse Event Monitoring (Interim) (hereinafter referred to as the Guide). The Guide raised detailed requirements on adverse events monitoring in medical device manufacturers, distributors and end-users, who are required to establish product traceability system.
Shortly afterwards (September 27 to 28), the National Medical Device Adverse Event Monitoring Onsite Meeting was held in Linyi, Shandong Province. This is the first medical device adverse event monitoring conference in the history. Relevant SFDA leaders stressed that we should fully understand the importance of medical device adverse event monitoring, learn from the advanced experience and ideas of the developed countries, and create a new environment for medical device adverse event monitoring.
VI. Health care reform gives birth to the boom of the medical device industry
The year of 2011 was crucial for deepening the new health care reform, China strengthened the construction of rural and urban community health service network, and the medical device industry became the first beneficiary. In 2011, China invested a total of 720 million yuan on rural emergency system, 500 million yuan on the training bases of general practitioners, and 100 million yuan on food safety risk monitoring system, all for the purchasing of related equipment, this ushered in a boom of the medical device industry.
VII. The policies boost scientific and technological innovations
In 2011, the pharmaceutical industry introduced a series of favorable policies, such as the Outline of the Development Plan for the National Pharmaceutical Distribution Industry (2011-2015) and the recently promulgated Twelfth Five-Year Plan For The Development Of Medical Science & Technology, and the forthcoming Twelfth Five-Year Plan for the Development of Bio-Pharmaceutical Industry, and the Special Plan on the Development of Science & technology in Medical Device Industry (2011 ~ 2015).
VIII. The promotion projects of diagnostic & treatment medical devices of traditional Chinese medicine
In view of the relatively slow development, low-tech products, slow upgrading, serious homogenization and other problems of TCM diagnostic & treatment medical devices, the State Administration of Traditional Chinese Medicine introduced in 2011 the Opinions on the Promotion of the Development of TCM Diagnostic and Treatment Medical Devices, and implemented the promotion projects of TCM diagnostic & treatment medical devices. In February 2011, the State Administration of Traditional Chinese Medicine started the second round of registration application for TCM diagnostic & treatment medical devices that need to be promoted, upgraded, transformed and developed in succession.
IX. The twelfth five-year plan for the development of medical science & technology
On November 21, 2011, the Twelfth Five-Year Plan for the Development of Medical Science & Technology came under the spotlight. The Plan clearly stated that centering upon major innovative drugs, medical devices and the TCM modernization, to develop strategic emerging bio-pharmaceutical industry. In the medical device R & D, research efforts shall be exerted on medium and high-end diagnostic & treatment medical devices with huge demands and wide range in clinical application, which are much-needed in the Chinese market; we will vigorously promote the development of cost-effective medical devices suitable for primary health care institutions; research and develop medical device products that are user-friendly, suitable for family or personal self-care and the rehabilitation or replacement of body functions; research and develop emergency rescue equipment.
X. The import & export trade as a major driving force
From January to November 2011, the import & export volume of China's medical devices reached $ 23.826 billion, an increase of 54.83% over the previous year, the number of enterprises engaged in import & export trade of medical devices has also witnessed a significant increase.
(Source: China Pharmaceutical News, December 28, 2011 January 4, 2012)