Medical Device Industry Accelerated Integration

The State Food and Drug Administration held a press conference yesterday (March 17) and announced that it will start a 5-month-long special campaign for medical device “five rectifications” nationwide starting in mid-March to focus on rectifying false medical registration applications and illegal production. , illegal operations, exaggeration of publicity, the use of unlicensed products and other five kinds of behavior. Affected by industry news, the stock prices of listed companies have risen.

Why did the State Food and Drug Administration choose to crack down on high pressure at this time? Yan Jiangjun, spokesperson of the China Food and Drug Administration, frankly stated that, as far as the current situation is concerned, in general, the security situation of China's medical equipment is generally stable. However, due to the relatively late start of China's medical device industry development, the overall size of the industry is still relatively small, the industrial base is relatively weak, and some companies' violations of laws and regulations occur from time to time, and it is necessary to promptly launch severe actions to comply with market supervision.

In fact, in recent years, the domestic medical device industry has developed rapidly and the market capacity has continuously expanded, but the overall industrial structure is loose and concentrated on the low-end technology level.

A senior executive of a domestic listed medical device company admits to reporters that at present, domestic monitoring medical devices have developed better, especially in export business, but therapeutic medical devices are still shortcomings.

Against this background, many people in the industry regard this round of regulatory oversight as an industry advantage. It will accelerate the concentration of large companies and the industry.

In fact, the integration of the medical device industry began last year has been accelerated. The reporter learned that the State Food and Drug Administration has successively promulgated the "Regulations for the Classification of Medical Devices" (Revised Draft), "Special Approval Procedures for Innovative Medical Devices (Trial)", "Standards for the Management of Medical Device Operational Quality (Draft for Comment)" and 104 The medical device industry standard has achieved full coverage of all aspects of registration, innovation review, production, and distribution management of medical devices. On March 4 this year, officials of the State Food and Drug Administration revealed at a meeting of the representatives of the two members of the medical community that this year the document, regulations, and regulations for medical devices will be completely revised.

Jiang Feng, president of the China Medical Device Industry Association, also publicly pointed out earlier that with the introduction of the new policy, the trend of upgrading and integrating the medical device industry will be more rapid. At the same time, mergers and acquisitions in the medical device industry are also intensifying. Some time ago, Yueyang Medical just announced the acquisition of China Resources Late East. Hejia shares also announced recently that the company has suspended trading for the preparation of a major asset restructuring.

A number of institutions reported that in the next decade, the fields of medicines ranging from diagnosis, monitoring, treatment to drug delivery will open the era of intelligence, and the medical device industry will become more and more portable and intelligent. The future will be related to chronic diseases. Field, mid-to-high end import substitution and mobile smart medical extension.

Li Xiaoming analyzed that the medical device industry rectification has been carried out. The rectification is estimated to be a combination of “3·15” special actions and should not have a major impact on the industry structure. “The rise in share prices may still be related to investors’ medical device industry. Be optimistic about it."

Yan Jiangyi further disclosed that “After the five-month special medical device remediation campaign is completed, it does not mean that our remediation has ended. It can be said that the rectification campaign has been completed and our work is not closed. The State Food and Drug Administration will continue to maintain it. The high-pressure situation of cracking down on illegal acts of medical devices will continue to consolidate the results of our special actions, further promote the construction of laws and regulations, and improve the long-term mechanism for supervision."