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The State Council issued a document: the medical machinery industry, screening key enterprises for s


As the regulatory approach becomes more and more scientific, the pressure on the non-compliant or squashing machinery is growing.

Key supervision of medical devices

Recently, the State Council issued the "Guiding Opinions of the State Council on Strengthening and Regulating Post-event Supervision" (hereinafter referred to as "Guiding Opinions"), stating that it is necessary to implement key coverage of full coverage in accordance with laws and regulations in special key areas directly related to people's life and health. .

Among them, it is required to establish a sound traceability system based on product code management for key products such as medical devices and medicines, and form an information chain with sources that can be traced, traceable, and accountable.

In addition, the "Guidance Opinions" also emphasize that local governments at all levels can explore the establishment of key regulatory checklist systems based on regional and industry risk characteristics, strictly control the number of key regulatory matters, standardize key regulatory procedures, and screen and identify key regulatory production and management units. Track supervision and direct guidance.

Establishing a traceability system is an urgent task for the armed enterprises

Strengthening the post-event supervision of the medical device industry, the unique identification of medical devices is the key, because it runs through the entire upstream and downstream industry chain, and is an important method to change the status quo of industry supervision.

The unique identification of medical devices has always been the focus and hot spot in the field of international medical device supervision.

In 2013, the International Medical Device Regulatory Forum published a guide to the unique identification system for medical devices. In the same year, the United States issued the unique identification system for medical devices, requiring 7 years to fully implement the unique identification of medical devices.

In 2017, EU legislation required the implementation of the unique identification of medical devices, and Japan, Australia, Argentina and other countries have also carried out related work, and the global medical device unique identification work has been continuously promoted.

Starting from the issuance of the "Twelfth Five-Year National Drug Safety Plan" by the State Council in 2012, China has called for "starting the national unified coding work for high-risk medical devices", and it has finally entered the substantive stage until 2019.

According to the State Food and Drug Administration, from the perspective of industry, the use of unique identifiers can help improve the information management level of medical device manufacturers, establish a product traceability system, improve corporate management efficiency, and promote the high-quality development of the medical device industry.

In fact, from the perspective of the mechanical enterprise, in the face of the unique identification of medical devices, how to improve the information management level and establish a product traceability system within the specified time is an urgent problem to be considered and solved.

Moreover, on August 9, the State Food and Drug Administration issued the "Notice on the Training of the Pilot Work of the Unique Identification System for Medical Devices", showing that 116 companies and 108 medical institutions such as Medtronic and Stryker entered the training list and have now completed the training. Pilot.

On September 17, the State Food and Drug Administration issued the "Notice on Doing the First Batch of Implementation of the Unique Marking of Medical Devices (Consultation Draft)", selecting some high-risk risks such as active implants and passive implants. As the first batch of medical devices, medical devices

It is expressly required that from August 1, 2020, the medical devices produced should have the unique identification of medical devices. Therefore, devices that do not have a unique identifier at that time, or that do not upload relevant data to a uniquely identified database, may not be available for sale.

In this regard, the entry into the pilot of the machinery enterprises is undoubtedly in the forefront of the industry, the rest of the large number of machinery enterprises need to improve the level of information management in less than a year, the establishment of equipment traceability system, has undoubtedly become a top priority.

Medical device GMP certification, or change

If the unique identification of medical devices is through pre-, post-, and post-regulatory methods, then GMP certification for medical devices is focused on the regulatory approach. Some insiders have said that the supervision of after-the-fact products is often not as effective as the supervision of the production process.

In 2007, the State Food and Drug Administration selected 51 out of more than 1,100 sterile and implantable medical device manufacturers nationwide to carry out pilot implementation of GMP-related regulations, and finally 39 companies passed the certification.

At the end of 2009, the State Food and Drug Administration officially promulgated the "Quality Management Regulations for Medical Device Production (Trial)", requiring implementation from January 1, 2011, and only one year of transitional rectification period for machinery enterprises. Companies involved in the GMP pilot said that the air conditioning and filtration systems that were separately assembled for the quality control area cost more than $1 million.

In 2014, the State Food and Drug Administration issued the “Notice on the Implementation of Medical Device Production Quality Management Regulations”, clearly stipulating that by January 1, 2018, all medical device manufacturers must meet the requirements of the regulations.

Some people refer to this point of time as the "life and death line" of medical device manufacturers, which shows the decisive impact of the implementation of medical device GMP on the development of production enterprises.

So far, the GMP certification for medical devices has gone through nearly a decade, but the GMP certification for drugs that was born ten years before the medical device GMP is about to be cancelled.

On August 26 this year, the Twelfth Session of the Standing Committee of the 13th National People's Congress voted to approve the amendment of the Drug Administration Law of the People's Republic of China. Cypress Blue learned from authoritative sources: Confirmation of cancellation of GMP certification and certification, in the future will be checked together with production licenses and business licenses, and relevant departments can check the implementation of GMP at any time, the requirements of enterprises are more stringent.

According to industry analysts, the elimination of GMP certification, on the one hand, because the certification is like an authoritative department endorsing the enterprise, does not put the responsibility on the enterprise, on the other hand, due to the implementation of the system of the listing permit holder, if the implementation of GMP certification, then The quality management responsibilities are still on the manufacturer and will weaken the responsibilities of the listed license holders.

At the same time, on August 1 this year, the State Food and Drug Administration issued the Notice of the State Food and Drug Administration on Expanding the Pilot Program for the Medical Device Registrant System, expanding the pilot to 21 regions including Beijing, Tianjin, Hebei and Liaoning.

The principle of the medical device registrant system and the drug listing permit holder system are basically similar. I wonder if the medical device GMP certification that has been running for nearly ten years will also face similar problems with drugs, and finally let the mechanical enterprises through dynamic daily flight inspection. Implement your own responsibilities.