The State Council issued: Medical equipment industry, screening key enterprises supervision!

Recently, the State Council issued the Guidance of the State Council on Strengthening and Standardizing The Supervision during and after the Event (hereinafter referred to as the Guidance), indicating that we should improve the quality of life of the people who are directly involved in...

When the way of supervision is more and more scientific, non-compliance or playing the edge of the pressure on enterprises will be more and more.

Focus on supervision of medical devices

The State Council recently issued the Guidance on Strengthening and Standardizing Ongoing and post-event supervision (hereinafter referred to as the Guidance), saying that key supervision should be carried out in accordance with the law and regulations in all areas directly related to people's lives and health and other special key areas.

Among them, it is required to establish and improve the traceability system based on product code management for key products such as medical devices and drugs, and form an information chain in which the source can be traced, the destination can be traced and the responsibility can be investigated.

The guidelines also stress that local governments at all levels may, in light of regional and industrial risk characteristics, explore the establishment of a list of key supervision items, strictly control the number of key supervision items, standardize key supervision procedures, screen and identify key production and business units under supervision, and implement follow-up supervision and direct guidance.

The establishment of traceability system is an urgent matter for the enterprises

To strengthen the ongoing and post-event supervision of the medical device industry, the unique identification of medical devices is the key, because it runs through the whole 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 hotspot in the field of international medical device regulation.

In 2013, the International Forum of Medical Device Regulators issued guidelines on the Unique identification System for medical devices. In the same year, the United States issued regulations on the unique identification system for medical devices, requiring the full implementation of the unique identification system for medical devices within 7 years.

In 2017, eu legislation required the implementation of unique labeling of medical devices. Japan, Australia, Argentina and other countries have also carried out relevant work, and the global work on unique labeling of medical devices has been advancing continuously.

From 2012, when the 12th Five-Year National Drug Safety Plan was issued by the State Council of China, it was required to "start the national unified coding of high-risk medical devices". Until 2019, it finally entered the substantive stage.

The STATE Food and Drug Administration said that, from the perspective of industry, the use of unique identification can help improve the level of information management of medical device manufacturers, establish product traceability system, improve enterprise management efficiency, and boost the high-quality development of the medical device industry.

In fact, from the perspective of mechanical enterprises, facing the attack of the unique identification of medical devices, how to improve the level of information management and establish product traceability system within the specified time is an urgent issue 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, indicating that 116 enterprises including Medtronic and Stryker and 108 medical institutions have been included in the training list, and the training has been completed and the pilot work has begun.

On September 17, the State Administration of Food and Drug Administration (SFDA) issued the Circular on Matters Concerning the Implementation of the First Batch of Unique Identification of Medical Devices (Draft for Comments), and selected some high-risk medical devices such as active and passive implants as the first batch of implementation.

As of August 1, 2020, medical devices manufactured shall have the unique label of medical devices. As a result, devices that are not uniquely identified, or that do not upload relevant data to a uniquely identified database, may not be available for sale.

In this regard, the enterprises that enter into the pilot are undoubtedly in the forefront of the industry, and a large number of other enterprises need to improve the level of information management in less than a year to establish the traceability system of equipment, which has undoubtedly become a top priority.

GMP certification of medical devices is subject to change

If the unique labeling of medical devices is the supervision mode that runs through the prior, during and after the event, then the GMP certification of medical devices is the supervision mode that focuses on the event. People in the industry once said that supervision of post-production is often not as effective as supervision of in-process production.

In 2007, the State Administration of Food and Drug Administration selected 51 sterile and implantable medical device manufacturers to carry out the pilot implementation of GMP related standards, and finally 39 enterprises passed the certification once.

At the end of 2009, the State Administration of Food and Drug Administration (CFDA) formally promulgated the "Standards for Quality Management of Medical Device Production (Trial)", which requires that it be implemented from January 1, 2011, and that the enterprises of the mechanical equipment have only one year for transitional rectification. Companies involved in the GMP pilot said it cost more than 1 million yuan to install a separate air conditioner and filtration system for the quality control area.

In 2014, the State Administration of Food and Drug Administration issued the Circular on Matters concerning the Implementation of Quality Management Standards for The Production of Medical Devices, which clearly stipulated that all medical device manufacturers should meet the requirements of the standards by January 1, 2018.

Some people call this time point the "life and death line" of medical device manufacturers, which shows that the implementation of MEDICAL device GMP has a decisive impact on the development of production enterprises.

Up to now, the GMP certification of medical devices has been passed for nearly ten years, but the GMP certification of drugs, which was born ten years earlier than the GMP certification of medical devices, 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 adopt the revised Drug Administration Law of the People's Republic of China. Cypress blue learned from authoritative sources that the cancellation of GMP certification will be checked together with production license and business license in the future, and relevant departments can check the implementation of GMP at any time, which makes the requirements for enterprises more strict.

Analysis according to the personage inside course of study, cancel the GMP certification, on the one hand, because the certification as authorities after endorsement for a company, and did not put the blame to the enterprise, on the other hand, due to the implementation of the marketing authorisation holder system, if you execute GMP certification, so quality management responsibility is still on the manufacturer, will weaken the responsibility of the marketing authorisation holder.

Meanwhile, on August 1 this year, the SFDA issued a notice on expanding the pilot work of medical Device Registration system, extending the pilot work to 21 regions, including Beijing, Tianjin, Hebei and Liaoning.

The principle of medical device registrant system and drug marketing license holder system is basically similar. I wonder whether the MEDICAL device GMP certification, which has been in operation for nearly ten years, will also face similar problems with drugs. Finally, the dynamic daily flight inspection will enable the equipment enterprises to fulfill their responsibilities.