The review authorities shall not be confined to the minority. Instead, a new review mode of “classification, branching and staging” should be established.
Words like medical masks, nuclear magnetism, CT, vascular stent and heat valve may be familiar to patients. However, they are collectively known as medical devices which play an increasingly important role in the prevention, diagnosis and treatment of diseases. In recent years, the medical device industry in China is flourishing thanks to the strong support of national policies. The average annual growth rate of production value reaches 20%, the manufacturing enterprises increases to 15,000 and annual various applications for registration are 12,000.
If the medical device industry is considered as “foreground”, the review of medical devices may be considered as “background”. The rapid development of the foreground needs strong support from the background. In recent years, the medical device review has achieved significant development. With reviews continuously increased, more than 10,000 technical reviews had been completed in 2016, making a basic balance between the imported and exported product review items. Despite the satisfying achievements, the weakness deserves attention. There are still many risks facing the medical device review, which demand prompt solutions. Over the past two years, we have reformed the review system and made great efforts to eliminate the risks.
Optimize the review procedures. Previous review modes relied mainly on a single reviewer who was responsible for the whole review. As the technology develops dramatically and the division of labor based on specialization is more detailed, simply relying on personal professional knowledge results in an increasingly higher risk for review quality, which fails to guarantee the safety and efficiency of products. Therefore, it is not applicable to the practical review need. Accordingly, optimizing or reconstituting the review procedures is the best choice. Only when new systems or mechanisms such as project team review system, pre-registration system verification mechanism, technology committee decision-making mechanism and review quality supervision system are introduced, can the management of the review process be enhanced and the review quality and efficiency be improved. Based on two-year reform experience of Center for Medical Device Evaluation, the introduction of these new systems or mechanisms has significantly improved the scientific review level.
Prevent and control the risk of administrative corruption. It turns out that a larger discretionary power usually denotes a higher risk against administrative corruption. Preventing the closure of the reviewers who possess the ultimate power not only relates to individual honesty and self-discipline, but also to the safety and effectiveness of public devices. To achieve power balance, the review right can never be confined to the minority. Instead, a new review mode of “classification, branching and staging” should be established. In light of the difficulty and complexity, the review tasks will be classified and distributed to different paths to review different resources. The major items will be discussed and determined together, thus completely changing the previous review mode with one single reviewer. In the meantime, a disclosure system shall be established to make the reviewer information, review progress and review reports available online. In this way, the review is open to all and subject to social supervision at any time, thus reducing the risk of administrative corruption.
Improve the review quality. A supervision mechanism involving document review, internal audit and management review is in urgent need to ensure an all-around quality control of technical reviews and relevant supporting processes.
It shall be noted that the reform of the medical device review system is still in progress and requires more efforts.
(The author is the director of the CFDA Medical Device Evaluation Center)
Words like medical masks, nuclear magnetism, CT, vascular stent and heat valve may be familiar to patients. However, they are collectively known as medical devices which play an increasingly important role in the prevention, diagnosis and treatment of diseases. In recent years, the medical device industry in China is flourishing thanks to the strong support of national policies. The average annual growth rate of production value reaches 20%, the manufacturing enterprises increases to 15,000 and annual various applications for registration are 12,000.
If the medical device industry is considered as “foreground”, the review of medical devices may be considered as “background”. The rapid development of the foreground needs strong support from the background. In recent years, the medical device review has achieved significant development. With reviews continuously increased, more than 10,000 technical reviews had been completed in 2016, making a basic balance between the imported and exported product review items. Despite the satisfying achievements, the weakness deserves attention. There are still many risks facing the medical device review, which demand prompt solutions. Over the past two years, we have reformed the review system and made great efforts to eliminate the risks.
Optimize the review procedures. Previous review modes relied mainly on a single reviewer who was responsible for the whole review. As the technology develops dramatically and the division of labor based on specialization is more detailed, simply relying on personal professional knowledge results in an increasingly higher risk for review quality, which fails to guarantee the safety and efficiency of products. Therefore, it is not applicable to the practical review need. Accordingly, optimizing or reconstituting the review procedures is the best choice. Only when new systems or mechanisms such as project team review system, pre-registration system verification mechanism, technology committee decision-making mechanism and review quality supervision system are introduced, can the management of the review process be enhanced and the review quality and efficiency be improved. Based on two-year reform experience of Center for Medical Device Evaluation, the introduction of these new systems or mechanisms has significantly improved the scientific review level.
Prevent and control the risk of administrative corruption. It turns out that a larger discretionary power usually denotes a higher risk against administrative corruption. Preventing the closure of the reviewers who possess the ultimate power not only relates to individual honesty and self-discipline, but also to the safety and effectiveness of public devices. To achieve power balance, the review right can never be confined to the minority. Instead, a new review mode of “classification, branching and staging” should be established. In light of the difficulty and complexity, the review tasks will be classified and distributed to different paths to review different resources. The major items will be discussed and determined together, thus completely changing the previous review mode with one single reviewer. In the meantime, a disclosure system shall be established to make the reviewer information, review progress and review reports available online. In this way, the review is open to all and subject to social supervision at any time, thus reducing the risk of administrative corruption.
Improve the review quality. A supervision mechanism involving document review, internal audit and management review is in urgent need to ensure an all-around quality control of technical reviews and relevant supporting processes.
It shall be noted that the reform of the medical device review system is still in progress and requires more efforts.
(The author is the director of the CFDA Medical Device Evaluation Center)