The release of the new "Classification Rules" shows that CFDA is trying to clear the source from the starting point of medical device supervision and promote the scientific supervision of medical devices.

 

• 1. classified management to purify the source of supervision

 

The classified management of medical devices is the basis of the whole process supervision system of medical devices in China, and it is also the source of medical device supervision. The types of new products developed are different, and the systems, procedures and management requirements faced by all aspects of the whole process of supervision are different.

 

If the same is the production activities of medical devices, the first type of medical devices shall be subject to production record management, and the second and third types of medical devices shall be subject to license management. Once the category is determined, the "treatment" of each link in the whole process of supervision is determined. Therefore, the scientific and rational classification of medical devices is particularly important.

 

The reason is that the classification rules are the basis of the classification directory, which is related to the accuracy of the classification directory. Classification rules guide the formation of classified catalogues and are the basic basis for the classification catalogue system to summarize different categories of products;

 

Second, the classification rules are related to the vital interests of relevant enterprises. After the classification of new medical device products is determined, relevant enterprises will carry out all follow-up activities according to the classification results, which has a direct impact on the production and operation behavior of enterprises.

 

In the practice of medical device product filing and registration, the correct classification is often the minimum requirement for smooth filing and registration. Before the implementation of the new "Regulations on the Supervision and Administration of Medical Devices" (hereinafter referred to as the new "Regulations"), due to the lack of unified regulations on the definition of product classification, the provincial medical device regulatory authorities essentially hold the leading power of product classification definition.

 

The biggest drawback of this decentralized exercise of product category recognition rights is the different perceptions of the degree of product risk and the different scales of classification.

 

Now, according to the provisions of Article 16 of the new regulations, for newly developed medical devices that have not been listed in the classified catalogue, the applicant can directly apply for product registration in accordance with the provisions on the registration of Class III medical devices, or judge the product category according to the classification rules and apply to CFDA for category confirmation before applying for registration or filing of the product.

 

In other words, in the future, the right to confirm the category of new products will be exercised centrally by CFDA, which has changed the limitation of multiple rights in the past and is conducive to promoting fair classification. This is a major progress in the classification management system of medical device products.

 

• Classification of 2. categories and implementation of risk management

 

The first paragraph of Article 4 of the new "Regulations" establishes the classified management system of medical devices in my country. This paragraph stipulates that the state implements classified management of medical devices according to the degree of risk. Therefore, classifying medical devices according to their risk level is the most basic logical starting point for medical device regulation, and risk management has become one of the core requirements for the full regulation of medical devices.

 

After a new product is developed, it is first necessary to confirm whether it belongs to a medical device, and then to determine which type of medical device it belongs. The key to answer these questions is to correctly and objectively identify the degree of risk of the product, and "the degree of risk of medical devices should be based on the intended purpose of the medical device, through structural characteristics, use of the form, use of the state, whether contact with the human body and other factors." It can be seen that the accuracy of the classification depends to a large extent on the identification of risks.

 

Since the "Medical Device Classification Catalog" formulated according to the original "Classification Rules" has long been unable to meet the needs of regulatory work, CFDA has significantly accelerated the classification and definition of medical device products in recent years.

 

• On August 22, 2012, CFDA issued a definition notice for 158 product management categories such as capsular bag expansion rings.

   

• On March 31, 2015, CFDA issued a notice on the classification and definition of 153 products such as stereotactic mammography devices.

   

• On May 18, CFDA issued a notice on the classification and definition of 172 products such as artificial blood vessel rings.

   

• On June 11, CFDA issued a notice on the classification and definition of 22 products such as constant temperature nucleic acid amplification detector.

 

These intensive product classification activities have not only promoted the progress of medical device classification, but also accumulated experience in medical device risk management. However, because these activities are carried out from time to time, and the results of the definition are "separately listed" in the form of a notice and take effect immediately, in the absence of a summary version of the previous classification definition, it is inevitable that the information will be scattered, which brings considerable difficulties to the application of the rules to enterprises.

 

• 3. dynamic adjustment to optimize device classification

 

Once the medical device product category is determined, should it be set in stone? The answer is no. According to the provisions of Article 4, paragraph 6 of the new regulations, CFDA should not only be responsible for formulating the classification rules and classification catalogue of medical devices, but also analyze and evaluate the risk changes of medical devices in a timely manner according to the production, operation and use of medical devices, and adjust the classification catalogue.

 

In other words, the category of the medical device should be dynamically adjusted. From the perspective of product risk, the basic requirement of medical device listing is that its risk can be controlled and accepted, but its risk is not stable.

 

When progress has been made in risk evaluation criteria, depth of scientific cognition, control methods, etc. to subvert the judgment of product risk, the management category of the product should be adjusted, either the third category can be adjusted to the second category, or the second category can be adjusted to the third category, so as to be able to go up and down.

 

In order to implement the requirements for the dynamic adjustment of medical device categories determined by the new "Regulations", the new "Classification Rules" stipulates in Article 9 that "the State Food and Drug Administration may organize the medical device classification expert committee to formulate and adjust the medical device classification catalog".

 

The modification of these contents has optimized and improved the classification management system of medical devices. Although it is necessary to make adjustments to the medical device classification catalogue, it is not easy to make the correct and appropriate adjustments.

 

It involves many factors such as society, economy, technology, and management. It is essentially a complex system engineering. There is an urgent need for a set of benign mechanisms to ensure the orderly progress of dynamic adjustments, and to achieve the adjustment of categories and catalogues. "People" can make the dynamic adjustment system implemented.

 

• 4. coordinated promotion, solid regulatory foundation

 

To promote the management of the source of medical device supervision in an orderly manner, it is not enough to rely on the new "classification rules". It is also necessary to form a joint force with the "medical device classification catalogue", "medical device naming rules" and "medical device coding rules" to coordinate and promote to consolidate the regulatory foundation.

 

The Catalogue of Medical Devices is the result of the application of the Classification Rules, and its legal status has been confirmed in the new Regulations. The "Medical Device Naming Rules" will stipulate the common names of medical device products to avoid the current phenomenon of random confusion in the naming of medical devices.

 

The "Medical Device Coding Rules" will make clear requirements for the coding method, composition, and use of medical devices, laying the foundation for the construction of a full-process traceability system for medical device products.

 

The above four complement each other and constitute an important basis for the source of medical device supervision. The Classification Rules guide the formulation of the Classification Catalogue of Medical Devices, and the application effect can be directly reflected in the contents of the catalogue.

 

The generic name regulated by the "Medical Device Naming Rules" should not only reflect the true attributes of the product, but also be conducive to the classification of the product.

 

In the formulation of the "Medical Device Coding Rules", first, the influence of the product generic name on the coding must be considered. The appropriate coding must correctly reflect the internal relationship between the product generic name and the coding. Second, the product category should be reflected in the medical device code, and the appropriate code must also be a code that is conducive to the identification and judgment of the product category.

 

• 5. scientific objectivity and avoid capricious power

 

In the practice of medical device classification management, the scientificity and accuracy of classification are the core requirements. In the past practice, the phenomenon of "low class high classification" or "high class low classification" often appeared, and even the same product was divided into different categories by different regulatory departments.

 

These anomalies are typical of the different scales of classification, which are both the evil result of the decentralized exercise of category recognition rights and the bitter fruit of the poor application of classification rules. Incorrect classification not only violates the objective cognition of human beings to the risk of medical devices, but also encourages the unhealthy trend of lazy government and power willfulness.

 

The "Classification Rules" are the objective basis and reference standard for the classification of medical devices. When applying, we should adhere to a scientific and objective attitude. In particular, we should not define low-class products artificially high as high-class products on the grounds of so-called strict management.

 

This is not only contrary to the scientific spirit of classification, but has been proved to be useless. The artificially improving the management category of medical device products has brought heavier regulatory pressure to the already overburdened regulatory authorities, which not only diluted the limited regulatory power, but also affected the regulatory performance.

 

At present, under the good situation that the right to determine the category of new products belongs to CFDA and the new "Classification Rules" is issued, it is more appropriate to take advantage of the wind and waves to update the "Medical Device Classification Catalog" as soon as possible, and introduce and implement the "Medical Device Naming Rules" and "Medical Device Coding Rules".

 

After the foundation of medical device supervision has been deeply consolidated, the work pressure of the follow-up supervision link will be gradually relieved and released, which will greatly benefit the consolidation and development of the whole process supervision mode of medical devices.

Source: China Medical Devices Author: Jiang Haihong