Why Is It Taking One Year to Migrate to China’s New Medical Device Classification System?


The newly revised Medical Device Classification Catalog (hereinafter referred to as the “Classification Catalog”) released by China’s State Food and Drug Administration (CFDA) was officially released on August 31 this year but it won’t take into effect until August 1, 2018.

The implementation of a new policy or regulation usually requires a period of transition so that relevant departments, units and personnel can react and adjust. However, what is the purpose of such a long transition period since the publication of the “Catalog” nearly one year after its publication? What important work needs to be done during the transitional period? What should be paid attention to by regulators and medical device manufacturers at all levels?

1. Update the Regulatory Model

According to top-level CFDA officials, the revision of the “Classification Catalog” is a piece of work that has “taken the lead and made its full appearance” and requires the active coordination and corresponding adjustment of various departments. The adjustment of the new catalog will bring about many new requirements and new changes, involving not only product registrations and medical devices Production and operation of enterprises, as well as medical institutions and other units will be affected, while the regulatory requirements for medical devices also put forward new requirements.Therefore, after comprehensive consideration of the views of all parties, finally reached an agreement to determine the transitional period of nearly 1 year.

It is learned that during the transitional period, some regulatory work related to the classification of medical devices will undergo changes and adjustments. The main updates and changes will focus on three aspects: the classification of the review of the form of classification; the embodiment of the classification code; dynamic classification of medical device information management.

In the case of the classification examination, in the past, for some medical devices that needed to be classified and judged, the examination usually took the form of a unified meeting to discuss the products. After the release of the new catalog, it is expected that in the future, professional groups corresponding to 22 sub-directories will be set up alone to discuss the new products or products in question through the help of professional group experts. Due to the relative shortage of manpower at present, the deployment of personnel has not yet been fully implemented. The examination method during the transitional period will adopt a combination of old and new methods.

In terms of classification codes, according to the requirements of classification management reform, starting from August 1, 2018, the registration lists of medical device manufacturing licenses and medical device manufacturing products shall be classified into “original classification code classification code area “And” new classification classification code area “, reflecting the two categories and clearly identify the classification. General Administration of Medical Device Standards Management Center for the defined definition of medical device classification application, as of November 1, 2017 has been based on the 2002 version of the “classification” and the revised “classification” gives the old two sets of classification codes and product management categories . In the “catalog” after the official implementation, will be based only on the new catalog classification coding and product management categories.

Achieving the dynamic management of medical device classification information is another key task started during the transitional period, and the construction and improvement of the medical device classification database will continue in the future. After the release of the “Catalog”, the General Administration of Medical Equipment Standard Management Center plans to step up the construction and management of classified information systems, and adjust and publish classified catalogs through research and establishment of dynamic adjustment mechanisms and real-time risk analysis.

2. Focus on Category Adjustment

One of the characteristics of China’s medical equipment category is the third largest proportion of medical equipment, which is different from the developed countries in Europe and the United States. In this regard, Zhang Zhijun that this is related to the actual situation in our country and industry characteristics. “The classification and management reform of medical devices, on the one hand, hope to reduce the proportion of the third type of device, but also need to consider the level and ability of provincial review agencies.If a large number of third-class medical devices into the second category , Will be relatively weak technical review capabilities, staffing relatively inadequate review agencies under pressure, is not conducive to review and approval of scientific progress. “

It is reported that in the use of a variety of medical devices, the actual use of equipment, safety and other areas re-carding assessment, some of the instruments in the “classification” to adjust the management category. For example, a perfusion pump for radiofrequency ablation devices, commonly used in the “01 Active Surgical Instruments” sub-directory, to reduce the temperature in the ablation zone-to-patient contact, is less risky because it does not enter the body during surgery. “The management of its category from the third category adjusted to the second category.

The relevant staff of the Medical Device Registration Management Division said that the products in the “classification catalog” whose categories have been changed shall be treated as the first registration and continuation of registration, and the “Circular on the Implementation of the Newly Revised Catalog of Medical Device” promulgated by the SAIC at the same time. In the corresponding provisions, companies can according to their own actual reference. The product may need to be registered for the first time due to adjustment of the management category. If the registration certificate expires before the completion of the category conversion, the enterprise may apply to the original examination and approval department for the extension of the registration certificate of the original medical device, and the validity period shall not exceed August 31, 2019.

In addition, in the revision of the “Classification Catalog”, the SAIC Medical Device Standards Management Center has sorted out the catalogs of products not covered in the 2002 “Catalog”, and none of these products appear in the “Catalog”. If the original does not belong to the medical device products, in the “classification” is classified as medical devices, Medical Device Registration Division will organize the relevant agencies to study and deal with advice.

3. Clear Policy Timeliness

With the release of the “Categorized Catalog”, the effectiveness of some documents will be affected, and enterprises and regulatory review agencies can use the transition period to buffer and adapt.

At this training session, relevant personnel from the General Administration of Medical Device Registration Department listed some documents that were still valid and about to be abolished, and some documents that only played a role in the transitional period reminded the units concerned. As of August 1, 2018, “Notice on the release of the first category of medical device catalog” “on the implementation of the first category of medical equipment filing of matters related to notice” and after May 30, 2014 release of the first category Medical device classification of instruments defined documents and other documents still valid. However, after 1 August 2018, if the product management categories covered by these documents are not the same as the “Classification Catalog”, the product management category of the “Classification Catalog” shall prevail.

It is noteworthy that some documents and catalogs will be abolished after the transition period ends. With effect from 1 August 2018, except for the contents of IV diagnostic products and the first type of medical devices and the past classification of defined documents which do not define the classification of products according to the management of medical devices, the 2002 Catalog and the past Published medical device classification documents and content will be abolished.

According to the evaluation of experts in the industry, “classified catalogs” are more logical in structure and more professional in content. After implementation, they will bring higher efficiency and stronger guidance to the registration, review, approval and supervision of medical devices. The transitional period provides a buffer for regulatory change and the adjustment of various industrial sectors, helping the “classified directory” to be put on the ground smoothly and be effective.

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