The newly revised Medical Device Classification Catalog (hereinafter referred to as the "Classification Catalog") released by the State Food and Drug Administration was officially released on August 31, and its formal implementation date is 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 equipment enterprises at all levels?

Recently, leaders and experts from the Department of Medical Device Registration and Medical Device Management of the State Administration of Taxation and other departments conducted discussions and explanations on this series of issues at the "Training Catalog on Implementing the Policy for the Implementation of the New Catalog of Medical Devices and Implementation of Comprehensive Knowledge" .

Update the regulatory model

The revision of the "Classification Catalog" is a work that has "taken the lead and made its full appearance" and requires the active coordination and corresponding adjustment of various departments. Zhang Zhijun, deputy director of the China Institute for Food and Drug Control Research and the vice director of the Medical Device Management Center of the General Administration of Administration, said at the training session: "The adjustment of the" classified directory "will bring many new requirements and new changes, not only related to the registration of products, 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. In the future, after the release of "Catalog", it is expected that a professional group corresponding to 22 sub-directories will be established in the future. With the help of professional group experts, new products or products in doubt will be discussed and decided. 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. "It is estimated that technicians will be appointed as professional group secretaries from the Medical Device Standard Management Center to merge professional groups of similar products and gradually transition from late stage to full-time staff to undertake the secretariat work," Zhang Zhijun said.

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 "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.