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State Food and Drug Administration: will vigorously support the development of innovative medical de


Recently, according to the official website of the State Food and Drug Administration, the proposal of the NPC deputies was responded, indicating that it will strongly support the development of innovative medical devices.

Encourage medical device innovation industry

The State Drug Administration attaches great importance to encouraging the development of medical device innovation and development.

In 2014, the General Administration of Food and Drug Administration issued the “Special Approval Process for Innovative Medical Devices (Trial)”. In 2018, the State Drug Administration revised and issued the “Special Examination Procedure for Innovative Medical Devices”.

The program has set up a special approval channel for medical devices with Chinese invention patents, technically domestically pioneered, internationally leading, and with significant clinical application value.

For innovative medical devices that have been examined and approved in accordance with the procedures, the drug regulatory authorities and relevant technical agencies shall give priority to innovative medical devices in accordance with the principles of early intervention, special personnel, and scientific approval, and strengthen communication with applicants. .

The implementation of this program plays an active role in encouraging the research and innovation of medical devices, promoting the promotion and application of new medical device technologies, and promoting the development of the medical device industry.

In 2016, the former General Administration of Food and Drug Administration issued the “Approval Approval Procedure for Medical Devices” for medical devices, diagnosis or treatment of rare diseases, malignant tumors, elderly-specific and multiple diseases listed in the national science and technology major special projects or key research and development programs. Children's medical devices, as well as clinically urgently needed medical devices, are given priority approval to facilitate the listing of such products as soon as possible.

At present, the Guangdong Provincial Government is studying the construction ideas of technical support institutions for drug and medical device review and inspection in Dawan District of Guangdong, Hong Kong and Macao, and will actively support the innovation of institutional mechanisms that are conducive to medical device supervision, and promote the innovation and development of medical device industry in Guangdong, Hong Kong and Macao. .

Innovative medical device pricing

After the establishment of the Medical Security Bureau, the medical service price work is prepared in two steps:

The first is to find out the medical charges of the provinces in various provinces and update the national medical charges general catalogue. On this basis, the provinces shall formulate corresponding charging catalogues according to the actual conditions of the province;

The second is to speed up new technology access and related pricing work, thus forming a unified market. The provinces select new projects approved by the state according to their technical capabilities, thereby reducing the burden on medical device enterprises and promoting the promotion of innovative medical devices in the market.

Prior to the completion of the above work, the provinces were still implemented in accordance with the current system, and the province's fee list and charging standards for relevant medical service projects were formulated.

After the establishment of the Medical Security Bureau, it will assume the functions of formulating bidding procurement policies for pharmaceuticals and medical consumables.

For new products that are approved for sale, including innovative medical devices, the following two policies will be introduced:

First, refine the record-keeping procurement system for provincial-level centralized bidding and procurement platform for medical devices, and limit the filing period;

The second is to form a national medical device price linkage mechanism, and gradually realize “one province to hang the network, the country can be plucked”, minimize the bidding and sales costs of enterprises, and remove obstacles for the successful listing of innovative medical devices.

About medical device medical insurance catalogue

The Ministry of Labor and Social Security and other ministries and commissions issued the "Notice on Printing and Distributing the Opinions on the Management of Medical Expenses for Urban Workers' Basic Medical Insurance, the Scope of Medical Service Facilities and the Payment Standards" (Laoshe Ministry issued [1999] No. 22), which clarified the national basic medical insurance. The scope of the medical treatment program stipulates various medical technology labor service items that are not paid for medical insurance and part of the payment, and diagnosis and treatment items using medical instruments, equipment and medical materials.

On this basis, according to the actual situation of medical technology development and basic operation, the provinces have adopted the exclusion method or the admission method to determine the scope of the basic medical insurance treatment and treatment projects in the province.

In accordance with the institutional positioning of ensuring the basic medical needs of insured persons, limited by the level of economic development and fund-raising ability, the basic medical insurance fund cannot cover all medical services currently used in clinical practice, and can only pay for clinical necessity, safety and effectiveness, and appropriate cost. Diagnostics, examinations, treatments, etc.

Some special needs, non-therapeutic, ineffective curative, clinical research, preventive care and expensive clinical diagnosis, examination and treatment projects are still difficult to incorporate.

In the next step, the Medical and Health Protection Bureau will further improve its policy measures and gradually improve the level of medical equipment protection.