On May 9，the 2018 Annual Statistical Report on Drug Supervision was issued on the official website of the National Medical Products Administration， listing the classified information on the production，operation，complaint/report and case investigation/handling in the fields of drug, medical equipment and health care in China.

In conjunction with this regulatory report and 2017 data, SAIBAILAN conducted the following statistics and comparisons related to medical equipment.

2018 data reporting period: from December 1, 2017 to November 30, 2018

2017 data reporting period: from December 1, 2016 to November 30, 2017

Production license data

As of the end of November 2018, there had been 17,000 medical equipment manufacturers in China, increased by about 1,000 compared with the previous year. They can be divided as follows according to the product categories:

It can be seen that the number of manufacturers capable of producing Class I products increased the fastest, while the number of manufacturers capable of producing Class II and III products decreased.

Business license data

As of the end of November 2018, there had been 511,000 enterprises capable of operating Class II and III medical equipment, increased by about 100,000 compared with the previous year. Specific details are as follows:

According to the above data, the number of domestic enterprises with business licenses increased, compared with that in 2017.

Medical equipment registration data

According to 2018 data, there were 22,167 registrations of Class I domestic medical equipment, and 1,885 registrations (including those in Hong Kong, Macau and Taiwan) of Class I imported medical equipment (relevant data of 2017 are not disclosed, so the comparison data are not provided).

SAIBAILAN found that, in the reporting period, a number of registrations of medical equipment decreased compared with those in 2017, and some items increased a little.。

Complaint/report data

The number of complaints/reports, filed cases and settled cases increased, compared with those in 2017.

Case investigation/handling data

According to the above case investigation/handling data, the number of cases related to medical equipment continued to increase, the amount of fines increased by RMB 140 million, and 188 unlicensed enterprises have been banned from operation.

Comprehensive regulation in the reporting period

It can be seen that the national regulation has been intensified in the reporting period.

It should be pointed out that, in the statistical period of the report, the National Medical Products Administration issued the 2018 Special Regulation Plan for Crackdown of Illegal Operation and Use of Medical Equipment. Special regulation activities were carried throughout the country from May to November 2018. This was also one of the highlights determined in the national meeting on medical equipment regulation.

There are 5 work tasks in the special regulation:

(I) Rigorously inspect the unlicensed operation and online sales of medical equipment.

(II) Rigorously inspect the operation (online sales) and use of medical equipment without registration or filing certificates.

(III) Rigorously investigate the operation of products of high concern and large quantity, such as sodium hyaluronate for injection, condoms and contact lenses.

(IV) Inspect whether the operation enterprises of Class III medical equipment implement the Regulations on Quality Management of Medical Equipment Operation.

(V) Inspect the implementation of the Procedures for Quality Supervision and Management of Medical Equipment Use.

Compared with the previous activities, this special regulation activity of the National Medical Products Administration applied to nationwide medical equipment operation enterprises, instead of those engaged in the operation of Class II and III medical equipment.

However, the enterprises operating Class III medical equipment are still the focus. They were subjected to the flight inspection, cross inspection, and the like.

Focus on inspection of unlicensed operation

The regulation in the reporting period was also more targeted than before. It focuses on the unlicensed operation, and the operation and use of unlicensed medical equipment. As shown in the latest statistical report of 2018, 188 enterprises engaged in unlicensed operation of medical equipment were cleared out of the industry, and the 18,000 cases and fines of RMB 570 million were all caused by unlicensed medical equipment.

It is reported that the administrative punishment cases related to unlicensed medical equipment involved individuals, small-scale distributors, multinational corporations, domestic listed and leading enterprises, and also medical institutions at various levels across the country.

In addition, the Regulations on Online Sales Supervision of Medical Equipment took effect in the reporting period, stipulating that the enterprises and third-party platforms engaged in online sales of medical equipment must have the license or filed certificate and comply with the laws, regulations and specifications associated with medical equipment.

Seen from the current data, remarkable results have been achieved in offline and online activities, thereby purifying the medical equipment industry by elimination and promotion. This also indicates that the National Medical Products Administration will intensify the regulation on illegal operations in this industry.

Note:

Medical equipment production license: if an enterprise produces both Class I and Class III products, it is included in the Class I and III enterprises, respectively, but only deemed as one in the total number of enterprises.

Medical equipment operation license: if an enterprise operates both Class II and Class III products, it is included in Class II and III enterprises, respectively.

Source: National Medical Products Administration