Da Vinci won ” National Mech Registration license “! How to understand the “localization” layout of foreign-funded machinery enterprises

2023-06-27

On June 14, 2023, Intuitive Fosun’s “Thoracic and Abdominal Endoscopic Surgery Control System” appeared in the delivery information of medical device approval documents on the website of the National Drug Administration. Registration Certificate number “National Instrument Registration Licence 20233010800”.

“Nation” means the territory of China; “Mech” stands for medical machinery; “Licence” represents domestic medical devices.

This means that after Wego, Micro Port, Kangdo and Edge Med, the fifth approved domestic Laparoscopy robot is Da Vinci himself.

So, what is the “domestic” surgical robot, and what is the definition of “domestic”?

What are the differences in the “localization” products of Da Vinci that have been approved so far, and can they be regarded as domestic equipment?

How is the “localization” of multinational machinery enterprises realized? Why do foreign companies begin to increase their “localization” layout in China?

How to define “domestic” medical equipment?

-In terms of the definition of “imported product”:

According to the Measures for the Administration of Government Procurement of Imported Products, imported products refer to products that enter China through customs declaration and inspection, and are produced outside the customs territory.
That is to say, the main criteria for distinguishing whether it is “imported” are “customs border” and “place of origin”. This point is also mentioned in the procurement documents of many hospitals.

Therefore, for the medical equipment produced by foreign-funded machinery enterprises in China, it can also be counted as domestic and enjoy domestic treatment. In other words, the definition of “domestic” includes not only local brands, but also products produced in the country by multinational enterprises.

From the perspective of the medical device registration certificate:

The product registration certificate is the marketing license certificate of medical device products, and only medical device products successfully obtained the registration certificate can be legally sold in China.

Medical device registration certificate, imported and domestic will be directly reflected in the registration information, so the simplest way to identify domestic (domestic medical device registration) or imported (overseas medical device registration) is: look at the number prefix of the medical device registration certificate.

1) Domestic medical device registration certificate, prefix: National Instrument Registration license XXXXX, the first XX is the registration year;

2)Overseas medical device registration certificate of prefix is: National Instrument Registration Importation XXXXX, the first XX is registration year;

All medical device registration information can be found on the official website of the NMPA .

The number of Da Vinci’s original registration certificate information (as shown below), was “national instrument Import…” The name was “Endoscopic Surgery Control System”; Now it is “National instrument registration Licence…” The name is “Thoracic and Abdominal Endoscopic Surgery Control System”; Another class II certificate approved this year “Disposable endoscope needle” is “Shanghai Instrument Registration permit”.

Will “localized” medical devices be treated differently?

In recent years, the state has introduced a number of policies to encourage the innovation and research and development of domestic independent brands, and the requirements of restricting import procurement and encouraging the procurement of domestic equipment have also been put forward in various procurement documents.

However, we often see that some procurement projects clearly stipulate that only domestic equipment is purchased, and “imported” products are not allowed to bid, but from the final result, Philips, GE, Siemens and other foreign brands still achieve the winning bid.

In October 2021, the Ministry of Finance issued the Notice on Implementing the Relevant Policies on Equal Treatment of Domestic and Foreign Enterprises in Government Procurement Activities.

In government procurement activities, except for procurement items involving national security and state secrets, products produced in China by domestic and foreign-funded enterprises shall not be treated differently.

China is encouraging China end uses for more domestic products in latest years. Thus, more and more overseas manufacturers are planning localization in China. BradyKnows localization team has extensive experiences in facility establishment, audit, supplier evaluation, manufacturing, registration, and marketing in China. Pls feel free to let us know any questions on China entry via info@bradyknowsmedical.com

Article Source：Device Market；

Translated & edited ： Bradyknows