Imported medical devices will be increasingly restricted!

In recent days, the Guangdong Provincial Drug Administration has issued the “Interim Regulations (Draft) on the Management of Urgently Needed Clinical Imported Drugs and Medical Devices in the Guangdong-Hong Kong-Macao Greater Bay Area of Guangdong Province (Draft)” to solicit public opinions. Even if it is clinically urgently needed, there are only three special circumstances that can choose to import.

Ⅰ. Only those products that are not available in China and cannot be replaced can choose to import.

The draft imposes clear restrictions on the importation of urgently needed clinical medical devices:
The imported urgent needed clinical medical devices shall be the medical devices that have been purchased and used by public hospitals in Hong Kong and Macao, are urgently needed in clinical use, have advanced clinical application, have not been approved and registered in the mainland of China, and cannot be replaced by the registered products (hereinafter referred to as “urgent medical devices”).

Ⅱ.After the application is submitted, it is subject to expert verification and is valid for only one year

If a designated medical institution applies for the import of  urgent medical devices, it shall, as required, submit an application to the Guangdong Provincial Drug Administration.
The Guangdong Provincial Drug Administration and the Guangdong Provincial Health Commission jointly set up a database of evaluation experts to evaluate and examine the advanced requirements put forward by designated medical institutions, such as whether the medical devices to be imported are clinically urgent and have no other means of treatment, and whether the domestic listed products can achieve the same therapeutic effect.

The evaluation and analysis of clinical urgency includes: whether it is clinically urgent and there is no description of other means of treatment, whether the domestic listed products can achieve the same therapeutic effect, the expected improved efficacy, the ability of medical institutions to use devices, and so on.

Safety assessment analysis includes: clinical use review, adverse events overview,  risk assessment and so on.

After accepting the application for the import of urgent  medical devices submitted by the designated medical institution, the Guangdong Provincial Drug Administration shall, within 20 working days, make an administrative decision on whether or not to grant import.

If an application is approved, the approval document shall be issued, and the approval document shall be valid for one year; if an application is not approved, a notice of disapproval shall be issued and the reasons shall be given.

Ⅲ.Once the product is recalled abroad, it must also be suspended in the mainland of China.

The Draft clearly states that if the urgent medical devices is required to be recalled abroad , the designated medical institution shall immediately stop the use  and notify the entrusted operating enterprise; the entrusted operating enterprise shall immediately stop the distribution and recall the distributed  medical devices.Where there is evidence that urgent medical devices may endanger human health and life safety, it should be recalled but not recalled, the drug administration may order designated medical institutions and entrusted trading enterprises to recall product.

Ⅳ.Foreign companies are actively responding to China’s policy adjustments
In recent years, the Chinese government has continuously issued relevant policies to encourage and support domestic independent innovation and speed up the promotion of domestic substitution of imported products.If the products to be purchased by multiple provinces and cities has domestic similar substitute products or the quantity of imported products of the same kind purchased meets the corresponding requirements, in principle, the imported products shall not be purchased.Even if it is allowed to choose imported products, it must be the medical equipment that is “just needed and urgently needed”, and it must not be used to restrict domestic medical equipment from participating in competition.

Of course, we also see that foreign companies are also actively responding to China’s policy adjustments in recent years, establishing R&D or production bases in China, and quickly promoting the localization of imported brands into strategies.The China’s policy orientation is to provide an open and fair market competition environment for companies that have really invested heavily in research and development and have launched high-quality products.

For  more information about China’s policy on medical device registration ，please contact：info@inspirativemde.com