Project Description

Formerly BYD, BAIC, SAIC-GM Wuling to manufacture masks.

After the Rolls-Royce, Bentley and other cars want to switch to breathing machines?

With the spread of the epidemic overseas, the demand for medical equipment abroad has increased dramatically, with a particularly high demand for invasive ventilators. Countries have mobilized enterprises to transform the production of respirators, car companies have become the main force of transformation.

Given the current global epidemic, the recovery of Chinese enterprises and their strong productivity, countries have pinned their hopes on a larger share of the domestic market.

On March 11, China helped Italy solve a pressing problem by pledging to provide 1,000 lung breathing machines.

According to incomplete statistics, just ten days since March 19, China’s enterprises, while safeguarding domestic demand, the emergency provision of more than 1,700 invasive ventilators to foreign countries, reaching half of the domestic total provided so far this year.

Most of our country’s current exports from the ventilator industry are still dominated by households. The home ventilator is a simplified version of the medical mechanical ventilation equipment, a medical ventilator is less than a hundred thousand, more than a few hundred thousand(CNY), and the home general is also around ten thousand(CNY).

At present, there are 21 invasive ventilator manufacturers in China, 8 of which have obtained mandatory CE certification for their main products (about 2200 units per week), accounting for about one fifth of the global production capacity. At present, the order quantity is about 20,000 units, and a large number of international orders are being negotiated every day.

Not long ago, the shipping family received an order from Ms. Wu, about a total value of 1 million of ventilator equipment to be exported from Sichuan to Europe, consulting our export process.

Recently a number of customers have come to consult the ventilator export process, it is difficult not to replace the respirator mask, again to become a generation of buzzwords? The following are the answers to the following questions.

Classification

In terms of the medical device management category, non-invasive ventilators are classified as Class II medical devices and invasive ventilators are classified as Class III medical devices (Class III is a very high level and requires a license from the National Drug Administration)

▲Respirators for Class II medical devices.

  1. Home respiratory support equipment (non-life support). Includes: home respiratory support equipment, home non-invasive ventilators, non-invasive ventilators, continuous positive pressure ventilators, continuous positive pressure ventilation machines.
  2. Sleep apnea treatment equipment. Includes: sleep ventilators, sleep noninvasive ventilators, continuous positive pressure ventilators, dual level noninvasive ventilators, positive pressure ventilation therapy machines.
  3. Respiratory masks, medical airway wetting apparatus, esophageal tracheal intubation used with ventilators.

▲The respirators that fall into the three categories of medical devices are.

  1. Therapeutic ventilators (life support). Including therapeutic ventilators, respirators.
  2. First aid and transfer to a ventilator. Includes emergency ventilators, out-of-hospital transfer ventilators, emergency and transfer ventilators.
  3. High frequency ventilators. Includes high frequency jet ventilators, high frequency oscillatory ventilators.
  4. Home ventilators (life support). This includes ventilators, home ventilators.

Qualifications required for export

Medical Device Business License

The corresponding foreign certification (“laissez-passer”) is also required.

Europe: CE

Australia: TGA

Canada: CMDCAS

Korea: KFDA

Japan: PMDA

United States: FDA