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Which Market Access Method is More Suitable for the Production of Disposable Surgical Masks?

Companies want to produce disposable surgical masks, but they are worried about the cost of investment, so they hope to gain market access as soon as possible. Based on the various approaches currently on the market, the overall approach can be divided into the following four approaches. Enterprises can decide which path to choose based on their current situation and target customers, and must not act blindly:

  1. Civil masks

According to GB/T 32610-2016 Technical Specification of Daily Protective Mask, civil masks are produced, but at the same time, the masks are also tested in accordance with the standards of surgical masks, and inspection reports from authoritative third-party inspection agencies are obtained. In this way, the product packaging cannot be claimed as a surgical mask, and there is no need to apply for a medical device registration certificate, which can save time. However, the company also inspects the mask production line in accordance with the standards for surgical masks, which can guarantee the quality of the masks and can also be used for general protection of non-medical personnel.

  1. Export to domestic sales

All local drug regulatory bureaus have issued green channels for the transfer of exported medical devices to domestic sales. For companies that originally produced foreign standard masks for export and have the ability to produce domestic standard masks but have not obtained relevant qualifications, they can quickly obtain market approval through these green notices. It can be sold to medical institutions for urgent use.

  1. Production of emergency medical equipment products for the record

Many non-medical device companies or companies that did not produce export masks also want to establish mask production lines. The difficulty will be a little bit more difficult, but some drug administrations have procedures for the production of emergency medical device products, which can help these companies quickly obtain product records. For example, Jiangsu Province has such a policy. However, it is not easy for these companies to build a new production line and establish a basic quality management system to pass the on-site inspection by the Food and Drug Administration. It is necessary to have the guidance of personnel familiar with the medical device industry, and to communicate closely with the drug supervision personnel to make timely corrections.

Although this route and the “export-to-domestic sales” route are not difficult and the time is relatively short, the validity period of the obtained filing certificate will not be too long, and it can basically only be used during the epidemic.

  1. Obtain the class Ⅱ medical device registration certificate

This is the most formal path, and it is also the most difficult and most invested path on the mask production line.

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