As there seems to be a resurgence or second wave upon the horizon in Ireland some enterprises or entrepreneurs may consider importing personal protective equipment (PPE) from China. Although the market for PPE has stabilised there still remains some issues and considerations which must be considered when purchasing PPE from China. In this post, I have put together some tips which I hope will help ensure a safe and legally procurement of personal protective equipment from China.
European market standards
Personal protective equipment includes a wide array of medical gear.
· Medical Protective Clothing (e.g., surgical gowns, isolation gowns, and coveralls)
· Surgical Masks
· Disposable Face Masks
Each of the above products fall under different classes which come with different regulatory requirements. It is essential that the importer checks and confirms the CE requirements. As the importer, the liabilities within Europe will fall upon you.
Finding Qualified PPE Manufacturers
Due to new regulations issued by the Chinese customs authorities related to personal protective equipment, you must make sure that the manufacturing company you are considering buying from is permitted by the Chinese Government to export PPE.
You must ensure that the exporting party has all the necessary permits and licenses in China as well as prior examination by a European Notified Body. These permits and licenses shall include:
· Medical Device Manufacturing Enterprise License (MD License) issued by the State Food and Drug Administration (SFDA)
· Medical Device Products Registration Certificate from the SFDA for every product to be sourced
· Food and Drug Administration (FDA) Verification of the Exportation Destination Country
· Export License
· Export Health and Quarantine Permit (EHQP) issued by the SFDA
. Plant & Product examination and certification by a Notified body from Europe
The reality of the personal protective equipment manufacturing industry in China is that very few small manufacturing companies are actually capable or qualified to handle bulk purchases. Orders are often delegated to subcontractors and it is the purchasers obligation to ensure that the subcontractor who will be working on your orders is legally authorized to manufacture and export PPEs.
Conduct Your Own Factory Audit
An unfortunately common issue is that some unscrupulous PPE suppliers are using questionable methods to acquire their export permits or even using “borrowed” permits to export medical equipment manufactured in sub-standard facilities. The Chinese authorities are doing their best to eliminate such practices, however a few manufacturers are bound to slip through the cracks. Therefore to mitigate risk, it is advisable to contract a private company to carry out a factory audit to ensure that the facilities and plants where the protective equipment is manufactured comply with the quality standards and have previously been audited by a EU notified body. It is crucial to always confirm the veracity of any reports which the manufacturer shows you.
Sample Inspection Before Shipment
While licenses and permits will indicate whether the manufacturer can produce high-quality personal protection equipment, you are still responsible for making sure that your particular order complies with quality standards and as the importer you will bear all liability in Europe should the products fail to have the correct certification. It is vital to employ a professional third-party independent quality assurance/control company in China to inspect the protective gear against the required standard during production, upon completion of the order and before delivery.
Contrary to what may be believed, it is highly recommend that you choose a local court, where the supplier is located as the court which will have jurisdiction over the case. An important facet of dispute resolution is to always choose the jurisdiction where the other party has assets, this ensures ease of recovery following a favourable judgement. While an Irish court maybe cheaper and easier to take a case in, enforcing a judgement from Ireland on a defendant in China will be next to impossible.