On March 31st, 2020, China issued the “Notice Regarding Orderly Development of Medical Goods Exports applicable to the exports of Private Protective Equipment (“PPE”)”, effective April 1, 2020 (the “Notice”).
The Notice is intended to insure the quality of PPE by requiring that Chinese manufacturers of PPE have proper certifications by the State Food and Drug Administration (“SFDA”) and that the manufacturers be listed in the national medical products registry maintained by the SFDA.
The PPE categories covered include the following types of products for fighting coronavirus which require verification:
- Coronavirus Testing Kits
- Medical Protective Outfits/Gowns
- Medical Protective Masks
- Surgical Masks
- Disposable Medical Masks
- Ventilators and
- Infrared Thermometers
The verification involves not only testing the specific products but also verifying the manufacturers’ hardware, personnel qualification and process by the SFDA.
All such PPE exports will be checked at export customs control points to insure that proper paperwork is presented. The purpose of this Notice is to protect consumers and recipients of exported Chinese PPE from sub-standard or defective products. This memo summarizes the requirements to insure that foreign buyers select proper suppliers prior to placing purchase orders. This memo focuses on testing kits only as an example. The requirements for other PPE categories should be specifically checked against the specific regulations.
What Was Required Before the Notice?
In addition to the normal export documentation requirements (invoice, packing list and export contract), coronavirus testing kits are special goods under “Regulations for Administration of Entry and Exit Health Quarantine on Special Goods” issued by the SFDA in 2005 (the “Regulation on Special Goods”), and therefore require an Export Health and Quarantine Permit (“EHQP”) issued by the SFDA for export.
The exporter must provide the following documents before shipping to the customs office, which then coordinates with the SFDA officials to verify the contents:
- Application Form for Examination and Approval of Entry and Exit Health Quarantine on Special Goods (”Application Form for Approval”)
- Descriptions of the special items, including English names, categories, ingredients, sources, uses, major sales channels, countries or regions where they are exported, manufacturers, etc.
- If the special items contain or may contain pathogenic microorganisms, the name of the pathogenic microorganism (Chinese and Latin), the explanatory documents of biological characteristics (Chinese and English) and the supporting documents of the corresponding level of biosecurity prevention and control of the production operator or user shall be provided.
- Biological products or human blood products for the prevention, diagnosis and treatment of human diseases abroad shall provide a free sales certificate issued by the drug supervision and administration department
- If the special goods of export involve the management of human genetic resources, the approval documents issued by the management department of human genetic resources shall be provided.
- Special goods that contains or may contain pathogenic microorganisms, exporters shall provide a biosecurity laboratory qualification appropriate to the biosecurity risk level, and laboratories above BSL-3 levels must be approved by a national authorized institution
- If the special goods contains highly pathogenic microbial bacteria (toxic), species (toxic) or samples, exporters shall provide the approval documents of the competent department of health of the government at or above the provincial level
The SFDA will render a decision on the EHQP to the manufacturer within 20 working days.
Which New Requirements Were Introduced by the Notice?
In addition to the EHQP described above, the Notice requires all the exporters of PPE to also obtain a Medical Device Registration License issued by the SFDA (“MD License”). The MD License is issued based on the assessment of the manufacturer’s quality control systems and the specific product’s testing performance. It usually takes anywhere from six months to two years for the SFDA to complete the assessment and issue the MD license. Without a satisfactory assessment by the SFDA on their quality control systems, manufacturers will not be able to obtain an MD License, even if the specific products satisfy the national standard.
According to “Regulations on the Supervision and Administration of Medical Devices” issued by the State Council in 2014 (the “Regulation on MD”), manufacturers of medical devices are classified into three categories:
- Category I is low risk level, where the implementation of conventional management can ensure the safety and effectiveness of the medical devices;
- Category II is for medical devices with moderate risk, the manufacturing of which needs to be strictly controlled to ensure their safety and effectiveness; and
- Category III is for medical devices with high risk, where special measures are required to strictly control manufacturing to ensure their safety and effectiveness.
According to the medical devices categories catalog published by SFDA, different types of PPE are categorized as in the table below:
|Category I||Category II||Category III|
|1. Coronavirus Testing Kits||x|
|2. Medical Protective Outfits||x|
|4. Medical Protective Masks||x|
|5. Surgical Masks||x|
|6. Disposable Medical Masks||x|
|7. Infrared Thermometers||x|
How Long Does it Take to Obtain the MD License ?
Testing kits are Category III products according to the SFDA statement issued on 30 March 2020. Overall it takes between 6 months and two years for a non-certified Category III product manufacturer to receive their MD License.
Is There an Emergency Approval Procedure?
Yes, there is an emergency approval procedure for obtaining an MD License. According to article 2 of the “Emergency Approval Procedures for Medical Devices” issued by the SFDA in 2009 (the “EAP”), “[…] when there is a threat of a public health emergency, or the occurrence of a public health emergency, the Food and Drug Administration shall, in accordance with the principles of unified command, early intervention, rapid, efficient and scientific approval, implement emergency approval for medical devices required for emergency treatment of public health emergencies.” There is no specified timeline provided by EAP. This needs to be handled on a case by case basis.
Are There Exemptions Available for Certain Suppliers?
No, regardless of whether the manufacturer or their products have gained import approval in a foreign country. The US FDA/CE certificates for each product are a requirement for export, however they are not replacements for Chinese certificates/approvals required by law. Given recent media reports of defective or substandard product being exported, the Chinese authorities are not granting any exemptions.
Is There an Official List of Verified PPE Suppliers?
Yes, it is published on the SFDA’s website and updated from time to time. In the full list, there are 23 testing kits suppliers, 32 ventilators suppliers, 301 medical gown suppliers, 1,425 masks suppliers and 236 infrared thermometers suppliers. The list does not provide the contact information of the suppliers. We have translated the testing kits suppliers’ information only into English for illustration purposes. If you need the translation of the other suppliers or need to search contact information, or services for due diligence report, please contact Jian Zhang at email@example.com.