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Q：
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Our Beijing company would like to sell medical protective masks and protective suits, do we need to apply for any extra permit or license?
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A：
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Yes, medical protective masks and protective suits belong to class II medical devices, so your Beijing company must apply for registration voucher for selling Class II medical devices with local Food and Drug Supervision Bureau. Before that, you must apply for change of business scope by adding the business activity of seeling Class II medical devices with the Beijing Administration for Market Regulation.
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Q：
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What requirements do the enterprise have to meet to apply for registration voucher for selling Class II medical devices?
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A：
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With quality supervision institution and personnel suitable for the business scope and operation scale. The personnel should have obtained professional qualifications and title.
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With an operation and storage place suitable for the business scope and operation scale
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Meet the goods storage conditions, if other medical devices companies are entrusted to store the goods, warehouse may not be set up.
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With a quality supervision system suitable for operation of the medical devices, including procurement, purchased goods approval, warehouse storage, warehouse management, warehouse review, quality tracking and adverse event reporting.
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With the ability of professional guidance, technical training and after-sales service that are compatible with the operation of medical devices, or technical support is provided by relevant institutions as agreed
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Q：
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What kind of materials are required for the registration voucher for selling Class II medical devices?
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A：
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The required documents mainly include:
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Business license
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Identity certificate, academic qualification or professional title certificate of the legal representative, the person in charge and the person in charge of quality
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Enterprise organization and department setting instructions, operation place, geographic location drawing of the warehouse, floor plan, warehouse property ownership certificate and usage certificate
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Enterprise facilities and equipment, including operating facilities, equipment catalogue, Operation quality management system, working procedures and other documents
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Other application documents required to be submitted (Kaizen could help draft)
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Q：
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Is there any requirement on the qualification of the person in charge of quality?
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A：
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Yes, the person in charge of quality should obtain related professional academic qualification or professional tile.
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Q：
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Is there any requirement on the size of the warehouse?
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A：
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Yes, for company selling medical protective masks and protective suits, the warehouse shall be not less than 20 square meters.
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Q：
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Is office on-site inspection required?
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A：
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No, however, pursuant to the Detailed Regulations for On-site Inspection and Evaluation of the Code for Medical Device Operation Quality Supervision issued by Beijing, the official supervision department may conduct on-site inspection within 3 months after obtaining the Registration Voucher for Operation of Class II Medical Devices.
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Q：
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How long does it take for reviewing and issuance of the Registration Voucher for Operation of Class II Medical Devices?
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A：
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It will take one working day to issue the Registration Voucher for Operation of Class II Medical Devices if all applicant documents are satisfied with the official requirements.
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