Imported Products Must Provide COVID-19 Nucleic Acid Test Report

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On January 25, 2021 the China National Health Commission issued the Technical Guideline for COVID-19 Prevention and Control on Manufacturers and Suppliers of Imported Products.

Mentioned in the guidelines, “the production and business operation entities shall take the initiative to obtain and inspect safety and epidemic prevention testing information, such as the supplier’s license, quarantine certificate of imported products, COVID-19 nucleic acid test report and preventive disinfection certificate, from suppliers. Those with incomplete, unmatched or unqualified certificates are not allowed to be stored, processed or sold.”

Guideline Interpretation

The guidelines put forward specific measures to further strengthen the epidemic prevention and control work on imported product manufacturing and operation enterprises from the aspects of material, personnel and environment.

Process Control on Imported Products during COVID-19

China is tightening the whole process control on the source, loading and unloading process, production, processing and storage process, sales management of imported products to make them traceable. Nucleic acid testing and disinfection on both outer and interior packings are to be conducted. Once the positive sample of the nucleic acid test is found, emergency disposal action should be strictly taken according to the requirements.

Facilities and Environmental Disinfection

The transport vehicles of imported products, storage facilities, production and processing sites, sales and operation sites and other links shall, as required, take protective measures such as cleaning and disinfection, ventilation. Cleaning and disinfection supplies, hand washing and disinfection facilities and warning boards should be  allocated to keep the workplace clean and orderly.

About China Med Device

China Med Device, LLC, provides regulatory and commercialization turnkey solutions for medical device, IVD, CDx and combination products in China. As a qualified NMPA (CFDA) legal agent with offices in Boston and Beijing, we can represent manufacturers for the complete product life cycle without their need to create a local entity in China.

Our NMPA (CFDA) regulatory services include strategy, registration, local type testing, product technical requirement (PTR), clinical evaluation report (CER), clinical trial, GMP and post-market surveillance (AE, recall, inspection, etc.). Our commercialization services include market research, reimbursement, partnership strategy and distribution qualification.