There have been 92 recalls from overseas manufacturers reported to the NMPA in 2022, as of December 21. Many big names are on the list. Abbott, bioMerieux, Biomet, BD, Medtronic, and Smith & Nephew are among the most recalls.
Recalls Overseas Manufacturers 2022 Regulation
“Administrative Measures for the Recall of Medical Devices” released in February 2017 stipulates that “medical device manufacturers conduct recall defective products by warning, inspection, repair, re-labeling, modification, and improvement of IFU, software update, replacement, recovery, destruction, etc. Foreign manufacturer can designate an agent in China to conduct the recall.
The “defective” medical device products have the following scenarios:
- Products with unreasonable risks that may endanger human health/life under normal use
- Products that do not meet the technical requirements or mandatory standards
- Products that do not meet the relevant production and qualify management regulations which may lead to unreasonable risks
- Other products that need to be recalled
About China Med Device
China Med Device provides regulatory and commercialization turnkey solutions for medical device, IVD, CDx and combination products in China. As a qualified NMPA legal agent with offices in Boston, Beijing and Hainan, we can represent manufacturers for the complete product life cycle without their need to create a local entity in China.
Our regulatory services include strategy, registration, type testing, product technical requirement (PTR), clinical evaluation report (CER), clinical trials, recall information, IVDs draft guidelines, GMP and post-market surveillance. Our commercialization services include market research, reimbursement, partnership strategy and distribution qualification.