Technical guidance are aimed at helping its technical reviewers and the industry to understand the key criteria for evaluating the safety and effectiveness of relevant products. Though conformance to these are not mandated by law, such technical guidance are extremely helpful in providing insight into:
- Product classification and division of registration unit in China
- Relevant Chinese product standards
- Pertinent risks and past adverse events particular for the kind of devices
- Product testing requirements and recommended testing methods
- Clinical trial and clinical data requirements
- Key area of focus during technical review
This recent announcement adds the following products to a pool totaling about 90 Chinese technical guidance (include both medical devices and IVD reagents):
- Temperature-controlled blanket for medical use
- Electronic gastric suction equipment
- Electronic medical thermometer
- Pulse oximeter
- Electrical Handpiece for dental use
- C-reactive protein (CRP) detection kit
- Ischemia modified albumin (IMA) quantitative determination kit
- Creatine kinase quantitative determination kit
- Alkaline phosphatase detection kit
- Medical masks
- Single-use drainage tube
- Umbilical cord protection band
- Single-use laryngeal mask
- Single-use skin stapler
The 120 newly published non-mandatory product standards boost the pool of medical device standards to over 600. Although most of these guidance are either adopted or equivalent to the European harmonised standards, particular attention must be paid to the version adopted, interpretations of requirements and other local variations. Any non-conformance to a relevant Chinese product standard could deter you from receiving regulatory approval.
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