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Medical Device Registration Check FAQ Summary--Design And Development
Oct 09, 2017

1, the part of the declaration of specifications model products without sample production and inspection records;

2, failure to provide registration of all specifications of the model product electromagnetic compatibility report;

3, the provision of false sample production records (note: The provision of false records can be terminated on-site inspection);

4, not to provide product packaging, packaging drawings, and label design drawings;

5, check the design documents, part of the examination and approval of the specifications in the drawings and technical requirements of the parameters of the scope of the inconsistent;

6, the three products reported different time, but the same set of technical documents used, documents can not be differentiated;

7, check technical data, some product drawings are not complete;

8, design and development output document is not clearly identified and traceability requirements;

9, not in accordance with the requirements of the registration certificate for the use of this product after the long-term follow-up after the operation, did not form a phased quality tracking report, and product safety information evaluation;

10, the product has the index modification, failed to provide the revision to the product safety validity influence Appraisal process record;

11, design changes did not make the corresponding design changes review, verification and validation;

12, the Enterprise System Assessment product specification model than the last registration has changed, but the enterprise did not change part of the changes to retain the design change review record;

13. Risk management reports do not assess the risk of each hazard, nor do they have a clear assessment of the conclusions;

14, Risk management report does not reflect the design and development phase of risk control measures;

15, in the product development process not to the research and development of raw materials procurement control and supplier review;

16, accept the entrusted production Enterprises, the subsidiary company has not retained the technical documents.