First registration period for Class II medical devices
Project approval stage
Plan, budget, 1 month.
Document preparation before acceptance
Considering that the average cost of testing is 6 months, it may vary depending on the product situation.
Clinical trials cannot be performed in parallel with testing, and the clinical time should be calculated separately, and the budget should be at least 12 months.
Preparation of registration data can be performed in parallel with testing or clinical practice.
After acceptance
NMPA statutory consumption budget for 8 months. (158 working days, 20 working days/month, excluding holidays)
The time limit for issuing supplements is 0 to 12 months, and the average time is considered to be 6 months. It depends on the situation of the first declaration of the product.
System assessment: apply for system assessment within 10 working days after acceptance. Complete the system assessment within 1 month. If the assessment and rectification fail, the review will be withdrawn.
System rectification: According to the degree of system assessment and rectification, it is divided into
(a) 1-month rectification period, after the completion of a review stage.
(b) After a 6-month rectification period, it will enter the second review stage.
The time for system assessment and system rectification is parallel to the technical review stage.
Total budget
For the first registration of domestic Class II medical devices without clinical trials, the budget should be at least 15 to 21 months.
For the first registration of clinical domestic Class II medical devices, the budget should be at least 33 months. (Among them, 12 months are clinically considered.)
First registration period for Class III medical devices
Project approval stage
Plan, budget, 1 month.
Document preparation before acceptance
Considering that the average cost of testing is 6 months, it may vary depending on the product situation.
Clinical trials cannot be performed in parallel with testing, and the clinical time should be calculated separately, and the budget should be at least 12 months. Preparation of registration data can be performed in parallel with testing or clinical practice.
After acceptance
NMPA statutory consumption budget for 10 months. (188 working days, 20 working days/month, excluding holidays)
The time limit for issuing supplements is 0 to 12 months, and the average time is considered to be 6 months. It depends on the situation of the first declaration of the product.
System assessment: apply for system assessment within 10 working days after acceptance. Complete the system assessment within 1 month. If the assessment and rectification fail, the review will be withdrawn.
System rectification: According to the degree of system assessment and rectification, it is divided into
(a) 1-month rectification period, after the completion of a review stage.
(b) After a 6-month rectification period, it will enter the second review stage. The time for system assessment and system rectification is parallel to the technical review stage.
Total budget
For the first registration of domestic Class III medical devices without clinical trials, the budget should be at least 17 to 23 months.
For the first registration of clinical domestic Class III medical devices, the budget should be at least 35 months. (Among them, 12 months are clinically considered.)