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Type II transformation plan
Three types of transformation plan
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Transformation plan
Type II transformation plan
Three types of transformation plan
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Solutions for traditional enterprises transforming into instrument manufacturers (Class II)
Self-built factory
Large investment, long time, high labor cost, high maintenance, and difficult compliance
Enterprise hardware investment
Admission funds
10 million 500 thousand
Basic cycle of product launch
3 years
Commissioned production
Less investment, shorter time, faster listing, faster returns, and compliance assurance
Enterprise hardware investment
capital
1 million 500 thousand
time
1.5 years
Threshold for manufacturing medical device enterprises
(Category II)
Admission funds
10 million 500 thousand
Basic cycle of product launch
3 years
Note: The above fees do not include clinical and registration fees
The transformation threshold costs mainly include:
Venue rent
Workshop decoration
Water and electricity maintenance
Personnel expenses
The threshold of medical devices under the registrant system
(Class II)
Admission funds
1 million 500 thousand
Basic cycle of product launch
1.5 years
86%
Decrease of funds
50%
Time reduction
Note: The above fees do not include clinical and registration fees
The transformation threshold costs are mainly saved:
No need to build plant
No need to recruit personnel
Quick evidence collection
Customizable products
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