Costs( see details ) |
Timeframe ( see details ) |
||
USD
12,580
|
|
Registration of imported medical devices | |
USD
500
For medical device Class A non-exempted from registration
|
|
USD
2,500
For medical devices class B, C and D
|
|
USD
150
Variation-minor
|
|
USD
300
Variation-major
|
|
USD
200
Retention- Class A
|
|
USD
200
Class B, C and C
|
|
USD
100
Duplicate certificate
|
|
Registration of imported in vitro diagnostic devices | |
USD
350
Class A
|
|
USD
1,250
Class B
|
|
USD
1,500
Class C
|
|
USD
2,000
Class D
|
|
USD
125
Variation-minor
|
|
USD
250
Variation-major
|
|
USD
250
Retention
|
|
USD
100
Duplicate certificate
|
|
Other costs | |
Registration of domestic medical devices | |
USD
75
class B
|
|
USD
250
Class C,D
|
|
USD
75
Class B
|
|
USD
250
Class B and D
|
|
USD
50
Variation- minor
|
|
USD
75
Variation-major
|
|
USD
100
Retention
|
|
USD
25
Export certificate
|
|
USD
30
Duplicate certificate
|
|
Registration of domestic in vitro diagnostic devices | |
USD
125
Class A
|
|
USD
250
Class B
|
|
USD
375
Class C
|
|
USD
400
Class D
|
|
USD
125
Variation-minor
|
|
USD
250
Variation-major
|
|
USD
250
Retetion
|
|
USD
100
Duplicate certificate
|