3.2 regulation of medical devices - who

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Page 1: 3.2 Regulation of medical devices - WHO

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3.2 Regulation of medical devices� � � � � � � � � � � � � �� � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � ! � � � � ! � � � " � � � � � � ! � � � � � � # � � � � � � � � # � � � � � � � � � �� � � � � � � � ! � � ! $ � � � � � % & � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � ' ! � � � � � � � � � � � � � � � � � � � � � � � ! � � � � � � � � � � � ! � � � � � � � � � � �� � � � � � � � � � � � � ( ) ! � � � � � � � � � � � % � � � � � � � � � � & � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � # � � � � � � # � � � � � � # � � � ! � � � � !� � � � � � � � () * + ! � � � � � � � � � � & � � � � � � � � � � � � � ! � ) � � � � * � � � � ! , � � � � # � % - ) * , . � � � � � � � � � � / 0 ( 1 2 � � * � � � � ! � � � ! � � � � � � � �' ! � � ! � � � � � � � � � � 3 4 � � # � � 5 � � � � � � � � � � ' � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � %� � � � � � � � � � & ' ! � � � � � � � � � � � & � � � � � � � � � � � � � � � � � � � � � � � � � � ! � � � � � � 6 � � � � � 7 8 (9 ! � / : � ! ) * , � � 1 0 ; < � � � � � � � � � � � � � � � � / : ( 1 0 � � � � � � � � � � � % � % � � � � � � � � � � � ! � � � � � � � � � � � � � � � � � � � � � � = > ( ? �� � � � � � � � � ! � � � � � � � � � � � � � ! � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � ! � � � � � � � � � � � � � � � & � � � # � � � � � � # � � �! � � � � ! � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � & � � � � � � � � � � � � $ � � � � � % � � � � � � � � � � � � � � ( 9 ! � � � � � � � � � � @ � � � � ! �� � � � � � � � � � � � � � � � � � � � � � � � � � � � ) * , / : ( 1 0 (

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WPROSEAROEUROEMROAMROAFRO

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13

3

3

5

6

16

11

2315

48

6 13

18

2

6

1

2

3

N=194

Percentage of countries with a legal framework

14

0 20 40 60 80 100

Adverse event reporting

Import controls

Registration of establishments

Listing of medical devices

Essential principles

Risk classes

Definition

69

78

86

93

73

69

65

N=113

Page 5: 3.2 Regulation of medical devices - WHO

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7

28

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14

27

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Page 6: 3.2 Regulation of medical devices - WHO

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Page 7: 3.2 Regulation of medical devices - WHO

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A � � ( B ( 1 C ; < � O � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � ) � � � � � � � " � � � � � � � � � �

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16

16

23

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Page 8: 3.2 Regulation of medical devices - WHO

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Page 9: 3.2 Regulation of medical devices - WHO

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Page 10: 3.2 Regulation of medical devices - WHO

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