REGULATORY COMPLIANCE CORRELATION MATRIX

ISO
13485:2003

FDA
QSR

CANADA
MDR

4.1

820.5, 820.20 (e)

2, 3, 5, 6, 7, 26, 28, 29, 30,

31, 32, 33, 34 ,43, 43.1

4.2.1
4.2.2
4.2.3
4.2.4
5.1
5.2
5.3
5.4.1
5.4.2
5.5.1
5.5.2
5.5.3
5.6.1
5.6.2
5.6.3
6.1
6.2.1
6.2.2
6.3
6.4
7.1

820.20 (d, e),

820.40, 820.181,
860
820.3 (v), 820.5,
820.20 (e), 820.186
820.40, 820.181
820.30(j), 820.180,
820.184, 820.186
820.20 (a, b)
820.181
820.20 (a)
820.20 (a)
820.20 (d, e),
820.30 (h)
820.20 (b(1))
820.20 (b(3))
820.20 (a, b(1))
820.20 (c)
820.186
820.186
820.20 (b(2))
820.20 (b(2)),
820.25 (a)
820.25
820.70 (c, f, g)
820.70 (c, d, e, h),
820.140, 820.150
820.5, 820.20 (d),
820.30 (h), 820.80,
820.170, 820.200

7.2.1

820.30 (b, c),

820.50 (b)

7.2.2
7.2.3
7.3.1

820.50 (b), 820.160

806, 820.160
820.30 (a, b, h, j)

7.3.2

820.30 (c)

7.3.3
7.3.4
7.3.5
7.3.6

820.30 (d)
820.30 (e)
820.30 (f)
820.30 (h, g)
820.30 (i), 820.70
(b)
820.50 (a)
820.40, 820.50 (b)
820.80 (a, b)

7.3.7
7.4.1
7.4.2
7.4.3

6, 7, 9(2), 10, 11, 12, 13, 14,

15, 16, 17, 18, 19, 20, 32

MDD 93/42/EEC
Article 9, Annex II
(1,3.2,6.1), Annex IX
Article 3, Annex I, Annex II
(3.1,3.2(a,b,c,d,e),4, 6.1),
Annex VII (3)

JAPAN
Articles 5, 6
Article 6

32(2)(f)

Annex II (3.2)

Article 7

9(2), 34, 43, 52, 53, 54, 55,

56, 66, 67, 68
32(2)(c)
10, 11, 12, 13, 14, 15, 16,
17, 18, 19, 20, 32(1,2,3,4)
-

Annex II (3.2, 6.1)

Article 8

Annex II (3.2, 6.1)

Articles 6(2,3), 9

Annex II (2, 3.1)

Annex II (3.2)
Annex II (3.2(a))

Article 10
Article 11
Article 12
Article 13

Annex II (3.2)

Article 14

Annex II (3.2(b))
Annex II (3.2(b))
Annex II (3.2(b))
Annex II (3.2(b))
Annex II (3.2)

Article 15
Article 16
Article 17
Article 18
Article 19
Article 20
Article 21

Article 22

14

Annex II (5.2)
Annex I(1)

Article 23
Article 24

Annex I(8)

Article 25

9, 10, 11, 12, 13, 14, 15, 16,

17, 18, 19, 20, 32(4)(e,d)

Annex I(2), Annex II(3.2)

Article 26

Annex I, Annex II(3.2(c))

Article 27

Annex II(3.1)
Annex II(3.2(e))

Article 28
Article 29
Article 30

Annex II(3.2(c))

Article 31

Annex II(3.2(c))
Annex II(3.2(c))
Annex II(3.2(c))
Annex II(3.2(c))

Article 32
Article 33
Article 34
Article 35

1, 34, 43(1)(b)

Annex II(3.2(c),3.4)

Article 36

32 (1)(e)
-

Annex II(3.2(d))
Annex II(3.2(d))
Annex II(3.2(d))

Article 37
Article 38
Article 39

2, 3, 4, 5, 6, 7, 8, 9, 10, 11,
12, 13, 14, 15, 16, 17, 18,
19, 20, 21, 22, 23, 24, 26,
27, 28, 29, 30, 31,
32(1,2,3,4), 34, 41, 43, 52,
53, 54, 55, 56, 57, 58, 59,
60, 61, 62, 63, 64, 66, 67, 68
10, 12, 13, 14, 15, 16, 18, 20
10, 11, 13, 14, 15, 16, 18,
19, 32
11, 12, 20, 32(3)(f), 32(4)(i)

ISO
13485:2003
7.5.1

7.5.2
7.5.3
7.5.4
7.5.5
7.6
8.1
8.2.1
8.2.2
8.2.3
8.2.4
8.3
8.4
8.5.1
8.5.2
8.5.3

FDA
QSR
801, 820.30 (h),
820.70, 820.75,
820.120, 820.130,
820.170, 820.184,
820.200
820.3(o), 820.70,
820.75
820.60, 820.65,
820.80, 820.86,
820.120, 820.160
820.120, 820.130,
820.140, 820.150,
820.160, 820.170
820.70 (c, g (3)),
820.72
820.80, 820.250
820.198, 822
820.22, 820.70 (g
(2))
820.22, 820.70,
820.250
801, 820.70 (a (5)),
820.80, 820.120 (b),
820.184, 820.250
820.90
820.100 (a (1)),
820.250
803, 806, 820.20
(c), 820.198
820.100
820.100

CANADA
MDR

MDD 93/42/EEC

JAPAN

17, 21, 22, 23, 32(1)(e),

32(2)(c), 32(3)(c), 32(3)(f,l),
32(4)(d,e,i,m)

Article 17, Annex I

(1,2,3,4,5,6,7,8,9,10,11,12
,13), Annex II(3.2(d), 3.3),
Annex XII

Articles 40, 41,

42, 43, 44

17

Annex I(5,8), Annex

II(3.2(e))

Articles 45, 46

21, 22, 23, 52, 53, 54, 55, 56

Article 1(f,h), Annex I(13),

Annex II(3.2(d,e))

Articles 47, 48,

49, 50

Article 51

14

Annex I(5,13)

Article 52

Annex II(3.2(e))

Article 53

57 (1)(a)

Annex II(3.2(d,e))
Annex II(3.1)

Article 54
Article 55

Annex II(3.1,3.2)

Article 56

Annex II(3.2(b))

Articles 57, 59

Annex II(3.2(e))

Article 58

Annex II(3.2(b))

Article 60

Article 61

Annex II(3.1,3.2(b))

Article 62

Annex II(3.1)
-

Article 63
Article 64

57, 58, 59, 60, 61, 62, 63,

64, 65
57, 58, 59, 60, 61, 62
57, 58, 59, 60, 61, 62