AMENDMENT OF MALAYSIAN STANDARD REGULATORY REQUIREMENT ON GOOD

DISTRIBUTION PRACTICE OF MEDICAL DEVICE MDR/RR No 1: JULY 2013

(i)

amendment to table (5) in Annex 1.

To change content of Table 5 as follows:

No

GMDN
Category and
Description

Manufacturer

Brand/ model

Grouping (single/
family/ system/ test
kit/cluster)

Class
(A/B/C/D)

1
2
3

Current Table (5) in Annex 1:

No Name of medical Manufacturer
device

Brand/ Manufacturer Grouping (single/

model
product
family/ system/
number/code test kit/cluster

Class

GMDN Medical device

code
registration
number*

1
2
3

New Table (5) in Annex 1:

No

1
2
3

GMDN
Category and
Description

Manufacturer

Brand/ model

Grouping (single/
family/ system/ test
kit/cluster)

Class
(A/B/C/D)