On April 1, 2021, the Indonesia Ministry of Health issued Regulation of the Minister of Health Number 14 of 2021 concerning Standards for Business Activities and Products in the Implementation of Risk-Based Business Licensing in the Health Sector. Issuance of these regulations corresponded with the issuance of Job Creation Law (Law of Republic of Indonesia No 11 of 2020), in providing ease of doing business in Indonesia by accelerating and simplifying the licensing process. Therefore, MoH simplified the product marketing authorization licensing process, one of which is class A medical devices which are considered as low-risk medical devices.

The criteria for certain Class A Medical Devices are Home Use, Non-Sterile, and non-IVD. For more details, the following is a list of the 34 certain Class A medical devices that can be processed through a simplified route:

No.

Product Name

No.

Product Name

1

Arm sling

18

Mechanical Walker

2

Body waste receptacle

19

Medical adhesive tape and an adhesive bandage.

3

Cane

20

Medical disposable bedding

4

Cane, crutch, and walker tips and pads.

21

Medical insole

5

Cold pack.

22

Moist heat pack.

6

Crutch

23

Nipple shield

7

Dental floss

24

Nonresorbable gauze/sponge for external use

8

Elastic bandage

25

Ophthalmic eye shield

9

Flotation cushion

26

OTC Denture cleanser

10

Hernia support

27

Patient scale

11

Hot or cold disposable pack.

28

Protective garment for incontinence.

12

Hot/cold water bottle

29

Scented or scented deodorized menstrual pad

13

Ice bag

30

Stand-on patient scale

14

Limb orthosis  

31

Teething ring

15

Manual breast pump

32

Therapeutic massager

16

Manual toothbrush

33

Truncal orthosis

17

Mechanical wheelchair

34

Unscented menstrual pad

The documents requirements need to be submitted for the simplified route are as follow:

  1. Administrative document: Legalized Letter Of Authorization, Free Sale Certificate from Country of Origin or GHTF Countries
  2. Technical documents: Quality Management System Certificate (ISO 13485), Declaration of Conformity from the manufacturer, Raw material information, Technical Spec of Medical Device, Label, User manual (IFU)

However, the duration of the review itself remains the same as the regular registration route, which will require a maximum of 35 working days for Class A medical devices.

The Ministry of Health stated that there is a possibility that the duration of the review will be shortened as a trial of simplifying route is conducted. Although this new route has been socialized, the implementation of a simplified route hasn’t been determined yet. Currently, MoH is still doing improvements of the online registration system to be adjusted with this new registration route.

 

 

References:

PMK Socialization Material No. 14/2021 concerning Standards for Business Activities and Products in the Implementation of Risk-Based Business Licensing in the Health Sector

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