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