The new regulatory updates from Indonesia (2020-2021) include:
1. SIKLARA
SIKLARA is an online interactive tool to help prospective medical device registrants define the classification of medical devices and IVDs. This tool was established based on ASEAN Medical Device Directive (1).
2. Simplified registration pathway for certain low-risk medical devices (notification)
Some low-risk medical devices (class A) with the following criteria will be eligible for this procedure: home use, non IVD, non sterile device. The following 34 device categories that are eligible for this pathway are shown on this list.
The implementation of this pathway, however, has not been announced by the Ministry of Health.
3. Instruction for Use (IFU) in local language
The IFU must now be translated into Bahasa Indonesia regardless of whether the product is intended for healthcare professionals or layman. However, the label/packaging may remain in English.
4. Halal certification for medical devices containing Animal Derived Materials (ADMs)
Halal certification for medical devices containing Animal Derived Materials (ADMs) is mandatory and will be done in phases starting on October 17, 2021 (2).
- Class A: October 17, 2026
- Class B: October 17, 2029
- Class C: October 17, 2034
- Class D: Not determined yet.
Local halal certification for imported product must be created by the importer or local authorized representative. The scope of certification includes document evaluation and facility inspection.
If a product has been given halal-certification by a country that has a mutual recognition agreement with the Indonesia Halal Certification Body, it will be exempted from this certification. In this case, the halal certification process will be simplified and will include the document evaluation only.
References
- Association of Southeast Asian Nations (ASEAN). List of Instruments. ASEAN Legal Instruments. [Online] November 21, 2014. http://agreement.asean.org/media/download/20141204115621.pdf.
- Ministry of Religious Affairs. Peraturan Menteri Agama (PMA). Kantor Wilayah Kementerian Agama DKI . [Online] October 15, 2019. https://dki.kemenag.go.id/media/laws/6-191126090909-5ddc89454ec65.pdf.
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