The Government of Indonesia has enacted the Government Regulation (“GR”) No. 28 of 2024 on The Implementing Regulation to Law No. 17 of 2023 on Health on 26 July 2024 and came into effect the day it was enacted (“GR 28/2024”). In this legal alert, the key provisions of GR 28/2024, specifically on medical device distribution will be examined, including the general provisions of medical device distribution, good distribution practices, withdrawal from distribution, destruction, and sanctions.
The general overview of the GR are as follows:
1. General Provisions on Medical Device Distribution
The distribution of medical devices is distributed into two activities: distribution and delivery (penyerahan). These activities can only be conducted by pharmaceutical management facilities (fasilitas pengelolaan kefarmasian), producers (produsen), and distributors of medical device (distributor alat kesehatan). The distribution of medical devices must be carried out in accordance with good distribution practices (elaborated further in point 2 below).
The distribution of medical devices can only be distributed after the said subjects above has obtained the business licenses (i.e., distribution permit (izin edar)), in which the distribution itself may be conducted by utilizing an electronic system integrated with the National Health Information System (Sistem informasi Kesehatan Nasional).
2. Good Distribution Practices
Good Distribution Practices (Cara Distribusi Alat Kesehatan yang Baik (“CDAKB”)) is regulated in the Minister of Health (“MoH”) Regulation No. 4 of 2014 on the Good Distribution Practices for Medical Devices (“MoH 4/2014”).
CDAKB is defined as guidelines used in a series of distribution and quality control activities that aim to ensure that distributed medical device products always fulfil the specified requirements according to their intended use. In relation thereto, CDAKB consists of various aspects such as complaint handling, Field Safety Corrective Action (FSCA), internal audit, and management studies.
Following the above, MoH through the Circular Letter of the Director General of Pharmaceuticals and Medical Devices Number FR.03.01/E/884/2024 on the implementation of CDAKB Certificate as a Condition for Distribution Permit enforces the obligation for CDAKB certification as a prerequisite for obtaining a distribution permit for medical devices from medical device distribution. The implementation of the CDAKB is socialized from May 1st to June 30th 2024 and has taken effect on July 1st, 2024. Hence, as of July 1st, 2024 a CDAKB Certification is obligatory for medical device distributor for the application of a distribution permit.
3. Withdrawal From Distribution
The imposition of withdrawal from distribution will apply if the distribution permit holder and/or business actor involved in the production or distribution of medical devices fails to comply with the standards and/or requirements for safety, efficacy/benefits, and quality, as well as labeling. Consequently, the distribution permit holders and/or business actors must withdraw the medical devices from circulation. Provisions regarding the withdrawal of medical devices will be regulated by the minister’s regulation and the regulation of the heads of non-ministerial government institutions that carry out government affairs in the field of drug and food control (in accordance with their authority).
4. Destruction
Destruction shall be carried out on medical devices that:
a. Fail to meet standards and/or requirements;
b. Do not have a distribution permit;
c. Have its distribution permit revoked;
d. Have its distribution permit expires and no extension is made;
e. Are expired; and/or
f. Are related to crimes in the health sector.
The above destruction shall be carried out by taking into account the impact on human health as well as efforts to preserve the environment. Further provisions regarding the destruction of medical devices shall be regulated in the minister regulation and regulations of heads of non-ministerial government institutions that carry out government affairs in the field of drug and food control (in accordance with their authority).
5. Sanctions
Administrative sanctions will be imposed to every distribution permit holder and/or business actor in the field of medical devices, who fulfill the following criteria:
a. Fails to carry out efforts to ensure product quality and safety from manufacturing activities to distribution as referred to in Article 407.1;
b. Fails to carry out Pharmacovigilance and Vigilance as referred to in Article 408.2 and 3;
c. Fails to withdraw from circulation products that do not comply with standards and/or requirements, safety, efficacy/benefits, and quality, as well as labelling as referred to in Article 411.1;
d. Fails to destroy products that do not meet standards and/or requirements, does not have a distribution permit, has its distribution permit revoked, has its distribution permit expires and is not extended, and expires as referred to in Article 412.2;
e. Fails to meet the provisions for good manufacturing practices as referred to in Article 413.3;
f. Distribute pharmaceutical preparations and medical devices not in accordance with good distribution practices as referred to in Article 416.3;
g. Have products with labeling that do not comply with the provisions as referred to in Article 423.1; or
h. Carries out promotions and/or advertisements that do not comply with the provisions as referred to in Article 424.1.
In relation to the above, the administrative sanctions shall be imposed in the form of:
a. Reprimand;
b. Temporary suspension of business activities through suspension of business licenses;
c. Imposition of administrative fines;
d. Imposition of police force; and/or
e. Revocation of business license.
Further, the imposition of police forces as referred above shall consist of:
a. Withdrawal from circulation;
b. Compensation;
c. Destruction;
d. Closing or blocking electronic systems and/or other internet media; and/or
e. Closing access to business licensing applications.
Notably, the above administrative sanctions shall be imposed either cumulatively or in stages, depending on the level of risk of violation, in accordance with provisions of laws and regulations. In relation to this, the Directorate General, Chief of Health Services in Provincial area, and Chief of Health Services at the Regency/District level will supervise the distribution of medical device, in which the supervision may include CDAKB audit, examination of facilities and infrastructure; sampling and testing, and monitoring of labelling and advertising.
If you have further questions regarding this matter, please do reach out to us.
