Indonesian Ministry of Health has recently published a guideline aimed at regulating the circulation of Medical Devices (MDs) and Household Health Supplies (PKRT: Perbekalan Kesehatan Rumah Tangga) through electronic systems such as e-commerce and marketplace. These guidelines, signed on 5 April 2024, provide essential information for business actors, medical device manufacturers, and product license holders/distributors. In this article, we’ll explore the key provisions and implications of these guidelines.

Purpose and Scope

The rapid advancement of technology has transformed the way medical devices and household health supplies are distributed, in which many are marketed through electronic systems (E-Systems). Thus, it is crucial to ensure an efficient and safe circulation of MDs and PKRT in E-Systems. The new guidelines address this aim and provide clarity on the responsibilities and requirements for all stakeholders.

The primary purpose of these guidelines is to serve as a reference for business actors involved in the distribution of medical devices and household health supplies. By adhering to these guidelines, manufacturers and distributors can ensure compliance with safety and quality standards.

Key Provisions

Business Actors' Responsibilities

There are two ways for business actors to distribute their products through an electronic system:

1. Distributing through an E-system owned by the business actor themselves. Specifically for MDs, it is mandatory for the business actor to own a Distribution License for Medical Devices (IDAK: Izin Distribusi Alat Kesehatan), Certificate of Good Medical Device Distribution (CDAKB: Cara Distribusi Alat Kesehatan yang Baik), and/or Good Manufacturing Practice for Medical Devices (CPAKB: Cara Produksi Alat Kesehatan yang Baik).
2. Distributing the product through E-Systems provided by the Electronic System Organizers (PPMSE: Penyelenggara Perdagangan Melalui Sistem Elektronik) by fulfilling the provisions of business licensing and including Indonesian Business Classification (KBLI: Klasifikasi Baku Lapangan Usaha Indonesia) for Retail Trade in Medical Devices, namely Medical Devices Stores, Optics and Pharmacies.

Business actors engaged in the distribution of medical devices and household health supplies have specific responsibilities:

• Quality Assurance: Ensuring product quality, safety, and efficacy is paramount.
• Reporting: Report any adverse events related to their devices.
• Traceability: Implementing systems to track the movement of products through electronic channels.

Medical Device Requirements

1. Eligible Products for Electronic Distribution
   The guidelines cover a wide range of products that may be distributed through E-Systems, including:

• Products that can be used by the public or personal-use medical devices without needing professional help.
• Products that do not have a high-risk potential from misusage and misinterpretation.
• Optical medical devices can be distributed with the following criteria: can be used without professional help, non-invasive, does not require high technology in its use and interpretation, does not require health professionals in the interpretation of the results.
• Products such as condoms, band-aids, sanitary napkins, pregnancy tests, sterile equipment, non-invasive In Vitro Diagnostic products, and products for intimate purposes can be circulated through an electronic system considering product safety in accordance with the special provisions of each product.
• Other medical devices as specified by the MoH (refer to the annex, page 24 of the guideline).
  
  
  2. Quality and Safety Standards
• Compliance with Regulations:
  Products must comply with the regulations, having a valid Marketing Approval Certificate.
• Advertisement Content:
  Information stated about the product in the E-system must meet the MD and PKRT Advertising Guidelines as shown in Permenkes No. 14/2021

Supervision and Sanctions

• Supervision:
  Monitoring and inspection which are done regularly and incidentally by the evaluators will be conducted to maintain product quality and protect consumers. Supervision may be done through cyber patrolling, facility inspection, and from reports sent by the users.
• Sanctions:
  The procedure for imposing administrative sanctions is carried out in accordance with the provisions of the applicable legislation.

Start your e-Commerce Journey!

These guidelines are particularly relevant for medical device manufacturers and distributors looking to sell their medical devices online. Understanding the requirements ensures compliance and contributes to the overall safety of medical devices and health supplies.

Qualtech Consulting Corporation has been a trusted partner for medical device manufacturers for over 20 years. Whether you’re a local startup or an international player, we empower your devices to enhance lives.

Could you connect with us today to unlock your medical device potential?

 

 

References:

GUIDELINES FOR THE CIRCULATION OF MEDICAL DEVICES AND PKRT THROUGH ELECTRONIC SYSTEMS