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Medical devices that do not meet standards and/or requirements may be subject to sanctions in the form of an order to withdraw from circulation and then be destroyed. The withdrawal of Medical Devices aims to protect the public from Medical Devices that can endanger the safety and health of users or the public. Producers, Distributors and Importers are responsible for implementing the withdrawal and destruction of medical devices that do not meet the requirements.The recall of medical devices is carried out on medical devices and household health supplies with the following criteria:Does not meet the requirements for safety, quality and efficacy for useHas expiredIllegal products (fake or do not have a distribution permit)The distribution permit is no longer validProduced and/or imported not in accordance with the provisions of laws and regulationsProduced, imported and distributed have the risk of causing disease and injury; and/orLabeling that does not comply with the approved permit, according to the risk analysis of the impact on healthThe types of recall actions for Medical Devices are classified based on the identification of the impact of health risks to users. The classification is divided into 3 (three) classes:High risk, is a recall action carried out if the product is identified as having damage that is potentially life-threatening and causes serious health risks.Medium risk, is a recall action carried out if damage is identified to the product that causes disease or maintenance errors but poses a medium risk.Low risk, is a recall action carried out if damage is identified to the product that does not endanger health but requires a recall and the resulting risk is a low risk.Reference:Regulation of the Director General of Pharmaceuticals and Medical Devices on Procedures for the Recall and Destruction of Medical Devices and Household Health Supplieshttps://link.kemkes.go.id/PenarikanAlkes

The Certificate of Good Medical Device Distribution Practices (CDAKB) is important to prevent the entry of substandard and counterfeit medical devices into the medical device supply chain in the community. In order to support the acceleration of safe business licensing from Law No. 11 of 2020 concerning Job Creation, since mid-2022, several changes have been made to the CDAKB certification process, one of which is self-assessment. The purpose of the self-assessment is for companies to be able to conduct an independent initial assessment of the implementation of CDAKB. To access the self-assessment facility and other certification processes, users must first register an account on the Online Single Submission (OSS) system.CDAKB Certification Application Process:Account Registration: Business actors must be registered in the OSS RBA system and have a standard certificate or a distribution permit for medical devicesLogin and Form Filling: Log into the OSS RBA system, select the PB UMKU menu corresponding to KBLI code 46691, then click the "Fulfillment of Requirements" button in the Ministry/Agency (K/L) systemDocument Submission: Switch to the Seralkes system, select the CDAKB menu, and upload the required documents.Document Review: The submitted documents will be reviewed by the relevant authorities.Audit Scheduling: The audit will be scheduled after the document review is completedAudit Process: The audit is conducted through a Site Visit to evaluate whether all aspects of distribution and quality control for medical device distributors meet CDAKB regulations.PNBP Payment: Business actors must make the payment for Non-Tax State Revenue (PNBP).CAPA Process: After the audit, any evaluation findings requiring corrections must be addressed through Corrective Action Preventive Action (CAPA) in the OSS system.Resume Creation: The resume and technical data attachments are prepared in the Seralkes system.Certificate Issuance: The CDAKB certificate is issued through the OSS RBA system once all requirements are fulfilled.

A medical device distributor branch is an extension of a central health equipment distributor, authorized to distribute or deliver medical devices. To establish such a branch, specific documents and requirements, similar to those for the central office, must be met. These branches operate under the guidelines set by the Ministry of Health Regulation No. 14 of 2021.General RequirementsLegal Entity: The branch must be part of a legal entity, like a limited liability company (PT) or a cooperative.Payment Proof: Provide proof of payment for Non-Tax State Revenue (PNBP).Distribution License: Hold a central distribution license for medical devices.CDAKB Certificate: Have a Certificate of Good Distribution Practice for Medical Devices (CDAKB) from the central authority.Technical Responsible Person: Submit data on the technical responsible person for the branch.Compliance Statement: Submit a statement confirming readiness to comply with CDAKB standards.Timeline: Complete all requirements within one year of application approval on the Online Single Submission (OSS) platform.To operate, a branch needs:A Distribution License for Medical Devices (IDAK) from the central authority.A branch-specific CDAKB certificate from the central authority.Specific RequirementsTraining: The technical responsible person must have a CDAKB training certificate.Business Plan: Develop an operational business plan, detailing the product types to be distributed and available storage facilities.Technicians and Workshops: Provide technicians and workshops for distributing electromedical and in vitro diagnostic instruments.Nuclear Energy Permit: If distributing electromedical radiation devices, obtain a permit from the Nuclear Energy Regulatory Agency (BAPETEN).Meeting these requirements ensures the branch can effectively distribute and deliver medical devices according to approved standards.References:https://peraturan.bpk.go.id/Details/203315/permenkes-no-14-tahun-2021

In 2018, the Indonesian Government introduced Government Regulation Number 24 of 2018 concerning the Integrated Electronic Business Licensing Services, known as OSS (Online Single Submission) (https://oss.go.id/portal/). OSS aims to streamline the business licensing process, accelerate capital investment, and enhance societal welfare. It debuted with OSS Version 1.0 in 2019, designed to simplify the management of various permits, including business and operational licenses. Through OSS, businesses can apply for licenses via an efficient and integrated online platform. The implementation of OSS is regulated by Government Regulation Number 24 of 2018, which stipulates that business permits submitted before this regulation came into effect and not yet issued will be processed through OSS. Previously issued permits or those requiring new permits for business expansion will also be handled through OSS.OSS is utilized for managing business permits by entities ranging from corporations to individuals, and micro, small, medium, and large enterprises. It facilitates both new and pre-existing businesses under OSS, whether entirely domestic or with foreign investment components. The public can access the OSS system online anytime and anywhere. OSS serves as the sole gateway for all types of businesses seeking operating permits in Indonesia, including local and foreign investment companies, individual entrepreneurs, corporate entities, and micro, small, medium, and large enterprises. The exception applies to activities in the financial, mining, oil, and gas sectors.Benefits of using OSS:Facilitates the management of various business licenses, including prerequisites for conducting business (location, environmental, and building permits), business licenses, and operational permits for business activities at both central and regional levels with a mechanism for fulfilling permit requirements.Enables business operators to connect with all stakeholders and obtain permits safely, quickly, and in real time.Facilitates business operators in reporting and resolving licensing issues in one place.Enables business operators to store licensing data under one business identity (NIB).Reference:https://www.ini.id/apps/public/file/peraturan/peraturan-pemerintah-nomor-24-tahun-2018.pdf

The Surveyor Report, also known as the Certificate of Inspection, is a document stating that goods have been inspected and meet the requirements at the time of examination. This document is generally required in international transactions, especially for consumer goods such as electronics, luxury items, clothing, hardware, and oil. The Surveyor Report confirms that the goods have been verified by an authorized institution in accordance with the transaction contract terms, ensuring compliance from all involved parties, enhancing importers' confidence and trust, and reducing the risk of losses in the transaction process.The surveyor report for imported goods is crucial for importers as it ensures that the received goods' quality complies with standards set by the local government. Moreover, this report facilitates the process of customs duties and import taxes payment.According to Regulation No. 16 of 2021 on Verification or Technical Tracing in Foreign Trade, the Surveyor Report as referred to in Article 10 is used as: a. a customs supplementary document inspected within the customs area; and/or b. an import requirement document inspected after passing through the customs area (post-border).To process the surveyor report for imported goods, importers need to submit an application to the surveyor or quality inspection institution designated by the government. The application process can be done online or by visiting the designated institution's office. Subsequently, the surveyor or quality inspection institution will inspect the imported goods. Once the inspection is completed, the surveyor report for imported goods will be issued and handed over to the importer.Reference:Permendag No. 16 Tahun 2021https://jdih.kemendag.go.id/pdf/Regulasi/2021/Permendag%20Nomor%2016%20Tahun%202021.pdf

Frozen foods, such as nuggets, meatballs, and sausages, are processed foods that are frozen and must be kept at -18°C throughout their distribution and storage to remain safe and edible. According to Law Number 18 of 2012 on Food and Government Regulation Number 86 of 2019 on Food Safety, all processed foods sold must have a distribution permit. This ensures that food management is thorough from production to sale, including safety, quality, and nutrition, guaranteeing that the products on the market meet the safety standards set by the authorities.Therefore, to ensure widespread acceptance and compliance with safety standards, business operators must obtain permits from the Food and Drug Monitoring Agency (BPOM).The following types of processed foods, including frozen foods, must have a distribution permit from BPOM:Foods with Added Nutrients: Such as special foods for pregnant women, infants, and toddlers, and processed foods that claim to be rich in vitamins or minerals.Processed Foods Requiring Indonesian National Standards (SNI): Including iodized salt, wheat flour, cocoa powder, bottled drinking water, white crystal sugar, and canned fish.Government Program Foods: Foods intended for government initiatives.Foods for Market Testing: Products meant for market testing.Foods with Additives (BTP): Products containing specific food additivesHowever, certain frozen foods do not require a distribution permit from BPOM:Shelf Life Less Than Seven Days: Products that have a shelf life of less than seven days when frozen and are made to order.Used as Raw Materials: Products intended to be further processed and not sold directly to consumers.Packaged and Sold Directly: Products packaged and sold directly in front of the buyer in small quantities based on consumer requests.Ready-to-Eat Foods: Processed foods that are ready to eat and can be temporarily stored at frozen temperatures.

Important Changes and Compliance Requirements for Medical Device DistributorsIn accordance with Government Regulation Number 5 of 2021 regarding the Implementation of Risk-Based Business Licensing and the Minister of Health Regulation Number 14 of 2021 concerning Standards for Business Activities and Products in the Implementation of Sector Risk-Based Business Licensing in the Health Sector, a new announcement has been made to ensure compliance with current regulations.Key Points of the Announcement1. Mandatory Business License Number (NIB)Every medical device distribution business is required to obtain a Business License Number (NIB) under KBLI 46691. This classification pertains to the wholesale trade of laboratory equipment, pharmaceutical equipment, and medical devices for humans, covering distributors and branches of medical device distributors. The standards regulating these requirements are crucial for conducting business in this sector.2. Adjustment of Existing LicensesBusiness actors currently holding a Medical Device Distributor License (IPAK) under the Minister of Health Regulation Number 1191/MENKES/PER/VIII/2010 of 2010 concerning the Distribution of Medical Devices must update their permits to align with the new regulations.3. Submission of IDAK ApplicationsIDAK applications should be submitted through the OSS RBA system accessible via the official website www.oss.go.id. This system is integrated with the Regalkes system according to the Single Sign On (SSO) mechanism.4. Application ProceduresDetailed procedures for submitting applications via the OSS system can be found at https://oss.go.id/panduan. Additionally, materials related to fulfilling IDAK requirements are available at https://drive.google.com/drive/folders/1ltHUcOHnuvQCDSyzul1FODFVf8a1JiDX5. CDAKB Certification RequirementEvery medical device distributor is required to have a CDAKB (Good Distribution Practices for Medical Devices) certificate in accordance with the Minister of Health Regulation Number 14 of 2021.This announcement serves as a crucial reminder for all medical device distribution business actors to review and adjust their compliance practices according to the latest regulations. Ensuring that all necessary permits and certifications are up to date is essential for the continued operation and legality of their business activities.For further details and guidelines, business actors are advised to refer to the provided resources and links. Compliance with these updated regulations will not only ensure adherence to legal standards but also contribute to the overall safety and quality of medical device distribution.Reference:https://regalkes.kemkes.go.id/index.php/home/fileDownload/BERITA_FILE.pdf/1000934

The Halal Product Assurance Organizing Agency (BPJPH) of the Ministry of Religious Affairs invited numerous business associations and importers to discuss critical issues related to the mandatory halal certification for products entering, circulating, and traded in Indonesia, set to take effect in October 2024."We invited the leaders or representatives of business associations and importers for a joint discussion to address various matters related to the implementation of the mandatory halal certification, which will be phased in starting October 2024," said Abd Syakur, Head of the Center for Halal Cooperation and Standardization, after leading the Focus Group Discussion (FGD) at the Oakwood Hotel, East Jakarta, today, Tuesday (June 11, 2024). The FGD included BPJPH Secretary E.A. Chuzaemi Abidin, Head of Halal Registration and Certification Siti Aminah, and representatives from various associations such as APINDO, HIPPINDO, AFFI, and GAPMMI, among othersSyakur elaborated that through this FGD, BPJPH, as the government agency responsible for organizing Halal Product Assurance (JPH), aims to ensure a mutual understanding of JPH regulations and their technical implementation between the government and the industry in a harmonious and equitable manner. Besides serving as a platform for disseminating JPH policies and regulations, the FGD also functions as a medium to gather input from business actors."This constructive discussion aims to mitigate issues and foster a conducive environment to ensure the smooth implementation of mandatory halal certification, including aspects related to the registration of foreign halal certificates. The objective is for the implementation to run smoothly and, hopefully, for the continuity of the supply chain to improve," Syakur continued.Reference:https://bpjph.halal.go.id/detail/bpjph-undang-asosiasi-usaha-dan-importir-diskusikan-pemberlakukan-wajib-halal