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The era of globalization has led to ease in and out of the goods including medical devices and household-health product. Rapidly growing technology of medical devices cause people frequently need either information for personal needs, company, or public facility. Product information is also required in doing export import of medical devices and household-health product to perform the registration process. To meet the public's information needs, the Directorate of Medical Devices and Household Health Products offers a streamlined certification service via the ESUKA platform. Available at http://esuka.binfar.kemkes.go.id, ESUKA (e-System for Medical Device and Health Product Certificates) simplifies and manages the certification process effectively. ESUKA aims to enhance efficiency by facilitating access to information through a well-managed certification service, ensuring that the process runs effectively and efficiently.Type of CertificateThe Directorate General of Pharmaceutical and Medical Devices, through its Directorate of Medical Devices and Household Health Products, issues various certificates, including:Certificate of Free Sale (CFS)Certificate of ExportationHealth CertificateSpecial Access Scheme (SAS)Certificate of Sample Importation for Marketing AuthorizationCertificate of Importation of Raw MaterialsCertificate of Importation of Spare PartsCertificate of Product Information for Companies/IndividualsCertificate of Importation (Customs)Certificate of Importation AuthorizationCertificate of Advertisement ApprovalCertificate of PromotionalCertificate of Recommendation for Importation ApprovalOther Information CertificatesCost of Certificate Service ProcessThe process of certificate service is divided into two stages: initial evaluation and final evaluation. After completion of the initial evaluation, the applicant will receive payment instruction of Nontax state revenue according to applicable regulationSources: Guidelines for Medical Device and Household Health Product Certificates (Bilingual)https://regalkes.kemkes.go.id/informasi_alkes/015.%20Pedoman%20Surat%20Keterangan%20Alat%20Kesehatan%20dan%20PKRT%20Bilingual.pdf

General RequirementsThe requirements for medical device registration must be submitted using the following five forms:Form A: AdministrationForm B: Product InformationForm C: Product Specifications and Quality AssuranceForm D: Usage and Instructions for UseForm E: Post Market Surveillance SystemDistribution Permit Application ProcessMedical device registration applications are submitted electronically through the website http://www.regalkes.depkes.go.id. The registration stage involves evaluating and verifying the safety, quality, and benefits of medical devices.Form Submission: The applicant fills out and submits the application form onlinePNBP Payment: The applicant receives a PNBP Payment Order (SPB) according to the medical device class and must make payment and upload proof of payment within 10 days after receiving the pre-registration notification.Payment Verification: The PNBP Admin will verify proof of payment and send a fixed receipt to the applicant.File Evaluation: The Assessment Team evaluates and verifies application files online.Evaluation Results: Results are provided via the company account on the registration site or email, and may include approval, deficiency notifications, or rejection.File Processing: Complete files are processed for permit approval.Correction of Deficiencies: Applicants have 10 days to correct deficiencies for class A, B, C and 15 days for classes D.Re-evaluation: Corrections are re-evaluated within 10 days for class A, B, C, and 15 days for classes D.Rejection: If deficiencies are not corrected, a Rejection Letter is issued, and the applicant must reapply. PNBP fees are non-refundable for rejected applications.Service Time and CostThe time and cost for a medical device distribution permit depend on the device class and start from the issuance of a receipt after payment verification.KelasRegistrasiBiaya1A60 Hari KerjaRp 1.500.000,-2B60 Hari KerjaRp 3.000.000,-2C60 Hari KerjaRp 3.000.000,-3D85 Hari KerjaRp 3.000.000,-Note: The PNBP fee for the application for a distribution permit for medical devices is in accordance with applicable provisions.Source:Pedoman Bimbingan Teknis Perizinan Alat Kesehatan (https://farmalkes.kemkes.go.id/unduh/pedoman-bimbingan-teknis-perizinan-alat-kesehatan/)

The Halal Product Assurance Agency (BPJPH) of the Ministry of Religious Affairs emphasizes that the obligation for halal certification applies according to the Halal Product Assurance (JPH) regulations for various products, including goods and services. The services required to have halal certification include slaughtering, processing, storage, packaging, distribution, sales, and serving, particularly for food, beverages, medicine, and cosmetics. These regulations are outlined in Government Regulation PP 39/2021 and the Head of BPJPH Decree No. 20 of 2023, which amends the Head of BPJPH Decree No. 57 of 2021 concerning the Criteria for the Halal Product Assurance System.Halal certification for logistics services related to food, beverages, medicine, and cosmetics applies only to third parties providing logistics services without producing goods. Businesses with their own storage, packaging, and distribution facilities do not need to apply for separate logistics service certification, as their product certification already covers the internal logistics aspects of their company. BPJPH Head Muhammad Aqil Irham clarifies that there is a misunderstanding circulating that vehicles, such as trucks, need halal certification. According to the regulations, the requirement is for halal certification of logistics services, not for transportation vehicles.“Thus, I emphasize this to correct the misunderstanding that trucks or transport vehicles must be halal certified. According to the regulation, it is the logistics services that must be halal certified." Aqil explained in Jakarta, Thursday (5/9/2024)."In principle, the guarantee of halal products must meet the principle of product traceability, from the beginning of production until the product is received by consumers. Therefore, it must be ensured that in all aspects, the halal product process meets the established standards, and is ensured to be free from potential contamination from non-halal materials." Aqil continued to explain.Although halal, non-halal, and non-halal products can be distributed in the same facility, there are special requirements that must be met. For example, for fresh products or frozen animal products, distribution facilities must be separate. In addition, distribution service business actors are required to ensure that there is no cross-contamination during the distribution process. Government Regulation Number 39 of 2021 regulates in detail the provisions regarding the distribution of halal products, ensuring that every business actor carries out the distribution, sales, and presentation of products in accordance with applicable regulations.Source:https://bpjph.halal.go.id/detail/bpjph-tegaskan-sertifikasi-halal-untuk-jasa-pendistribusian-bukan-kendaraan-pengangkut

A Distribution Permit Number (NIE) is an official license issued by the relevant authorities to distribute products in the market. The NIE ensures that the product meets the applicable standards and regulations before it can be marketed. Certain significant changes to a product may require the NIE holder to register a new distribution permit number. The following are criteria for changes that may affect the NIE:Product Size, An increase or decrease in the content and/or size of the product may affect the NIE.Packaging:An increase or decrease in packaging size.An increase or decrease in the type of packaging.A change in the design of the packaging shape.A change in packaging materials.Labeling:A change in the language used in the instructions for use and/or packaging.A change in logos/symbols, such as halal logos or company logos.A change in the expiration date if listed on the labeling.A change in the product code/type.A change in storage temperature.A correction to the product name.A change in the labeling design, including color, images, text, and layout.Accessories/Attachments in the Distribution Permit, A change in accessories, type, product code, or product size listed in the distribution permit.Name and/or Address of Related Entities:A change in the name and/or address of the legal manufacturer.A change in the legal entity.A change in the manufacturer's address due to city planning changes.A change in the manufacturer's name as long as the factory's address remains the same or does not relocate.A change in the distributor's (supplier's) name if the NPWP and NIB remain unchanged.A change in the distributor's (supplier's) address if relocating to a different province.Changes That Require a New NIE Registration: In addition to the criteria above, the following changes also require the NIE holder to register a new distribution permit number:Change in Product NameChange of Distributor or NIE HolderChange of Manufacturer/ProducerChange in Manufacturer/Producer LocationChange in Product SpecificationsChange or Addition of Raw Materials/Formula That Alters Specifications/FunctionsChange in Production ProcessChange in Claims or IndicationsReference:Materi Coaching Clinic Industri Alkes Kelas C dan D Dalam Rangka Pre Market Sesuai Janji Layanan Dalam Menjamin Keamanan Mutu dan Manfaathttps://drive.google.com/drive/folders/1yzwLtbDPuWphQ6mbpRqvSH_PWIsxp7GE

On November 24, 2019, the Indonesian government issued Government Regulation No. 80 of 2019 concerning Electronic System Trading (PP PMSE). This regulation addresses crucial aspects of e-commerce in Indonesia, provides a legal framework for electronic trading, and ensures that products sold online meet established standards. Specifically for medical devices, this regulation requires a registration number or notification number from the Ministry of Health as proof that the products meet the prescribed safety and quality standards. This ensures that consumers can have greater confidence in the safety and authenticity of medical products purchased online.The criteria for medical device products that can be distributed through PPMSE are as follows:The product can be used independently by the general public (without professional assistance) and does not require special skills. Examples include: body scales, menstrual pads, and toothbrushes.The product does not pose a high risk due to its use. Examples include: massage chairs and heating pads.The product does not pose a high risk due to misinterpretation of test results. Examples include: pregnancy test strips and rapid blood glucose meters.Optical medical device products can be distributed through electronic systems with the following criteria:Can be used independently without the help of healthcare professionals.Does not require invasive procedures for use.Does not require advanced technology for use and interpretation.Does not require healthcare professionals to interpret the results..List of medical devices that can be distributed through PPMSE electronic systems includes:In vitro diagnostic self-testing devices such as cholesterol meters, blood glucose meters, and uric acid meters.Home use medical devicesElectric massage devices/therapeutic massagersHot/cold compressesHeating padsCane pads, canes, walkers, and mechanical walkersBedpansDental floss and floss picksCold packs/compress plastersContinuous positive airway pressure (CPAP)Neck bracesFlotation cushionsHand carriersHernia supportsHot or cold disposable packsMedical insolesGlasses and lensesIce compress bagsGauze, gauze dressings, and medical spongesCondomsContact lensesManual wheelchairsLimb orthoses/arm supportsLubricantsMedical masksMenstrual cupsMoist heat packsPost-operative eye protectorsNipple protectorsMenstrual padsDenture cleanersContact lens cleanersTongue cleanersBlood pressure monitorsElastic bandagesBedpansMedical adhesive tape and bandagesPlasters and wound dressingsManual and electric breast pumpsAdult diapersPulse oximetersToothbrushes and electric toothbrushesGalvanic spa devicesPregnancy test strips/test packsTamponsHand-carried stretchersTeethersTeething ringsManual bedsDisposable medical bedsThermometersInfusion polesBody scalesTruncal orthosesReference:Guidelines for the Circulation of Medical Devices and Household Health Supplies through Electronic Systems

In accordance with Indonesian regulations, all products entering, circulating, and being traded within Indonesia must have halal certification. This requirement extends to various goods and services, including food, beverages, pharmaceuticals, cosmetics, chemical products, biological products, genetic engineering products, and items used by the public. Consequently, medical devices, as items utilized by society, must also be certified halal.Medical devices that require halal certification are those that originate from or contain animal-derived components. If a medical device contains forbidden substances, is made from non-halal sources, or is produced using processes that do not meet halal standards, the product must indicate its non-halal status. This indication involves providing information about the origin of materials on the device’s labeling. The details are as follows:a. Medical Devices with Ingredients That Are Forbidden and Not Sourced from Halal MaterialsFor medical devices containing forbidden ingredients or materials not sourced from halal sources, the non-halal label must display the name of the ingredient in a different color that is easily visible, readable, and resistant to removal, detachment, and damage. Forbidden materials include carrion, blood, pork, and/or animals slaughtered in a manner not compliant with Islamic law. An example of how to label this information is as follows:In Indonesia : “Bahan tidak halal”In English : “Non-halal ingredients”b. Medical Devices with Halal Ingredients but Produced with Non-Halal ProcessesFor medical devices made from halal ingredients but manufactured using non-halal processes, the non-halal label must indicate the origin of the materials with the ingredient name in a different color that is easily visible, readable, and resistant to removal, detachment, and damage. Such devices are made with materials that have halal certification but involve the use or contact with forbidden materials during the manufacturing process. An example of how to label this information is as follows:In Indonesia : “Proses belum halal”In English : “Process not halal yet”Reference:Regulation of the Minister of Health of the Republic of Indonesia Number 3 of 2024(https://farmalkes.kemkes.go.id/unduh/permenkes-3-2024/)

The newly implemented Regulation Concerning the Control of Drug and Food Online Number 14 of 2014, effective August 5, 2024, allows business actors to distribute cosmetics online using either their own electronic system or one provided by PSE/PPMSE. PSE includes individuals, state organizers, business entities, or communities that provide, manage, or operate electronic systems independently or collectively for their own or others' needs. Conversely, PPMSE refers to business actors who provide electronic communication facilities for trade transactions. Business actors managing online drug distribution must also hold a certificate of good distribution practice for drugs.Electronic System RequirementsThe electronic systems used for the online distribution of drugs and food must comply with the following requirements:Provide accurate information including:The name, address, or identity of the business actor, clearly and traceably.Data and/or information on product labels or markings, including written descriptions or images, in accordance with regulatory standards.Display the drug and food registration number.Feature a traceable mechanism for recording and documenting electronic transactions, and provide access to all users and regulators as per legal requirements.Delivery ObligationsBusiness actors and/or third parties involved in the delivery of drugs, herbal medicines, quasi-drugs, health supplements, cosmetics, processed foods, and/or PKMK must:Ensure that the product packaging remains intact and undamaged throughout the delivery process until it reaches the recipient.Deliver products in sealed containers to maintain integrity.Maintain appropriate delivery conditions based on the characteristics of the product.Confirm that the product reaches its designated destination.Document the transfer of products, including transactions involving third parties, to ensure accurate delivery records to the public.Prohibited Behaviors for Online Cosmetic OperatorsBusiness operators are prohibited from directly distributing or advertising specific drugs and cosmetics through electronic systems to the public. The prohibited items for direct online distribution are as follows:Drugs:Narcotics and psychotropic substances.Injectable forms, excluding insulin for personal use.Contraceptive implants.Cosmetics:Skin care products containing alpha hydroxy acid (AHA) in concentrations exceeding 10%Teeth whitening products containing or releasing hydrogen peroxide at concentrations above 6%.Refillable cosmetics, which are repackaged according to consumer requests at refill facilities.Reference:https://jdih.pom.go.id/download/product/1592/14/2024

ISO 13485 is a quality management system (QMS) standard designed specifically for the medical device industry. This standard proves that the design and production processes of medical devices have met the requirements to ensure the safety and consistent performance of the product. ISO 13485 was originally developed from ISO 9001, but with several important differences such as increased documentation and a focus on risk management, work environment, and regulatory compliance. The latest version of this standard is ISO 13485:2016, which replaces ISO 13485:2012. In Indonesia, the Good Manufacturing Practices for Medical Devices (CPAKB) guidelines also refer to this standard, aiming to ensure the safety, quality, and benefits of medical devices.ISO 13485 applies to organizations involved in various stages of the medical device life cycle, including design, production, installation, and related services. In addition, certification bodies and other external parties can also use it for audit processes. This standard ensures complete recording and control of the process, including if some stages are carried out by third parties. ISO 13485 not only helps organizations meet regulations, but also provides clear guidance in maintaining consistent quality of medical products, making it a vital component in the medical device industry.To obtain ISO 13485 certification, companies must go through a series of processes that include initial assessment, internal team formation, training, and internal audits before submitting to an accredited certification body, such as KAN, UKAS, or ANAB. Although many companies already have ISO 9001, ISO 13485 certification is still needed because it contains specific requirements that are important for the medical device industry. Implementing this standard helps companies adapt to the rapid development of medical technology and ensure that the products produced meet high quality standards.Benefits of Implementing ISO 13485ISO 13485 offers a variety of benefits, including:Meeting regulatory requirements in the medical device sector.Reducing unexpected risks during the process.Gaining international recognition through third-party certification.Providing a competitive advantage in the global market.Facilitating continuous process control and improvement.