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Good Cosmetic Manufacturing Practices (CPKB) are all aspects of cosmetic manufacturing activities that aim to ensure that the products produced always meet the quality requirements set according to their intended use. The cosmetics industry is required to implement CPKB guidelines in every cosmetic manufacturing activity. Based on BPOM Regulation No. 25 of 2019, there are 13 aspects of CPKB guidelines that must be implemented by the cosmetics industry:Quality Management System: The company must have a structured quality management system.Personnel: Sufficient personnel must be available, possessing the knowledge, experience, skills, and abilities appropriate to their duties and functions.Buildings and Facilities: Buildings and facilities must be located appropriately, designed, built, and maintained properly.Equipment: Equipment must be designed and placed according to the needs of the product to be manufactured.Sanitation and Hygiene: Sanitation and hygiene must be implemented to avoid contamination during product manufacturing.Production: The production process must be carried out according to established procedures, from raw materials to finished products.Quality Control: Quality control is conducted to ensure that products are made from the correct materials, of high quality, in the appropriate quantities, and under the right manufacturing conditions according to standard procedures.Documentation: All activities must be recorded, including equipment maintenance, storage, quality control, distribution, and other specific matters related to CPKB.Internal Audit: Conduct assessments and tests of all or part of the quality system with the aim of improving the quality system.Storage: Provide appropriate storage facilities to maintain product quality.Contract Manufacturing and Testing: The implementation of contract manufacturing and testing must be clearly established, agreed upon, and supervised to avoid misunderstandings that could affect the quality of the product or work performed.Complaint Handling and Product Recall: A complaint handling and product recall system must be implemented to address issues that may arise after the product is marketed.Reference:PerBPOM No.25 Tahun 2019https://jdih.pom.go.id/download/product/835/25/2019

There are 16 categories of medical devices and in vitro diagnostic medical devices that are limited based on their function and application in the health sector. In accordance with the Regulation of the Minister of Health Number 62 of 2017 concerning Distribution Permits for Medical Devices, In Vitro Diagnostic Medical Devices, and Household Health Supplies, here is a list of these categories:NoCategorySubcategories1Clinical Chemistry and Clinical Toxicology EquipmentClinical Chemistry Test SystemsClinical Laboratory EquipmentClinical Toxicology Test Systems2Hematology and Pathology EquipmentBiological StainsCell and Tissue Culture ProductsPathology Equipment and AccessoriesSpecimen Preparation ReagentsAutomatic and Semi-Automatic Hematology EquipmentManual Hematology EquipmentHematology Packages and KitsHematology ReagentsProducts Used in the Preparation of Blood and Blood-Derived Preparations3Immunology and Microbiology EquipmentDiagnostic EquipmentMicrobiology EquipmentSerology ReagentsImmunology Laboratory Equipment and ReagentsImmunological Test SystemsTumor Antigen Immunological Test Systems4Anesthesia EquipmentDiagnostic Anesthesia EquipmentMonitoring Anesthesia EquipmentTherapeutic Anesthesia EquipmentOther Anesthesia Equipment5Cardiology EquipmentDiagnostic Cardiology EquipmentMonitoring Cardiology EquipmentProsthetic Cardiology EquipmentSurgical Cardiology EquipmentTherapeutic Cardiology Equipment6Dental EquipmentDiagnostic Dental Equipment Prosthetic Dental Equipment Surgical Dental Equipment Therapeutic Dental EquipmentOther Dental Equipment7Ear, Nose, and Throat (ENT) EquipmentDiagnostic ENT EquipmentProsthetic ENT EquipmentSurgical ENT Equipment Therapeutic ENT Equipment8Gastroenterology-Urology (GU) EquipmentDiagnostic GU EquipmentMonitoring GU EquipmentProsthetic GU Equipment Surgical GU Equipment Therapeutic GU Equipment9General Hospital and Personal Equipment (GH & P)Monitoring GH & P EquipmentTherapeutic GH & P Equipment Other GH & P Equipment10Neurology EquipmentDiagnostic Neurology Equipment Surgical Neurology EquipmentTherapeutic Neurology Equipment11Obstetrics and Gynecology (OG) EquipmentDiagnostic OG Equipment Monitoring OG Equipment Prosthetic OG Equipment Surgical OG Equipment Therapeutic OG Equipment Reproductive Assistance Equipment12Eye EquipmentDiagnostic Eye Equipment Prosthetic Eye Equipment Surgical Eye Equipment Therapeutic Eye Equipment13Orthopedic EquipmentDiagnostic Orthopedic EquipmentProsthetic Orthopedic Equipment Surgical Orthopedic Equipment14Physical Health EquipmentDiagnostic Physical Health EquipmentProsthetic Physical Health EquipmentTherapeutic Physical Health Equipment15Radiology EquipmentDiagnostic Radiology EquipmentTherapeutic Radiology EquipmentOther Radiology Equipment16General Surgery and Plastic Surgery EquipmentDiagnostic Surgery Equipment Prosthetic Surgery Equipment Surgery Equipment Therapeutic Surgery EquipmentReference:Permenkes No.62 Tahun 2017https://peraturan.bpk.go.id/Details/112243/permenkes-no-62-tahun-2017

Cosmetics industry manufactures various types and forms of cosmetics according to the Production Permit for Cosmetics granted. The production of cosmetics is categorized into Production Permit for Cosmetics Class A and Production Permit for Cosmetics Class B.Cosmetics Industry Class AClass A Cosmetics Industry is capable of producing all forms and types of cosmetics and has a pharmacist as the technical supervisor.Cosmetics Industry Class BClass B Cosmetics Industry can only produce certain forms and types of cosmetics using simple technology and has a Pharmaceutical Technical Personnel (TTP) as the technical supervisor.According to Regulation No. 8 Year 2021 by the National Agency of Drug and Food Control (Badan POM) regarding Certain Types of Cosmetic Forms that Can be Produced by Class B Cosmetics Industry, Class B Cosmetics Industry is prohibited from producing:Cosmetics for infantsCosmetics for use around the eyes, oral cavity, and/or other mucous membranes;Cosmetics containing substances that function as anti-acne, skin brightening, sunscreen, chemical peeling, and/or hair dye; and/orCosmetics that require high technology in their production, such as aerosols and compact powders.Cosmetics industry must implement Good Manufacturing Practices (GMP) Certification in the production of cosmetics. According to Minister of Health Regulation No. 1175/Menkes/Per/VIII/2010 Article 8 Year 2010, Class A Cosmetics Industry is required to apply GMP, while Class B Cosmetics Industry must implement hygiene, sanitation, and documentation according to GMP.Reference:PerBPOM No.8 Tahun 2021https://jdih.pom.go.id/download/product/1235/8/2021Permenkes Nomor 1175/MENKES/PER/VIII/2010 Tahun 2010 https://peraturan.bpk.go.id/Details/129878/permenkes-no-1175menkesperviii2010-tahun-2010

Symbols on Medical Devices and Household Health Supplies (PKRT) play a crucial role in conveying essential information about their use, risks, and purpose to users. These internationally recognized symbols, mandated by regulatory bodies such as the EU and US FDA, are typically included on labels to denote details like manufacturing date, expiry date, and safety warnings. They help healthcare professionals, patients, and caregivers quickly understand important information, even across language barriers. To ensure clarity, explanations for new or unclear symbols must be provided, often in accompanying manuals or leaflets. Adopting standardized symbols enhances user comprehension, promotes safety, and ensures compliance with regulations, thereby contributing to improved patient outcomes and demonstrating the manufacturer's commitment to user safety and satisfaction.SymbolDescriptionManufacturerIndicates the medical device manufacturer. This symbol is accompanied by the name and address of the manufacturerAuthorized representative in the European UnionIndicates the authorized representative in the European Community. This symbol is accompanied by the name and address of the authorized representative in the European Community.Date of manufactureThis Medical Device Symbols shall be accompanied by a date to indicate the date of manufactureUse-by dateThis Medical Device Symbols shall be accompanied by a date to indicate that the medical device should not be used after the end of the year, month or day shown.Batch CodeIndicates the batch code from the manufacturer, allowing for identification.Catalogue NumberIndicates the catalogue number associated with the device, allowing the medical device to be identified.Serial NumberIndicates the serial number from the manufacturer, allowing a specific medical device to be identified.SterileIndicates that the product has undergone a sterilization process.Sterilized using irradiationIndicates a medical device that has been sterilized using irradiationSterilized using steam or dry heatIndicates that the product has been sterilized using steam or dry heat.Do not resterilizeIndicates that the medical device should not be resterilized.Non-sterileIndicates that the medical device has not undergone a sterilization process.Do not use if the packaging is damagedIndicates that the medical device should not be used if the packaging is damaged or opened.For further details, you can access the guidelines at the following link: https://regalkes.kemkes.go.id/informasi_alkes/008.%20Pedoman%20Penandaan%20ALKES.pdf, specifically pages 31-36.

The supervision of advertisements for medical devices and household health supplies (PKRT) circulating in the community must be conducted in accordance with the applicable marketing authorization. In its implementation, advertisements for medical devices and PKRT must provide objective, comprehensive, and non-misleading information. Advertisements must include information on benefits, contraindications, side effects, and other relevant information regarding product use, and must be honest, accurate, and responsible, without exploiting public health concerns. In accordance with the Republic of Indonesia Consumer Protection Law Number 8 of 1999, businesses are prohibited from offering, promoting, or advertising goods and/or services incorrectly or using exaggerated terms such as "safe," "harmless," or "risk-free" without complete information.Advertising materials for medical devices and PKRT as regulated in the Minister of Health Regulation Number 76 of 2013, Article 7, are not permitted if:Misleading through emphasis, striking comparisons, or omission of factsCompares with other similar products with the intention of denigrating;Directly or indirectly encouraging excessive and unnecessary use of health devices and PKRTExploits public ignorance by including unverifiable and unverified scientific dataCreates fear or exploits myths that exist in the communityProvides testimonialsUses names, initials, logos, symbols, and/or references indicating endorsement from health-related institutions or organizationsUses confusing medical jargon/slogansMisuses research findings or quoting from technical or scientific publications; and/or Directly or indirectly suggesting prevention of diseases.In addition to the provisions stipulated in Article 7, advertisements for Medical Devices are not allowed if they:Contain words, phrases, or illustrations claiming or suggesting that they can cure a disorder or diseaseDirectly or indirectly suggest that the medical device can prevent, slow down, or reverse physiological changes and degenerative conditions related to agingMake various claims or impressions that the Medical Device is perfect or guarantees definite recoveryNeglect primary treatment/care, offer specific advice, diagnosis, or treatment for serious and chronic diseases.Reference:Permenkes No. 76 Tahun 2013https://regulasi.bkpk.kemkes.go.id/detail/7e3898f8-ad80-4f01-b248-645a6e36712e/Undang-Undang No. 8 Tahun 1999https://drive.google.com/file/d/12b_j4tcAgorqJ39RxWrMIcFs-mUjt0l-/preview

Cosmetics are one of the commodities that are widely traded online through social media or e-commerce. This condition provides a more dominant space for advertising as a means for business actors to convey product information to the public, so that published cosmetic advertisements must be in accordance with the information data in the notification. On the other hand, the very dynamic development of advertising demands the existence of rules that can be used as a reference for advertising in a healthy, objective, honest, correct, and responsible manner and comply with the ethics and norms that apply in society. Information on promotional materials/cosmetic advertisements in circulation must meet the criteria as stipulated in BPOM Regulation Number 32 of 2021 concerning Supervision of Cosmetic Advertising. The information contained in the Advertisement must meet the following criteria:Objective, provide information that aligns with the actual facts and must not deviate from the utility, method of use, and safety of the cosmetics.Not misleading, deliver information that is honest, accurate, and responsible, and does not exploit public fears.Must not imply as medicine, not stating as if it were a medicine or intended to prevent a disease.General guidelines for cosmetic advertising information include:Must not contradict public morality and orderMust not use flags, national symbols, and/or national anthemsMust not depict national heroes and/or national monuments inappropriatelyMust not display any form of discriminationMust not denigrate other companies or productsMust not xxploit eroticism or sexualityMust not support, justify, and/or tolerate acts of violenceMust not exploit misfortune, suffering, and/or public anxietyMust not arouse or play on fear, or exploit public superstitionReference:Peraturan BPOM No. 32 tahun 2021https://jdih.pom.go.id/download/product/1336/32/2021

In BPOM Regulation Number 12 of 2019 concerning Contamination in Cosmetics, what is meant by Contamination is something that enters cosmetics unintentionally and cannot be avoided which comes from the processing, storage and/or carried from raw materials. There are three types of contaminants contained in hazardous cosmetics, namely:Microbial Contamination, namely the presence of microbes in cosmetics that can be detrimental and dangerous to human health, such as total plate counts, mold and yeast counts, Pseudomonas aeruginosa, Staphylococcus aureus, and Candida albicans.Heavy Metal Contamination, namely metallic and metalloid chemical elements, has a high atomic weight and specific gravity, and is toxic to living things. To find out heavy metal contamination in cosmetics can only be done through laboratory testing, including using the Atomic Absorption Spectrophotometry (AAS) or Inductively Coupled Plasma (ICP) methods. In the Regulation of the Head of POM Agency Number 17 of 2014, it is explained that the requirements for heavy metal contamination in cosmetics for: Mercury (Hg), must not be more than 1 mg/kg or 1 mg/L (1 bpj) Lead/Black Lead (Pb), must not be more than 20 mg/kg or 20 mg/L (20 bpj) Arsenic (As), must not be more than 5 mg/kg or 5 mg/L (5 bpj) Cadmium (Cd), must not be more than 5 mg/kg or 5 mg/L (5 bpj) Chemical Contamination, which is a hazardous substance from chemical elements or compounds that can harm and endanger human health, for example 1,4- Dioxane. The content of 1,4-dioxane is known to be carcinogenic if used in the long term.Contaminant testing must be conducted in laboratories using validated or verified analytical methods. Business operators must ensure that cosmetics produced for domestic distribution and/or imported for distribution in Indonesia meet safety, efficacy, quality, labeling, and claims requirements. Business operators are required to document the testing results in the Product Information Document (PID).Reference:Peraturan Badan POM Nomor 12 Tahun 2019https://notifkos.pom.go.id/upload/informasi/20190923110116.pdfPeraturan Kepala Badan POM Nomor 17 Tahun 2014https://jdih.pom.go.id/download/product/695/17/2014

Medical devices have risks ranging from low risk to high risk that can potentially cause serious injury, to permanent disability and even death. Therefore, medical devices used in health services must be ensured to be safe, quality, and beneficial. To ensure safety, quality, and benefits, each medical device must first go through a pre-market evaluation process. In accordance with the provisions of the Asean Medical Device Directive (AMDD), medical devices are classified based on the risks posed during the use of the medical device. Based on these risks, medical devices are divided into four classes as follows:Class A poses low risk, for example Film viewer, surgical gloves, oxygen mask.Class B poses low to moderate risk, for example blood pressure cuff, steam sterilizer.Class C poses moderate to high risk, for example patient monitor, x-ray machineClass D poses high risk, for example heart stent, pacemaker.There are factors that influence the classification of medical devices. The classification of medical devices is influenced by the following factors:Length of contact time of the device with the body Degree and place of entry into the body Combination of medical devicesIntended use as a diagnostic tool or for maintenance Local effects on the systemicMechanism of action in the bodyBiological effects on the body (if appropriate)Contact with injured skin (if appropriate)Ability of the device to be reused or notThe applicant for the distribution license must independently determine the risk class according to the type of product to be insured. If a medical device is designed to be used in combination with other medical devices, each of those devices must be classified separately. The Ministry of Health has developed a new feature called SIKLARA (https://siklara.kemkes.go.id/), which functions to independently identify the risks of medical devices according to the risk classification stipulated in AMDD. Currently, SIKLARA is still under development and primarily functions as a supplementary tool for classification.Reference:Permenkes No. 62 Tahun 2017https://regalkes.kemkes.go.id/informasi_alkes/PMK_No_62.pdfSIKLARA Guidebookhttps://siklara.kemkes.go.id/file/Pedoman.pdf