Indonesia Medical Devices Regulation QA
HLF-ID-10
What are the categories of medical devices in Indonesia? What is its official name?
What is the intensity of management of different categories?
What is the governmental authority of medical devices? Website?
Evershine RD：
In Indonesia, medical devices are regulated by the Ministry of Health (MoH) responsible for pre-market and post-market assessment, standardization, legislation and Good Manufacturing Practice (GMP) certification.
Prior to importation, medical devices and in vitro diagnostic medical devices (IVDs) must obtain a registration number and a product license issued by the Ministry of Health to the local franchised distributor.
1. Medical Devices: Instruments, devices, machines and/or implants used to prevent, diagnose, cure and alleviate disease, treat patients, restore human health and/or form structures, improve bodily functions, but do not include drugs.
Medical devices can be used in humans, alone or in combination, for one or more of the following purposes:
．Diagnose, prevent, monitor, treat or reduce disease.
．Diagnosis, monitoring, treatment, mitigation or compensation of a disease condition.
．Investigation, replacement, modification, anatomical support or physiological process.
．Support or sustain life.
．Block fertilization.
．Medical device disinfectant.
．Provide information for medical or diagnostic purposes by performing in vitro testing on specimens and humans.
2. In vitro diagnostic medical device: reagents, calibrators, control materials, kits, instruments, devices or systems, used alone or in combination, for the examination of any in vitro specimen (including blood or tissue of human origin), primarily for the purpose of To provide one or more of the following information:
．Physiological or pathological conditions or congenital abnormalities.
．Determine safety and suitability for blood or tissue donors and potential recipients.
．Monitor the status of treatment.
3. Therapeutic Active Medical Devices: Active medical devices, used alone or in combination with other medical devices, to support, modify, replace or improve biological function or structure, to treat or reduce disease, injury or disability.
4. Diagnostic Active Medical Devices: Active medical devices, used alone or in combination with other medical devices, to detect, diagnose, monitor or assist in the treatment of physical conditions, fitness levels, diseases or congenital disabilities.
5. Active medical device: Medical device that operates with energy other than active medical device.
6. Invasive Medical Devices: Medical devices that enter the body wholly/partly through an opening/surface of the body.
7. Non-invasive medical devices: Medical devices that do not penetrate the body fully/partly through body openings/body surfaces.
Medical device classification: Medical devices are classified according to the risks arising from the use of these medical devices. Based on these risks, medical devices are divided into the following four categories
1. Class A: low risk, such as: surgical equipment, surgical gloves, oxygen masks, etc.
2. Class B: Low to moderate risk, eg: cuffs, steam sterilizers, etc.
3. Class C: Moderate to high risk, such as: height monitors, X-ray machines, etc.
4. Class D: high risk, such as: high risk cardiac stents, pacemakers, etc.
Classification of in-vitro diagnostic medical devices: The classification of risk levels is influenced by individual risk factors and public health risks, and is divided into the following four categories
1. Class A: Low personal risk and low public health risk, such as: clinical chemistry analyzers, cholesterol tests, uric acid tests, etc.
2. Class B: Moderate personal risk and low public health risk, such as pregnancy test sticks, etc.
3. Class C: High personal risk and moderate public health risk, such as self-use blood glucose testing kits, HLA typing, PSA screening, etc.
4. Class D: High personal risk and high public health risk, eg: HIV screening of blood donors, HIV blood diagnosis, etc.
【參考連結】
http://regalkes.kemkes.go.id/informasi_alkes/Pedoman%20Klasifikasi.pdf
HLF-ID-20
If a foreign company wants to sell medical devices in Indonesia, no matter if it sets up a 100% subsidiary or branch, does it need to obtain an approval from local health bureau before the company’s registration?
If so, what are the requests? What are the required documents and application procedures? Website?
Evershine RD：
需要，須以印尼當地公司名義取得醫療器材經銷許可證(DAK)。
It needs to be in the name of a local Indonesian company and obtain a medical device distribution license (DAK).
The Medical Device Distributor License is issued by the Ministry of Health, and the distribution/delivery of medical devices can take place throughout Indonesia from the location where the Medical Device Distributor is located.
Medical Device Distributors and Branch Distributors can distribute medical devices according to the facilities and human resources they have, according to approved product groups, which are divided into 5 groups:
1. Radiation electronic medical device
2. Non-radiating electronic medical devices
3. Sterile non-electronic medical devices
4. Non-sterile electronic medical devices
5. In vitro diagnostic medical device
Medical device distributors must meet the following requirements:
1. Business actors are non-individual business actors in the form of limited liability companies or cooperatives
2. Proof of payment of non-tax state income (PNBP)
3. Technical staff information
4. The duration of the implementation of the criteria by business participants is 1 year after the OSS application is approved
5. The technical person in charge has CDAKB training certificate
6. Business Operations Plan
7. List of Product Types Distributed
8. Product manual
9. Owned HR data
10. Own storage facilities
． Building layout and photos
． List of warehouse equipment
11. Technicians who own or cooperate with distributors or manufacturers who hold a license to distribute electronic medical devices and/or in vitro diagnostic instruments.
Special requirements for medical device distribution branches
1. Technical leaders have CDAKB training certificate
2. Business operation plan
3. List of product types to be distributed
4. Product manuals, HR data owned
5. Own storage facilities
6. Layout and photos of the building
7. Established procedures in accordance with government regulations to support business activities
8. Warehouse Equipment List
9. Technicians owned by themselves or in cooperation with their central distributor for medical and/or electro-medical device
Notice
1. Facilities of medical device distribution and branch offices must have buildings and facilities that meet product requirements, whose office, warehouse, and/or workshop addresses cannot be virtual addresses, and must be compliant.
2. Medical device dealers or branches must have an organizational structure that meets operational needs, equipped with a company structure chart, and clearly explain the responsibilities and authorities of each person.
There must be 1 technician who is Indonesian nationality, and has the ability and ability to be accepted. Authorized, responsible, make the distribution system work well, ensure the safety and quality of medical device, have a minimum educational background according to the following table.
Radiation electronic medical device
． DIII/S1: Pharmacist/Pharmacist
． DIII/DIV: Electromedicine
． S1: Electrical Engineering
． DIII/DIV Engineering: Diagnostic Radiology and Radiation Therapy
． S1: Biomedical Engineering
． S1: Medical Physics
Non-radiating electronic medical device
． DIII/S1: Pharmacist/Pharmacist
． DIII/DIV: Electromedicine
． S1: Electrical Engineering
． DIII/DIV Engineering: Diagnostic Radiology and Radiation Therapy
． S1: Biomedical Engineering
． DIII/S1 Informatics Engineering (specifically for medical device software)
． DIII refractive optics (especially eye care devices)
． DIII Dental Engineering (specialized for dental equipment)
Sterile Non-Electronic Medical Devices
． DIII/S1: Pharmacist/Pharmacist
General medical device
． PJT Education
3. The technical leader shall not be a director/commissioner, if the company has other production or distribution facilities, there must be a different technical leader.
4. The person in charge of technology must be trained on the Good Circulation of Medical device (CDAKB), and have a CDAKB training certificate to prove it.
5. The technical person in charge needs to be a full-time worker. If the technical person in charge is temporarily unable to perform his duties (such as sick leave, maternity leave, etc.), the dealers and branches must appoint a temporary substitute for the technical person in charge with background.
6. There must be a cooperation agreement between the company and the technical director, which must be certified by a notary public.
7. If a dealer or a dealer’s branch has more than 1 warehouse location, there must be an educated warehouse manager at each location.
8. There must be a training program in place to improve the human resource’s ability to manage medical device.
9. Persons handling medical device are at high risk and/or may cause adverse effects, such as infections and allergies, requiring special training.
10. Must have a competent and experienced technician capable of installing, maintaining and repairing distributed medical devices with a minimum SMK education and full-time working hours in electrical engineering, mechanics or automotive
【參考連結】
http://regalkes.kemkes.go.id/informasi_alkes/PERMENKES%20No%201191%20Tahun%202010%20Tentang%20Penyalur%20Alat%20Kesehatan.pdf
http://regalkes.kemkes.go.id/#home/Informasi/informasiAlkes
HLF-ID-25
假如需要辦理，請問印尼有專業服務公司可以協助辦理醫療器材公司營業許可證？
Evershine RD：
Andaman
ST
HLF-ID-30
If a foreign company wants to sell medical devices in Indonesia, can it assign a Indonesia company to act as a business agent?
What are the requests for acting as a business agent? What are the required documents and application procedures?
What is the product liability of foreign companies and the business agents? Website?
Evershine RD：
It needs to be in the name of a local Indonesian company and obtain a medical device distribution license (DAK).
The Medical Device Distributor License is issued by the Ministry of Health, and the distribution/delivery of medical devices can take place throughout Indonesia from the location where the Medical Device Distributor is located. Medical Device Distributors and Branch Distributors can distribute medical devices according to the facilities and human resources they have, according to approved product groups, which are divided into 5 groups:
1. Radiation electronic medical device
2. Non-radiating electronic medical devices
3. Sterile non-electronic medical devices
4. Non-sterile electronic medical devices
5. In vitro diagnostic medical device
Medical device distributors must meet the following requirements:
1. Business actors are non-individual business actors in the form of limited liability companies or cooperatives
2. Proof of payment of non-tax state income (PNBP)
3. Technical staff information
4. The duration of the implementation of the criteria by business participants is 1 year after the OSS application is approved
5. The technical person in charge has CDAKB training certificate
6. Business Operations Plan
7. List of Product Types Distributed
8. Product manual
9. Owned HR data
10. Own storage facilities
． Building layout and photos
． List of warehouse equipment
11. Technicians who own or cooperate with distributors or manufacturers who hold a license to distribute electronic medical devices and/or in vitro diagnostic instruments.
Special requirements for medical device distribution branches
1. Technical leaders have CDAKB training certificate
2. Business operation plan
3. List of product types to be distributed
4. Product manuals, HR data owned
5. Own storage facilities
6. Layout and photos of the building
7. Established procedures in accordance with government regulations to support business activities
8. Warehouse Equipment List
9. Technicians owned by themselves or in cooperation with their central distributor for medical and/or electro-medical device
Notice
1. Facilities of medical device distribution and branch offices must have buildings and facilities that meet product requirements, whose office, warehouse, and/or workshop addresses cannot be virtual addresses, and must be compliant.
2. Medical device dealers or branches must have an organizational structure that meets operational needs, equipped with a company structure chart, and clearly explain the responsibilities and authorities of each person. There must be 1 technician who is Indonesian nationality, and has the ability and ability to be accepted. Authorized, responsible, make the distribution system work well, ensure the safety and quality of medical device, have a minimum educational background according to the following table.
Radiation electronic medical device
． DIII/S1: Pharmacist/Pharmacist
． DIII/DIV: Electromedicine
． S1: Electrical Engineering
． DIII/DIV Engineering: Diagnostic Radiology and Radiation Therapy
． S1: Biomedical Engineering
． S1: Medical Physics
Non-radiating electronic medical device
． DIII/S1: Pharmacist/Pharmacist
． DIII/DIV: Electromedicine
． S1: Electrical Engineering
． DIII/DIV Engineering: Diagnostic Radiology and Radiation Therapy
． S1: Biomedical Engineering
． DIII/S1 Informatics Engineering (specifically for medical device software)
． DIII refractive optics (especially eye care devices)
． DIII Dental Engineering (specialized for dental equipment)
Sterile Non-Electronic Medical Devices
． DIII/S1: Pharmacist/Pharmacist
General medical device
． PJT Education
3. The technical leader shall not be a director/commissioner, if the company has other production or distribution facilities, there must be a different technical leader.
4. The person in charge of technology must be trained on the Good Circulation of Medical device (CDAKB), and have a CDAKB training certificate to prove it.
5. The technical person in charge needs to be a full-time worker. If the technical person in charge is temporarily unable to perform his duties (such as sick leave, maternity leave, etc.), the dealers and branches must appoint a temporary substitute for the technical person in charge with background.
6. There must be a cooperation agreement between the company and the technical director, which must be certified by a notary public.
7. If a dealer or a dealer’s branch has more than 1 warehouse location, there must be an educated warehouse manager at each location.
8. There must be a training program in place to improve the human resource’s ability to manage medical device.
9. Persons handling medical device are at high risk and/or may cause adverse effects, such as infections and allergies, requiring special training.
10. Must have a competent and experienced technician capable of installing, maintaining and repairing distributed medical devices with a minimum SMK education and full-time working hours in electrical engineering, mechanics or automotive
The application process
1. The applicant must submit a written application to the Department of Health.
URL: http://regalkes.kemkes.go.id/#home/Informasi/informasiAlkes
2. Within 12 working days after receiving the copy of the application, the person in charge will cooperate with the person in charge of the district/city health office to form a joint inspection team to conduct local inspections.
3. If the requirements are met, the results of the inspection by the Joint Inspection Unit shall be forwarded to the Director General within 6 working days of receipt.
Responsibility
1. The product license holder must be responsible for any product liability for the sale of medical devices, in vitro diagnostic medical devices.
2. Any medical device and in vitro diagnostic medical device produced by OEM are not only responsible for the product license holder, but also the product owner.
3. Any entrusted production of medical device and in vitro diagnostic medical device is not only the responsibility of the product license holder, but also the responsibility of the entrusted manufacturer.
【參考連結】
http://regalkes.kemkes.go.id/#home/Informasi/informasiAlkes
HLF-ID-35
假如需要辦理指派印尼公司擔任營業代理人，請問印尼有專業服務公司可以協助？
Evershine RD：
Total Sinergi
Multipard Mandiri
HLF-ID-40
Do foreign companies need to apply for an approval before importing medical devices sold to Indonesia?
If yes, which authority is in charge? What documents are required? What is the application process?
Do medical devices packaging and labeling require prior approval? Which languages are allowed? Website?
Evershine RD：
Yes, only a local company in Indonesia can register the medical device.
Any medical device, in vitro diagnostic medical device produced, imported, assembled and/or repackaged for distribution in Indonesia must have a product license, and the applicant must be a locally legally established corporate entity or commercial entity importing medical devices, in vitro diagnostic Applicants for product licenses for medical devices:
1. Sole Agent/Exclusive Distributor/Exclusive Distributor.
2. Distributors (PAK), Importers (PKRT): Have the written appointment of the manufacturer or the principal, and are authorized to register medical devices, in vitro diagnostic medical devices in Indonesia.
3. Distributor (PAK), Importer (PKRT): As the product owner who has a written agreement with the manufacturer.
4. Distributors (PAKs) for assembly, repackaging.
To apply for a product license you must have:
1. Comply with Good Manufacturing Practice.
2. Safety and efficacy proven by clinical evaluation report and/or any other evidence.
3. The dosage should not exceed the content limit of the current standards, requirements and regulations.
4. Do not use any prohibited materials according to current standards, requirements and regulations.
5. Must be accompanied by a Certificate of Free Sale (CFS) issued by the health authority of the country of origin, if not registered in the country of origin, the CFS can be issued by any other agency in the country of origin. Evidence needs to show:
．Product Name/Brand Name
．Type of product
．Manufacturer’s name and address
．Validity period
The application process
1. Submit application materials on the Electronic System webpage of the General Directorate of Pharmacies and Medical device (Regalkes).
URL: http://regalkes.kemkes.go.id/
2. Required documents for application
Administrative Request
．Production Certificate/PAK License
．Power of Attorney as Sole Agent/Sole Distributor/Sole Distributor
．Certificate of Free Sale (CFS) issued by the relevant agency (imported products)
．Quality Management System Documentation (ISO 13485, ISO 9001, CE, etc.)
．Trademark certificate (if any)
Technical requirements
．Product Information: Materials, Formulations, Device Information, Descriptions and Characteristics, Standards and Manufacturing Processes, Indications, Intended Uses and Instructions for Use, Contraindications, Warnings, Cautions, Potential Adverse Effects.
．Specifications and Quality Assurance: Raw Material Specifications and Material Safety Data Sheets (MSDS)
．Packaging Specifications
．Equipment Performance Specifications
．Laboratory Test Results: Certificate of Analysis (CoA), Stability Test, Sterility Test, Electrical Safety Test
．Preclinical, clinical research results (for Class C, D medical devices and in vitro diagnostic medical devices)
．Risk Management
special requirements
． Radiation Material Safety
． Clinical Trials of HIV Products in National Reference Laboratories
Labeling Requirements
． Label samples and descriptions
． Instructions for use, material installation and maintenance instructions
post-marketing requirements
． Adverse Events and Complaints Recording and Management Procedures
3. The applicant shall be responsible for the completeness, authenticity and validity of any application documents uploaded by the electronic system. Experts will evaluate and verify the administrative and technical requirements of each application for medical device product license and in vitro diagnostic medical device. The implementation period is as follows:
． Class A within 15 days.
． Class B within 30 days.
． Class C within 30 days.
． Class D within 45 days.
4. The product license is issued in electronic form and printed by itself. In case of force majeure, it can be issued in paper.
5. PKRT as non-tax state income needs to be paid electronically.
6. Product licenses are valid for a maximum of 5 years.
7. If a product license application is submitted by a PAK or PKRT company designated as Sole Agent/Exclusive Distributor/Sole Distributor and/or Authorized Registration, the Product License will be valid for the duration of that appointment or authorization for at least 2 years, up to 5 years.
8. If the medical device, in vitro diagnostic medical device is produced by the manufacturer through OEM, the validity period of its product license shall not exceed 3 years.
9. The validity period of the product license can be renewed if any requirements are met.
Packaging and Labeling
Medical device and in vitro diagnostic medical device labels and information must state the conditions for safety, efficacy/performance, instructions for use and/or any other information. required materials:
1. Product name/brand name
2. Product License Number
3. Product Type
4. Manufacturer/manufacturer’s name and address
5. Name and address of PKRT importer
6. Lot Number/Production Code/Serial Number
7. The term sterile and how sterile products are sterilized (if applicable)
8. Product Specifications
9. Purpose of use and instructions for use
10. Validity Period (if applicable)
11. List of active materials used and their percentages
12. Net weight or net content
13. Production code
14. Instructions for use/preparation
15. Cautions and Warnings
16. Warning labels for certain medical devices and in vitro diagnostic medical devices, such as professional use only or the letter symbol P, in white font on a black background, must be used by qualified personnel.
17. If a statement of the net content of the active substance, ingredients and amounts, contraindications, caution and warning labels or KTD/side effects are included, the label and information must state the same.
18. The above content must be presented in Indonesian. Languages other than Indonesian are allowed if there is no corresponding word or it cannot be created or used for overseas trade.
19. The following words are prohibited in the labels and information of medical devices and in vitro diagnostic medical devices:
． Superlative words such as most, very, first, only, top, effective, super, excellent, amazing, amazing, perfect, or words with the -est (most) suffix, and/or the same that explains this superiority meaning of words.
． Such as sterile, mosquito-free, safe, eradication, aromatherapy, anti-aging, therapeutic, dengue prevention, anti-viral, relaxing, doctor recommended and/or any other synonym.
． Write percentages or other claims to demonstrate the effectiveness of the product.
． Use of family, child, baby, softening, moisturizing and/or any other words with the same meaning in any household pesticide product.
Halal certification process
1. The product license holder shall apply in writing to BPJPH for halal certification. BPJPH must confirm the completeness of the application documents within 1 business day after submission.
2. Upon application, designate LPH to inspect and/or test the halal status of the product.
3. LPH appoints halal auditors to conduct halal inspections of products. Conduct product halal inspections on business premises during production. During the product inspection process, if any ingredients are suspected of being halal, they should be tested in the laboratory.
4. The halal auditor submits the product halal inspection result to LPH. LPH submits results to MUI and sends a copy to BPJPH.
5. The determination of product halal level is carried out by MUI and in Halal Fatwa Assembly. The Halal Product Recognition Decree (Halal Fatwa) is submitted by MUI to BPJPH as the basis for issuing Halal certificates.
6. BPJPH shall issue a halal certificate within 1 working day if the halal decree meeting determines that the product applied by the operator is halal. If the Halal Decree Assembly determines that the product is not Halal, BPJPH will return the Halal certificate application with the reason within 1 working day.
7. The company must implement the Halal Assurance System (HAS) before applying and registering for the Halal certification process. The halal assurance system is based on the halal policy, establishes a halal management team, compiles a HAS manual, conducts training, compiles relevant HAS procedures, implements internal audits, and properly reviews management.
8. Certification documents
． Product List
． Bill of Materials and Material Documentation
． Butcher’s List (especially slaughterhouses)
． Product Matrix
． HAS Manual
． Flow chart
． Production Facility Address List
． Evidence of the spread of the halal policy
． Evidence of internal training and evidence of internal audit.
9. Register Halal Certificate (Upload Data)
10. Monitor the pre-audit and contract payments for the halal certification process
11. Perform an audit
12. Perform post-audit monitoring
13. Halal certificate is valid for 4 years
14. Applicants submitting a halal certificate must:
．Provide correct, clear and truthful information
．Separation of locations, premises and equipment between halal and non-halal products for processing, storage, packaging, distribution, sale and display
．Reporting changes in material composition to BPJPH
15. Operators who have obtained a Halal certificate must:
．Put a halal label on products with a halal certificate
．Maintain halal for products that have obtained a halal certificate
．Separate locations, premises and equipment for processing, storage, packaging, distribution, sale and display of halal and non-halal products
．If the validity period of the halal certificate has passed, the halal certificate must be renewed
．Report changes to material composition to BPJPH
16. Halal Label: Halal certified products must be marked on the outer packaging as Halal, or non-Halal information that is not Halal certified. Operators who have obtained a halal certificate must affix a halal label at the following locations:
．Product packaging
．Specific part of the product
．The exact location of the product
．Halal labels must be easy to see and read, and not easily erased, detached and damaged.
【參考連結】
http://regalkes.kemkes.go.id/informasi_alkes/Regulasi%20Lisensi%20Produk.pdf
HLF-ID-45
請問在印尼有哪些專業服務機構，可以協助辦理醫療器材產品許可證？
Evershine RD：
ARQon
Andaman
HLF-ID-50
Can a foreign company apply for a product license by its own name? If yes, which authority is in charge? What documents are required? What is the application process? Do medical devices packaging and labeling require prior approval? Which languages are allowed?Website?
Evershine RD：
Only a local company in Indonesia can register the medical device.
Any medical device, in vitro diagnostic medical device produced, imported, assembled and/or repackaged for distribution in Indonesia must have a product license, and the applicant must be a locally legally established corporate entity or commercial entity importing medical devices, in vitro diagnostic Applicants for product licenses for medical devices:
1. Sole Agent/Exclusive Distributor/Exclusive Distributor.
2. Distributors (PAK), Importers (PKRT): Have the written appointment of the manufacturer or the principal, and are authorized to register medical devices, in vitro diagnostic medical devices in Indonesia.
3. Distributor (PAK), Importer (PKRT): As the product owner who has a written agreement with the manufacturer.
4. Distributors (PAKs) for assembly, repackaging.
To apply for a product license you must have:
1. Comply with Good Manufacturing Practice.
2. Safety and efficacy proven by clinical evaluation report and/or any other evidence.
3. The dosage should not exceed the content limit of the current standards, requirements and regulations.
4. Do not use any prohibited materials according to current standards, requirements and regulations.
5. Must be accompanied by a Certificate of Free Sale (CFS) issued by the health authority of the country of origin, if not registered in the country of origin, the CFS can be issued by any other agency in the country of origin. Evidence needs to show:
．Product Name/Brand Name
．Type of product
．Manufacturer’s name and address
．Validity period
The application process
1. Submit application materials on the Electronic System webpage of the General Directorate of Pharmacies and Medical device (Regalkes).
URL: http://regalkes.kemkes.go.id/
2. Required documents for application
Administrative Request
．Production Certificate/PAK License
．Power of Attorney as Sole Agent/Sole Distributor/Sole Distributor
．Certificate of Free Sale (CFS) issued by the relevant agency (imported products)
．Quality Management System Documentation (ISO 13485, ISO 9001, CE, etc.)
．Trademark certificate (if any)
Technical requirements
．Product Information: Materials, Formulations, Device Information, Descriptions and Characteristics, Standards and Manufacturing Processes, Indications, Intended Uses and Instructions for Use, Contraindications, Warnings, Cautions, Potential Adverse Effects.
．Specifications and Quality Assurance: Raw Material Specifications and Material Safety Data Sheets (MSDS)
．Packaging Specifications
．Equipment Performance Specifications
．Laboratory Test Results: Certificate of Analysis (CoA), Stability Test, Sterility Test, Electrical Safety Test
．Preclinical, clinical research results (for Class C, D medical devices and in vitro diagnostic medical devices)
．Risk Management
special requirements
． Radiation Material Safety
． Clinical Trials of HIV Products in National Reference Laboratories
Labeling Requirements
． Label samples and descriptions
． Instructions for use, material installation and maintenance instructions
post-marketing requirements
． Adverse Events and Complaints Recording and Management Procedures
3. The applicant shall be responsible for the completeness, authenticity and validity of any application documents uploaded by the electronic system. Experts will evaluate and verify the administrative and technical requirements of each application for medical device product license and in vitro diagnostic medical device. The implementation period is as follows:
． Class A within 15 days.
． Class B within 30 days.
． Class C within 30 days.
． Class D within 45 days.
4. The product license is issued in electronic form and printed by itself. In case of force majeure, it can be issued in paper.
5. PKRT as non-tax state income needs to be paid electronically.
6. Product licenses are valid for a maximum of 5 years.
7. If a product license application is submitted by a PAK or PKRT company designated as Sole Agent/Exclusive Distributor/Sole Distributor and/or Authorized Registration, the Product License will be valid for the duration of that appointment or authorization for at least 2 years, up to 5 years.
8. If the medical device, in vitro diagnostic medical device is produced by the manufacturer through OEM, the validity period of its product license shall not exceed 3 years.
9. The validity period of the product license can be renewed if any requirements are met.
Packaging and Labeling
Medical device and in vitro diagnostic medical device labels and information must state the conditions for safety, efficacy/performance, instructions for use and/or any other information. required materials:
1. Product name/brand name
2. Product License Number
3. Product Type
4. Manufacturer/manufacturer’s name and address
5. Name and address of PKRT importer
6. Lot Number/Production Code/Serial Number
7. The term sterile and how sterile products are sterilized (if applicable)
8. Product Specifications
9. Purpose of use and instructions for use
10. Validity Period (if applicable)
11. List of active materials used and their percentages
12. Net weight or net content
13. Production code
14. Instructions for use/preparation
15. Cautions and Warnings
16. Warning labels for certain medical devices and in vitro diagnostic medical devices, such as professional use only or the letter symbol P, in white font on a black background, must be used by qualified personnel.
17. If a statement of the net content of the active substance, ingredients and amounts, contraindications, caution and warning labels or KTD/side effects are included, the label and information must state the same.
18. The above content must be presented in Indonesian. Languages other than Indonesian are allowed if there is no corresponding word or it cannot be created or used for overseas trade.
19. The following words are prohibited in the labels and information of medical devices and in vitro diagnostic medical devices:
． Superlative words such as most, very, first, only, top, effective, super, excellent, amazing, amazing, perfect, or words with the -est (most) suffix, and/or the same that explains this superiority meaning of words.
． Such as sterile, mosquito-free, safe, eradication, aromatherapy, anti-aging, therapeutic, dengue prevention, anti-viral, relaxing, doctor recommended and/or any other synonym.
． Write percentages or other claims to demonstrate the effectiveness of the product.
． Use of family, child, baby, softening, moisturizing and/or any other words with the same meaning in any household pesticide product.
Halal certification process
1. The product license holder shall apply in writing to BPJPH for halal certification. BPJPH must confirm the completeness of the application documents within 1 business day after submission.
2. Upon application, designate LPH to inspect and/or test the halal status of the product.
3. LPH appoints halal auditors to conduct halal inspections of products.
Conduct product halal inspections on business premises during production. During the product inspection process, if any ingredients are suspected of being halal, they should be tested in the laboratory.
4. The halal auditor submits the product halal inspection result to LPH. LPH submits results to MUI and sends a copy to BPJPH.
5. The determination of product halal level is carried out by MUI and in Halal Fatwa Assembly. The Halal Product Recognition Decree (Halal Fatwa) is submitted by MUI to BPJPH as the basis for issuing Halal certificates.
6. BPJPH shall issue a halal certificate within 1 working day if the halal decree meeting determines that the product applied by the operator is halal. If the Halal Decree Assembly determines that the product is not Halal, BPJPH will return the Halal certificate application with the reason within 1 working day.
7. The company must implement the Halal Assurance System (HAS) before applying and registering for the Halal certification process. The halal assurance system is based on the halal policy, establishes a halal management team, compiles a HAS manual, conducts training, compiles relevant HAS procedures, implements internal audits, and properly reviews management.
8. Certification documents
． Product List
． Bill of Materials and Material Documentation
． Butcher’s List (especially slaughterhouses)
． Product Matrix
． HAS Manual
． Flow chart
． Production Facility Address List
． Evidence of the spread of the halal policy
． Evidence of internal training and evidence of internal audit.
9. Register Halal Certificate (Upload Data)
10. Monitor the pre-audit and contract payments for the halal certification process
11. Perform an audit
12. Perform post-audit monitoring
13. Halal certificate is valid for 4 years
14. Applicants submitting a halal certificate must:
．Provide correct, clear and truthful information
．Separation of locations, premises and equipment between halal and non-halal products for processing, storage, packaging, distribution, sale and display
．Reporting changes in material composition to BPJPH
15. Operators who have obtained a Halal certificate must:
．Put a halal label on products with a halal certificate
．Maintain halal for products that have obtained a halal certificate
．Separate locations, premises and equipment for processing, storage, packaging, distribution, sale and display of halal and non-halal products
．If the validity period of the halal certificate has passed, the halal certificate must be renewed
．Report changes to material composition to BPJPH
16. Halal Label: Halal certified products must be marked on the outer packaging as Halal, or non-Halal information that is not Halal certified. Operators who have obtained a halal certificate must affix a halal label at the following locations:
．Product packaging
．Specific part of the product
．The exact location of the product
．Halal labels must be easy to see and read, and not easily erased, detached and damaged.
【參考連結】
http://regalkes.kemkes.go.id/informasi_alkes/Regulasi%20Lisensi%20Produk.pdf
HLF-ID-55
請問在印尼有哪些專業服務機構，可以協助以外國公司名義辦理醫療器材產品許可證？
ARQon
Qualtechs
https://www.qualtechs.com/en-gb/
HLF-ID-60
What documents are required when importing approved medical devices into Indonesia? What is the procedure? Any preparation is required to submit to the Ministry of Health and Welfare for selling products? Website?
Evershine RD：
Customs procedures
1. Register at the General Administration of Customs and obtain a Customs Registration Number (NIK)
URL: https://customer.beacukai.go.id/index.html?page=registrasi
2. Obtain the import license, which is valid for 5 years, and can be renewed thereafter.
3. Import licenses can be managed through Electronic Data Interconnection (EDI) and are classified into two categories:
． General Importer Registration Number (API-U): for general trade
． Production Importer Registration Number (API-P): For importers of goods for their own use, such as raw materials, auxiliary materials and/or other products used to support the production process
4. Complete the import declaration form and submit it to the General Administration of Customs, which includes:
． Invoice
． Packaging List
． B/L
． Insurance policy
． Import duty
． Relevant tax receipts, etc.
5. After obtaining the importer and exporter code and import license, the importer should determine and declare the source or origin of the imported goods and follow the customs clearance procedures.
6. Calculation of import duty rates (importers who import any imported goods should assess their own duties on such goods)
7. Information required
．Name, full business address
．Conditions and description of the premises where the notified goods are kept or stored
．Details of the goods
．The date and the name and full address of the person who received such shipment
．The name of the owner of the goods
．The name of the goods
．The location of the place where the goods are taken out
．Notify the location of the goods being shipped to the premises
．Means of transportation (If a motor vehicle is used to transport the notified goods, the registration number of the motor vehicle is required.)
．Shipping route, time and date of start of shipment, possible time and date of arrival at destination
．The name and full business address of the person who sold or transferred the notified goods
．Name and full address of the person to whom the notified goods are sold or transferred
．Time and date of sale or assignment
．Quantity of goods, market price
．Serial number (if available)
．Lot number (if available)
．Patent number (if applicable)
．Manufacturer, country of origin (if applicable)
．Brand (if available)
．Trademark (if applicable)
8. The cargo shall not be unloaded from the vessel before it is allowed to enter the country
9. Only unload and load goods at approved locations
10. The importer shall make and sign a declaration on the authenticity of the contents of the entry document when presenting the entry document, and shall, in support of the declaration, present to the relevant officials the invoice (if any) and other provisions related to the imported goods as may be stipulated. document
11. The importer of the entry note shall ensure the following
．Accuracy and completeness of information provided
．The authenticity and validity of any documents that support it
．Comply with any restrictions or prohibitions on the Goods under this Act or any other law then in force
【參考連結】
https://www.beacukai.go.id/index.html
HLF-ID-70
What are the laboratory inspection materials that need to be attached for verification? Website?
Evershine RD：
In Indonesia, in order to obtain product licenses for medical devices, manufacturers must comply with GMP, and must have quality management system documents (ISO 13485, ISO 9001, CE, etc.) to prove that they must submit relevant documents:
Administrative Request
．Production Certificate/PAK License
．Power of Attorney as Sole Agent/Sole Distributor/Sole Distributor
．Certificate of Free Sale (CFS) issued by the relevant agency (imported products)
．Quality Management System Documentation (ISO 13485, ISO 9001, CE, etc.)
．Trademark certificate (if any)
Technical requirements
．Product Information: Materials, Formulations, Device Information, Descriptions and Characteristics, Standards and Manufacturing Processes, Indications, Intended Uses and Instructions for Use, Contraindications, Warnings, Cautions, Potential Adverse Effects.
．Specifications and Quality Assurance: Raw Material Specifications and Material Safety Data Sheets (MSDS)
．Packaging Specifications
．Equipment Performance Specifications
．Laboratory Test Results: Certificate of Analysis (CoA), Stability Test, Sterility Test, Electrical Safety Test
．Preclinical, clinical research results (for Class C, D medical devices and in vitro diagnostic medical devices)
．Risk Management
Special requirements
． Radiation Material Safety
． Clinical Trials of HIV Products in National Reference Laboratories
Labeling Requirements
． Label samples and descriptions
． Instructions for use, material installation and maintenance instructions
post-marketing requirements
． Adverse Events and Complaints Recording and Management Procedures
【參考連結】
http://regalkes.kemkes.go.id/informasi_alkes/Regulasi%20Lisensi%20Produk.pdf
HLF-ID-75
印尼醫療器材審核機構，能夠接受海外檢驗機構的檢驗資料嗎？假如是的話，有些被認可的機構？網頁？
Evershine RD：
CMS
Nemko
https://www.nemko.com/?hsLang=en
HLF-ID-77
請問在印尼有哪些醫療器材檢驗機構可以提供醫療器材檢驗服務？網頁？
Evershine RD：
TÜV
Emerhub
Credevo
HLF-ID-80
After a foreign subsidiary imports medical devices and entrusts a distributor in Indonesia to sell it, does the distributor need a medical devices business license?
What are the respective responsibilities of foreign subsidiaries and distributors if cosmetic products have quality defects? Is it joint liability? Or can the responsibility of the foreign subsidiary be regulated?
Evershine RD：
It needs to be in the name of a local Indonesian company and obtain a medical device distribution license (DAK).
Responsibility
1. The product license holder must be responsible for any product liability for the sale of medical devices, in vitro diagnostic medical devices.
2. Any medical device and in vitro diagnostic medical device produced by OEM are not only responsible for the product license holder, but also the product owner.
3. Any entrusted production of medical device and in vitro diagnostic medical device is not only the responsibility of the product license holder, but also the responsibility of the entrusted manufacturer.
【參考連結】
http://regalkes.kemkes.go.id/#home/Informasi/informasiAlkes
HLF-ID-85
請問在印尼有哪些專精於醫療器材銷售與消費權益相關法律服務的業者？
Evershine RD：
Hadromi & Partners
Schinder
DHP Lawyers
*Labor Law Regulation compliance audit.
*Evershine use online payroll relevant 5-in-1 System support our services:
-GPS-Clocking ; Staff Scheduling;
-Leave system ; Overtime System;
-Payroll Parameter Collection System;
-payroll gross to net calculation
*Pay salary through internet Banking Function
We act as your in-house accountant supported by cloud accounting and payroll system.
We are a member of LEA and IAPA.
Our affiliated companies are located at major cities in Eastern China area.
We are featured in providing services to the overseas entities of MNC (Multi-National-Companies) parent companies.
Read more
Company registration,
Work Permit and Visa application;
Online Accounting Services,
Payment Services,
Tax Compliance Services;
Payroll compliance Services,
Trademark Registration;
Due Diligence for M&A project.
Read more
*International Tax Planning
*Company Registration
*Work Permit Application
*Import and Export Permit and License Application
*Food and Drink Business Permit and License Application
*Medical Devise Business Permit and License Application
Read more