REGULATION OF THE MINISTER OF HEALTH CONCERNING THE SAFEGUARDING OF MEDICAL DEVICES AND HOUSEHOLD HEALTH SUPPLIES
As used in this government regulation:
(1) Medical Device Product and Household Health Supplies in circulation must fulfil the quality, usefulness and safety requirements.
(2) Quality, usefulness and safety requirements as meant in paragraph (1) are conform to the Indonesian Pharmacopoeia , National Standards of Indonesia (SNI) and Guidelines for Assessment of Medical Devices and Household Health Supplies (PKRT), and other standards as stipulated by the Minister.
(1) Production of Medical Devices and or Household Health Supplies can only be conducted by a Company that holds production certificate issued by the Minister.
(2) The Minister delegates the authority of production certificate granting to the Director General.
(3) Home company producing certain Medical Devices and or Household Health Supply products is not required to follow provisions in paragraph (1).
(4) Provisions on paragraph (3) is stipulated by the Director General.
(1) Company producing Medical Devices and or Household Health Supplies that obtains a production certificate must be able to show that the production has been carried out in accordance with Guidelines for Proper Manufacturing Method of Medical Devices and or Household Health Supplies.
(2) The Guidelines for Proper Manufacturing Method of Medical Devices and Household Health Supplies and Household Health Supplies as contemplated in paragraph (1) is stipulated by the Minister.
The Company must be able to guarantee that its product is neither:
(1) The company applying for a production certificate must be incorporated as Legal Entity or Business Entity.
(2) The company applying for a production certificate must meet the administrative and technical requirements.
(1) Company producing Medical Devices and or Household Health Supplies must have a person in charge of technique who is work fulltime in accordance with the product to be produced.
(2) The Person in Charge of Technique shall has education of (Pharmacist, Other Bachelor Graduates who are relevant or having certificate, and ATEM for Electromedic Health Devices) for Class A. Graduated at least D3 (Chemical Pharmacy, Engineering that is relevant to their scope of duty) for Class B. For Class C, they shall be graduated as Assistant Pharmacist or Other Personnel who is equivalent in accordance with his scope of duty.
The company applying for a production certificate must be ready and available to be examined for its readiness by the appointed personnel.
The Medical Device and or Household Health Supply production unit must be on a location that conforms to its designation to allow the prevention of the contamination and pollution to the product from the environment and the reverse.
(1) Buildings that are used to produce Medical Devices and or Household Health Supplies must comply with the technical and hygiene requirements, according to the product to be manufactured.
(2) Buildings as meant in paragraph (1) must have adequate and well-maintained sanitation facilities.
Parts of the building or production room of Medical Devices and or Household Health Supplies shall not be used for other purposes.
The Medical Devices and or Household Health Supplies must be produced by using tools of required quality.
The tools used to produce Medical Devices and or Household Health Supplies must be fitted with the type of product and shall always be in maintained condition.
The tools as meant in Article 12 shall only be used for purpose of production of Medical Devices and or Household Health Supplies.
(1) Materials to be used in producing Medical Devices and or Household Health Supplies must fulfil the quality, usefulness and safety standards.
(2) Medical Devices that use radioactive matters or able to emit radiation ray are regulated in accordance with provisions in the Government Regulation No. 12/1975 on Permits of Radioactive Matter Usage.
The Minister determines the types and concentrations of certain materials that are allowable in the production of Medical Devices and or Household Health Supplies.
Production of Medical Devices and or Household Health Supplies must be conducted in accordance with the Guidelines of Proper Manufacturing Method.
The Company producing Medical Devices and or Household Health Supplies must be able to conduct analysis and inspection of the production materials used, and end products.
In order to conduct to conduct analysis and inspection as meant in article 18, the producing company must have its own laboratory or cooperate with a recognized laboratory.
Employees who contact directly with the production of Medical Devices and or Household Health Supplies must be in healthy and clean condition.
Employee who have contagious diseases or certain diseases are prohibited to work in the Production of Medical Devices and Household Health Supplies.
In order to maintain the Occupational safety and health and to prevent cross-contamination from occurring, employees are obliged to wear work protection in accordance with the prevailing provisions.
(1) Production certificates are classified into 3 (three) classes, namely A, B and C;
(2) Certificate Class A is given to factory that is able to produce Medical Devices / PKRT of Classes I, II and III and has applied the Guidelines for Manufacturing Method of Medical Devices / PKRT in a whole. Certificate Class B is given to factory that is able to produce Medical Devices / PKRT of Class I and Class II and has applied the Guidelines for Proper Manufacturing Method of Medical Devices / PKRT in term of facilities, production process, documentation, sanitary hygiene and quality control. Certificate Class C is given to factory that is able to produce certain Medical Devices / PKRT of Class I and Class II and has applied the Guidelines for Proper Manufacturing Method in term of facilities, documentation, sanitary hygiene.
(1) To obtain a Production Certificate of Medical Devices and or Household Health Supplies, the Applicant Company must submit written application to the Minister via the Head of Local Provincial Health Service, by using example form as specified in attachments 1.1 - 1.14.
(2) The Head of Provincial Health Service, not later than 12 (twelve) working days after receiving carbon copy from the applicant, coordinates with the Head of Regencial/Municipal Health Service to establish Joint Inspection Team to carry out on-site inspection.
(3) The Joint Inspection Team shall, not later than 12 (twelve) working days, carry out inspection by using example form of Minutes of Examination as specified in attachment 2.1.
(4) In the event of compliance, the Head of Provincial Health Service shall, not later than 6 (six) working days as of its receipt of inspection results from the Joint Inspection Team, pass it to the Director General, by using example form as specified in attachment 3.
(5) In case the inspection as meant in paragraphs (2) through (4) is not carried out on time the relevant applicant Company can make statement letter of readiness to carry out activity to the Director General with carbon copy to the Head of Provincial Health Service and the Head of local Regencial/Municipal Health Service by using example form as specified in attachment 4.
(6) Within 12 (twelve) working days as meant in paragraph (5) the Director General may take action as it deems necessary in the framework of deferment or refusal of application letter for Production Certificate by using example form as specified in attachment 5 or 6.
(7) Within 12 (twelve) working days as of the receipt of report of inspection results as meant in paragraph (4), the Director General shall issue the Production Certificate of Medical Devices and or Household Health Supplies by using example form as specified in attachment 7.
(8) As to the deferment as meant in paragraph (6), an opportunity is given to complete the unmet requirements not later than 6 (six) month as of the issuance of the letter of deferment.
The Production Certificate shall be valid for 4 (four) years as of the issuance date.
(1) The Company that will continue its business shall apply for renewal of Production Certificate 3 (three) months prior to the expiry of the Production Certificate to the Director General via the Provincial Health Service;
(2) Procedures of renewal of Production Certificate prevail in accordance with the provisions as meant in article 24.
(1) Renewal of the Production Certificate other than as meant in article 26 can be conducted, in the event of:
(2) Application as meant in paragraph (1) shall be submitted by the applicant Company in writing to the Minister via the Head of Health Service in the relevant Province.
(3) Renewal of Production Certificate as contemplated in paragraph (1), unless any physical change in the facility building, need no on-site inspection.
(1) The producing Company must report its production results at least once every 1 (one) year to the Director General with carbon copy to the Head of Provincial Health Service and the Head of Regencial/Municipal Health Service according to its location by using form as attached in attachment 8.
(2) The Company holding circulation license of Medical Devices and or Household Health Supplies is obliged to submit periodic report at least once every 1 (one) year, unless stated otherwise, by using form as attached in attachment 9.
(1) Medical Devices and or Household Health Supplies to be circulated or for sale in the Indonesia territory, must obtain circulation license from the Minister.
(2) The Minister delegates the authority of circulation license granting to the Director General.
(3) Certain Medical Device and Household Health Supply Products that are produced by home industry are not required to obey the provisions in paragraph (2).
(4) Provisions on paragraph (8) are stipulated by the Director General.
(1) For purpose of assessing the quality, usefulness and safety of Medical Devices / PKRT in the framework of granting the circulation license, an Assessor Team and Expert Team of Medical Devices and PKRT are established.
(2) The Assessor Team and Expert Team as contemplated in paragraph (1) is stipulated by the Director General.
(3) The Expert Team as meant in paragraph (1) consists of the experts and Professional organizations, relevant Associations, Universities, Practicers and related Agencies.
(1) The application for circulation license of domestic produced Medical Devices and or Household Health Supplies shall be conducted by:
(2) Application for circulation license of imported Medical Devices and or Household Health Supplies shall be conduced by the Distributor of Medical Devices and or Household Health Supplies who is authorized to register from the producer or company responsible for the product abroad.
Medical Devices and or Household Health Supplies that obtain circulation license must fulfil the following criteria:
The imported Medical Devices and or Household Health Supplies must be traceable on its origin and the product responsible party abroad.
Application for circulation license of Medical Devices and or Household Health Supplies shall be submitted to the Director General by completing the form as specified in attachments 10.1 - 10.5 and or 11.1 - 11.5 and or 12.1 - 12.5 and or 13.1 - 13.5.
(1) Based on its safety, the Medical Device and or Household Health Supply products are divided into 3 (three) classes I, II, II.
(2) Classes of Medical Device and or Household Health Supply Products as contemplated in paragraph (1) are as specified in attachment 14.
Categorization and sub-categorization of Medical Devices and Household Health Supplies are as specified in attachment 15 and 15 A.
(1) In case any additional data is required for assessment, the Director General shall inform thereof in writing.
(2) The applicant Company is obliged to deliver the additional data as contemplated in paragraph (1) not later than 3 (three) months as of the notice date.
(3) In case the registration fails to meet the provisions as contemplated in paragraph (2), the Director General shall issues letter of refusal of registration.
(4) The application refused as meant in paragraph (3), can be resubmitted as a new registration if the requirements as meant in Article 31 and or additional data as meant in paragraph (1) are completed.
To the Medical Devices and or Household Health Supplies for which application has met the provisions as contemplated in Article 31, evaluation shall be conducted for its quality, usefulness, safety and marking.
Within not later than 3 (three) months as of the receipt of complete application for circulation license, the Director General shall notify its decision of either approval or refusal of registration.
(1) Circulation license Number is given to the Medical Device and or Household Health Supply that has been approved for its application for registration.
(2) The circulation license number must be specified on the marking or on the etiquette, container and wrapping of Medical Devices and or Household Health Supplies.
The circulation licence shall be valid for 4 (four) years as of the issuance date.
(1) The Director General can revoke approval of circulation license in the event:
(2) In the event of any dispute between the Company producing the Medical Device and or Household Health Supply and the agent holding the licence number, it shall be settled within 6 (six) months. If it is not settled yet, the Director General can revoke the circulation license.
(3) Revocation of approval as contemplated in paragraphs (1) and (2) shall be conducted with decision of revocation.
(1) In case the validity of circulation license of the Medical Device and or Household Health Supply expires, the Company is obliged to report it to the Director General for extension of circulation license.
(2) Extension of circulation license number for Medical Device and or Household Health Supply that is not changed, shall be conducted by evaluating the periodic report results against the side effects and results of quality monitoring of the Medical Devices and or Household Health Supplies.
(1) Certification on exported/imported Medical Devices and Household Health Supplies, if necessary, is given by the Director General.
(2) Certification as contemplated in paragraph (1) is issued by considering the quality, usefulness and safety of the Medical Devices and Household Health Supplies.
(1) The Medical Device Distributor is obliged to has the Medical Device Distributor Licence for from the Minister.
(2) The Minister delegates the authority pf distributor licence granting to the Director General.
(3) Pharmaceutical Wholesalers who will conduct business as Medical Device Distributor must meet the requirements as provided for in this regulation.
(1) Medical Device Distributor License is granted by the Director General.
(2) Medical Device Distributor Branch License is granted by the Head of Health Service.
(3) Medical Device Sub-Distributor License is granted by the Head of Provincial Health Service.
(4) Medical Device Store License is granted by the Head of Regencial/Municipal Health Service.
Application for Medical Device Distributor Licence can only be submitted by:
Renewal of Medical Device distributor business license must be conducted in the event any of the following occurs:
Medical Device Distributor is obliged to report its distribution results once every 1 (one) year to the Director General with carbon copy to the Head of local Provincial Health Service as specified in attachment 16.
Every change of person in charge of technique is obliged to be reported to not later than 6 (six) working days prior to the change, to the Director General with carbon copy to the Head of local Provincial Health Service.
Medical Device Distributor can establish branches throughout the territory of the Republic of Indonesia.
(1) Medical Device Distributor is obliged to has adequate facilities and infrastructures in order to be able to carry out processing, procurement, storage and distribution of Medical Devices and able to secure smooth implementation of tasks and functions of Medical Device distributor.
(2) Warehouses are obliged to be completed with equipments that are able to secure the safety of Medical Devices being stored in them.
(3) Medical Device Distributor is obliged to maintain record of procurement, storage and distribution orderly in their business site.
(4) Medical Device Distributor who distributes certain Medical Devices is obliged to provide or have after-sale guaranty in the forms of:
(1) The Medical Device Distributor is obliged to procure, store and distribute Medical Devices that meet safety requirement in accordance with the proper distribution method and the prevailing provisions.
(2) Guidelines for Proper Distribution Method of Medical Devices is stipulated by the Minister.
(1) Implementation of procurement, storage and distribution of medical devices must allow the inspection at anytime by the appointed officer.
(2) The inspection as meant in paragraph (1) includes inspection to the facilities and infrastructures of the Medical Device distributor, including its recording, procurement, storage and distribution.
(1) To obtain a Medical Device Distributor License, the Applicant must submit written application to the Director General via the Head of Local Provincial Health Service, by using example form as specified in attachments 17 and 18.
(2) The Head of Provincial Health Service not later than 12 (twelve) working days after receiving carbon copy from the applicant, coordinates with the Head of Regencial/Municipal Health Service to establish Joint Inspection Team to carry out on-site inspection.
(3) The Joint Inspection Team not later than 12 (twelve) working days, carries out inspection by using example form of Minutes of Inspection as specified in attachment 19.
(4) In the event of compliance, the Head of Provincial Health Service shall, not later than 6 (six) working days as of its receipt of inspection results from the Joint Examination team, pass it to the Director General, by using example form as specified in attachment 20.
(5) In case the inspection as meant in paragraphs (2) through (4) is not carried out on time the relevant applicant can make statement letter of readiness to carry out activity to the Director General with carbon copy to the Head of Provincial Health Service and the Head of local Regencial/Municipal Health Service by using example form as specified in attachment 21.
(6) Within 12 (twelve) working days as meant in paragraph (5) the Director General may take action as it deems necessary in the framework of deferment or refusal of application letter for Production Certificate by using example form as specified in attachment 22 or 23.
(7) Within 12 (twelve) working days as of the receipt of report of inspection results as meant in paragraph (4), the Director General shall issue the Medical Device Distributor License by using example form as specified in attachment 24.
(8) As to the deferment as meant in paragraph (6), an opportunity is given to complete the unmet requirements not later than 6 (six) month as of the issuance of the letter of deferment.
Application for licence to be branch and sub distributor of Medical Devices can only be conducted by:
(1) Sale of Medical Devices that may not result in hazards in its usage and that needs no health personnel supervision in their use can be conducted by Medical Device Stores.
(2) Pharmacies, licensed Drug Stores can sell Medical Devices as meant in paragraph (1).
Application for licence to be Medical Device Store can only be conducted by:
1. Legal Entity, Business Entity or individual;
2. Has adequate facilities and infrastructures to be a Medical Device store.
Medical Device Distributor License shall be valid as long as the appointment from factory (Principal) is still valid and the company is still active conducting business activities.
License for Distributor Branch, sub-branch shall be valid as long as the appointment as distributor of Medical Devices is still valid and the company still active conducting business activities.
Medical Devices the usage of which are under supervision of health personnel, are prohibited to be sold to the retailer, but must be directly to the health service facilities or to the competent health personnel.
(1) Delivery of Medical Devices is conducted for use in health services or for scientific interest.
(2) Certain Medical Devices that may result in risk in its delivery must be conducted to the entitled person.
(3) Further provisions as meant in paragraph (2) shall be regulated by the Minister.
(1) Marking and information on the Medical Devices and Household Health Supplies is conducted to protect the community from information of Medical Devices and Household Health Supplies that is non objective, incomplete and misleading.
(2) Marking of Medical Devices and Household Health Supplies can be in the forms of picture, colour, writing, or combination thereof or other forms that is furnished on the packing or inserted into the packing or constituting a part of its container and/ or packing.
Business entity circulating Medical Devices and Household Health Supplies must mention the marking, method of use and information on Medical Devices and Household Health Supplies in both Indonesian and English.
(1) Marking and information on Medical Devices and Household Health Supplies that must be mentioned as contemplated in article 63 must comply with the requirement, in writing form that contains particulars on the Medical Devices and Household Health Supplies objectively, completely and truthfully.
(2) Particulars as contemplated in paragraph (1) shall at least contain:
(3) Further provisions on marking, method of use and information to be included as contemplated in paragraph (1) and paragraph (2) are regulated by the Minister.
Advertisement of Medical Devices and Household Health Supplies to be circulated must contain information objectively, completely and truthfully.
Advertisement of Medical Devices and Household Health Supplies in any media that is used to disseminate information shall be conducted by observing advertisement ethics.
(1) Assessment of advertisement of Medical Devices and Household Health Supplies in order to protect the community from information that is misleading and incompliant to the advertisement ethics shall be conducted by a Team that is stipulated by the Minister.
(2) The Team as meant in paragraph (1) consists of experts and professional organizations, related associations, practicers and related agencies.
(1) In order to secure Medical Devices and Household Health Supplies meeting the quality, usefulness and safety requirements, efforts of quality maintenance of Medical Devices and Household Health Supplies shall be made.
(2) The efforts of quality maintenance of Medical Devices and Household Health Supplies as contemplated in paragraph (1) shall be made as from the production activity to the circulation of Medical Devices and Household Health Supplies.
(1) In the framework of making efforts of quality maintenance of Medical Devices and Household Health Supplies, the Minister stipulates:
(2) Implementation of provision as contemplated in paragraph (1) is regulated further by the Minister.
In order to assure quality, usefulness and safety of Electromedic and Radiology Medical Devices, tool calibration is necessarily carried out periodically in accordance with the prevailing provisions.
(1) Withdrawal of Medical Devices and Household Health Supplies from circulation due to its circulation licence revoked, shall be conducted by and become liability of the business entity that produces and/or circulates the Medical Devices and Household Health Supplies.
(2) Further provisions concerning procedure of withdrawal of Medical Devices and Household Health Supplies from circulation as contemplated in paragraph (1) are stipulated by the Minister.
Destruction of The Medical Devices and Household Health Supplies be conducted to the Medical Devices and Household Health Supplies that are:
(1) Destruction of Medical Devices and Household Health Supplies shall be conducted by business entity that produces and/or circulates the Medical Devices and Household Health Supplies and/ or person who is responsible for the health facility and/or the Government.
(2) Destruction of Medical Devices and Household Health Supplies related with the criminal offence shall be conducted by the government in accordance with the prevailing statutory regulations.
Destruction of Medical Devices and Household Health Supplies shall be conduced by paying attention its effects to human health and the efforts of living environment conservation.
(1) Destruction of Medical Devices and Household Health Supplies must be reported to the Minister.
(2) Report of destruction of Medical Devices and Household Health Supplies as contemplated in paragraph (1) shall contain at least information on:
(3) Report of destruction of Medical Devices and Household Health Supplies as contemplated in paragraph (2) shall be signed by the person in charge of technique and the witnesses in the implementation of destruction of Medical Devices and Household Health Supplies.
Further provisions concerning procedure of destruction and reporting of Medical Devices and Household Health Supplies as contemplated in articles 74 and 75, are stipulated by the Minister.
Community participation can be conducted by individuals, groups, or community based institutions.
(1) The community participation shall be aimed to improve and empower the existing ability of the community in the framework of safeguarding of Medical Device and Household Health Supplies.
(2) Implementation of community participation as meant in paragraph (1) is regulated by the Minister.
The Minister conducts fostering to all activities relating with the Medical Device and Household Health Supplies.
(1) The Fostering as meant in Article 83 is aimed at:
(2) Fostering as meant in paragraph (1) shall be conducted in the fields of:
(3) Fostering of implementation of this provision and advertisement shall be conducted in levels from Central to Regional levels.
Supervision to all activities to all activities that relate to the safeguarding of Medical Device and Household Health Supplies shall be conducted in levels from Central level by the Director General to Regional level by the Head of Provincial and or Regencial/Municipal Health Service.
The Regencial/Municipal Health Service and the Provincial Health Service shall in levels report the fostering and supervision results that have been conducted to the Director General.
Any breach of the provisions in this Regulation shall be subjected to administrative sanction in the form of verbal warning, written warning until revocation of license as specified in attachment 25.
(1) Any breach of this provision that result in someone has health disorder, disabled or die shall be subjected to imprisonment.
(2) Imprisonment as meant in paragraph (1) shall be imposed based on the prevailing statutory regulations.
(1) Production Licence, Circulation Licence of Medical Devices and Household Health Supplies and Distributor Licence of Medical Devices that has been issued based on Regulation of the Minister of Health No. 220/Men.Kes/Per/IX/1976, No. 236/Menkes/Per/X/1977, No. 140/Menkes/Per/III/1991, and No. 142/Menkes/Per/III/1991, are declared remain valid as long as not in contrary to this regulation.
(2) Adjustment to paragraph (1) that does not comply with this regulation shall be conducted within not later than 1 (one) year as of the stipulation of this regulation.
With the enforcement of this Government Regulation, Regulations of the Minister of Health of the Republic of Indonesia No. 220/Men.Kes/Per/IX/76 Concerning Production and Circulation of Cosmetics and Medical Devices, No. 236/Men.Kes/Per/X/1977 on Permits of Cosmetic Products and Medical Devices, No. 140/Men.Kes/Per/III/1991 on Compulsory Registration of Medical Devices, Cosmetics and Household Health Supplies, No. 142/Men.Kes/Per/III/1991 on Distributor of Medical Devices, are revoked and declared null and void.
This Regulation comes into force as from the date of stipulation.
For public cognizance, this Regulation shall be announced by placing it in State Gazette of the Republic of Indonesia.
Stipulated in Jakarta
on October 19, 2004
THE MINISTER OF HEALTH,
Ttd.
Dr. Achmad Sujudi
Attachment to REGULATION OF THE MINISTER OF HEALTH
No. 1184/MENKES/PER/X/2004