REGULATION OF THE MINISTER OF HEALTH
No. 140/Menkes/Per/III/1991

ON
THE OBLIGATION TO REGISTER HEALTH EQUIPMENT, COSMETICS AND
HOUSEHOLD HEALTH SUPPLIES

THE MINISTER OF HEALTH OF THE REPUBLIC OF INDONESIA,

Considering :

• a. that with a view to protecting the public from health hazards, it is necessary to prevent the circulation of health equipment, cosmetics and household health supplies which fail to meet relevant requirements;
• b. that for this purpose it is necessary to conduct registration and evaluation before the distribution of health equipment, cosmetics and household health supplies;
• c. that in order to serve applicants in the best possible manner, the process of registration should be simplified and sped up without reducing requirements for the safety and quality of health equipment, cosmetics and household health supplies as well as the benefit of health equipment;
• d. that it is therefore deemed necessary to restipulate provisions concerning the registration of health equipment, cosmetics and household health supplies.

In view of :

• 1. Law No. 9/1960 on the principles of health (Statute Book of 1960 No. 131, Supplement to Statute Book No. 1068);
• 2. Law No. 7/1963 on pharmacy (Statute Book of 1963 No. 81, Supplement to Statute Book No. 2580);
• 3. Government Regulation No. 7/1973 on the control of the distribution, storage and use of pesticides (Statute Book of 1973 No. 12);
• 4. Government Regulation No. 11/1975 on working safety against radiation (Statute Book of 1975 No. 15, Supplement to Statute Book No. 3051);
• 5. The Regulation of the Minister of Health No. 220/Menkes/Per/IX/1976 on the production and distribution of cosmetics and health equipment;
• 6. The Regulation of the Minister of Health No. 220/Menkes/Per/XI/1983 on hazardous materials.

DECIDES :

To stipulate :

THE REGULATION OF THE MINISTER OF HEALTH CONCERNING THE OBLIGATION TO REGISTER HEALTH EQUIPMENT, COSMETICS AND HOUSEHOLD HEALTH SUPPLIES.

CHAPTER I
GENERAL PROVISIONS

Article 1

Hereinafter referred to as :

• 1. Health equipment shall be materials, instruments, apparatuses, machines, devices for planting, reagents/ in vitro diagnostic products or other similar or relevant goods including components, parts and accessories which :
• 1.1 are mentioned in the Pharmacopoeia of Indonesia, Extra Pharmacopoeia of Indonesia and National Formulary or their supplements and/or
• 1.2 are used for diagnosis, cure, health care, restoration, relief or prevention of human diseases and /or
• 1.3 are meant to affect the structure and function of the human body and/or,
• 1.4 are meant to diagnose non pathological conditions; and which in achieving their main aims:
• 1.5 do not undergo chemical reactions in the human body and/or,
• 1.6 do not rely on body metabolism,
• 2. Cosmetics shall be preparations or combinations of materials ready for use on outer body parts (epidermis, hair, nails, lips and external sexual organs), teeth and inner mouths, for cleansing, enhancing attractiveness, changing appearance, maintaining a good condition, improving body odour but not for curing or healing diseases.
• 3. Household health supplies shall be devices, materials or mixtures for the health maintenance and care of humans, domestic animals, households and public places.
• 4. Markings shall be labels, brochures or other written, printed or illustrated statements containing sufficient information, which accompany or are connected with health equipment, cosmetics and household health supplies.
• 5. The Director General shall be the Director General of Food and Drug Control.
• 6. The Minister shall be the Minister of Health of the Republic of Indonesia.

CHAPTER II
REQUIREMENTS AND CRITERIA

Article 2

Health equipment, cosmetics and household health supplies which are distributed or sold within the territory of Indonesia shall be registered at the Ministry of Health in this case the Directorate General of Food and Drug Control.

Article 3

(1) The registration of domestically produced health equipment shall be done by licensed producers of dome tic health equipment.

(2) The registration of domestically produced cosmetics or household health supplies shall be done by :

(3) The registration of imported health equipment shall be done by distributors of health equipment authorised by overseas producers.

(4) The registration of imported cosmetics or household health supplies shall be done by distributors approved or authorised by overseas producers or companies.

Article 4

Health equipment, cosmetics and household health supplies being registered shall meet the following requirements :

• a. Effectiveness and safety
• 1. For health equipment :
• Sufficiently effective and safe, as evidenced by clinical tests or other proofs paralleled to the status of the scientific development concerned.
• 2. For cosmetics:
• Sufficiently safe, i.e. not using prohibited materials; not exceeding limits of grades for materials. preservatives and sunscreens permitted with restrictions; using colourings permitted according to areas of application.
• 3. For household health supplies :
• Sufficiently safe, i.e. not using prohibited materials and not exceeding limits of grades already determined.
• b. Quality
• Fulfilling requirements as evaluated from the application of proper production methods and the use of materials only with appropriate specifications for health equipment, cosmetics and household health supplies.
• c. Markings
• 1. For healthy equipment and cosmetics :
• Containing sufficient information which can prevent misunderstanding or misuses.
• 2. For household health supplies :
• Containing sufficient information which can prevent misunderstanding or misuses, including warning marks and instructions to overcome accidents.

CHAPTER III
PROCEDURE FOR REGISTRATION

Article 5

(1) Applications for the registration of health equipment, cosmetics and household health supplies shall be submitted to the Director General.

(2) Applications for the said registration shall be filed by completing registration forms and attaching documents as required by the Director General.

Article 6

(1) Health equipment, cosmetics and household health supplies whose applications have met the requirement as meant in Article 7 paragraph (2) shall be subject to evaluation with regard to their safety, quality and markings.

(2) For imported health equipment, cosmetics and household health supplies already circulating in their originating countries with appropriate systems of supervision, evaluation shall only be conducted on their safety and markings.

Article 7

(1) In case additional data are needed for evaluation, the Director General shall make notifications in writing by using the model form shown in Attachment I.

(2) Registrants shall submit additional data as meant in paragraph (1) not later than 3 (three) months starting from notification dates.

(3) In case registrants fail to meet the provision as meant in paragraph (2), the Director General shall is sue letters of rejection of registration by using the model form shown in Attachment II.

(4) The rejected registration as meant in paragraph (3) can be reapplied for as new registration if the documents as meant in Article 5 paragraph (2) and/or additional data as meant in paragraph (2) are supplied.

Article 8

(1) Not later than 3 (three) months for health equipment and 2 (two) months for cosmetics and household health supplies starting from the receipt of complete applications, the Director General shall approve or reject the registration applied for.

(2) Decisions on the registration of health equipment, cosmetics and household health supplies as meant in paragraph (1) shall be valid for an unlimited period. Model forms for this purpose are as shown in Attachments III, IV, V and VI according to the kinds of goods registered.

The rejected registration as meant in paragraph (1) can be reapplied for as new registration if new data are available to support approval.

Article 9

The registration of health equipment, cosmetics and household health supplies shall be exempted from fees.

CHAPTER IV
CANCELLATION OF REGISTRATION APPROVAL

Article 10

(1) The Director General may cancel approval for registration if based on post-registration observation or monitoring of their use, the goods concerned fail to meet the criteria as meant in Article 4 or create health hazards.

(2) The cancellation of approval as meant in paragraph (1) shall be done by using the model form shown in Attachment VII.

CHAPTER V
REP0RTS

Article 11

(1) Companies registering health equipment, cosmetics and household health supplies shall submit annual reports on the kinds and side effects of the health equipment, cosmetics and household health supplies they have produced.

(2) The reports as meant in paragraph (1) shall be compiled by using the model forms shown in Attachments VIII and IX.

CHAPTER VI
C0NCLUSI0N

Article 12

With the issuance of this ministerial regulation, the Regulation of the Minister of Health No.326/Menkes/Per/XII/1976 on the obligation to register cosmetics and health equipment shall be declared null and void.

Article 13

Technical matters which are not yet regulated in this ministerial regulation shall be further stipulated by the Director General.

Article 14

This regulation shall come into force as from the date of stipulation.

For public cognizance, this ministerial regulation shall be announced by publishing it in the State Gazette of the Republic of Indonesia.

Stipulated in Jakarta
On March 4, 1991

THE MINISTER OF HEALTH OF THE REPUBLIC OF INDONESIA
Sgd.
Dr. ADHYATMA, MPH

Attachment (in BPOM's Website : http://www.pom.go.id/)