Updated: 01/19/01.

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The Indonesian Director General of Food and Drugs (Indonesian acronym: DirJen POM, the local analogue to the U.S. Food and Drug Administration) within the national Ministry of Health controls the registration of medical devices, cosmetics and household health supplies in Indonesia. To protect consumers from unsafe medical devices, cosmetics and household supplies, DirJen POM has issued regulation No. 140/Menkes/Per/III/1991 on the "Obligation to Register Medical Devices, Cosmetics, and Household Health Supplies." To implement that regulation, DirJen POM has issued implementing regulation No. 1477/C/SK/IV/91, "Directives for Registration of Medical Devices, Cosmetics and Household Health Supplies."

This is Part 1 of a series of U.S. Commercial Service (Jakarta office) reports on the directives for the Registration of Medical Devices, Cosmetics and Household Health Supplies. This report focuses primarily on imported products and does not include full instructions for registering domestic (i.e., Indonesian-made) medical devices. The full series consist of the following:

1. Directives on Registration of Medical Devices

2. Directives on Registration of Cosmetics

3. Directives on Registration of Household Health Supplies.

This report summarizes the Directives on Registration of Medical Devices (regulation No. 1477/C/SK/IV/91)

I. STIPULATION ON REGISTRATION IMPLEMENTATION

1. Registration Applicants

a. Registration of domestically- produced medical devices shall be done by licensed local manufacturers;

b. Registration of imported medical devices shall be done by local distributors of medical devices that possess authorization from overseas manufacturers. To register, overseas companies may only appoint or give authorization to one local distributor for parts or all types of equipment produced by the companies.

2. Method of Registration

a. Applicants must fill out application forms and submit the forms to the DirJen POM, Directorate for Drug and Medical Devices Control at Jl. Percetakan Negara 23, Jakarta 10560, Indonesia; upon which applicants will be given a receipt.

b. Applicants will be notified if forms are incomplete.

3. Application Forms

a. Applicants must fill out application forms to register domestically-produced medical devices.

b. Applicants shall use one registration form to register reagent/in vitro diagnostic products that have the same formula, labeling and packaging materials, but of different sizes or packaging materials that do not effect the stability of the products.

c. Applicants shall use one registration form to register scissors, tweezers or other medical devices that fall under the same category.

d. Applicants shall use one registration form to register disposable products such as sanitary napkins or plasters of different sizes, but having the same materials and labeling.

e. Forms must be filed in triplicate. The first and second copies shall be submitted to the Directorate for Drug and Medical Devices Control, and the third copy shall be kept by the applicant.

f. Applicants must provide truthful information on the materials used in the formula, components, product specifications, production methods (for reagent or in vitro diagnostic products), finished product specifications, stability (for in vitro diagnostic medical devices and syringes), functions, methods, and labeling including labels, brochures and other information on the products.

g. The main application forms must be filled out in Indonesian. Supporting data and documents (enclosures) must be in Indonesian or English.

4. Registration Evaluation

Prior to obtaining a registration number, applications shall be evaluated according to Regulation no. 140/Menkes/Per/III/1991.

5. Evaluation Result

a. Applications are considered complete if application forms and enclosures are filled out correctly according to the instructions.

b. Applications are incomplete if application forms are incorrectly filled out.

6. Decision Making on Registration

a. On behalf of the Ministry of Health, DirJen POM shall make the decision on the application. The decision will be issued at the latest 3 months after the complete application is received.

b. The decisions are as follows:

(1) A registration number will be given when an application is approved. This number will be valid for an unlimited period unless changes are made to the approved application data. Registration numbers for domestically-produced medical devices will use code KD; and for imported equipment, code KL.

(2) Completion of Data:

(a) DirJen POM will notify applicants in writing if, after the evaluation, additional data are required;

(b) The additional data must be submitted at the latest 3 months from the date of notification.

(c) The additional data will be reevaluated and a registration number will be given if the data is complete.

(d) Failure to provide the data will result in the rejection of the application.

(e) Applicants may re-submit a new application by fulfilling the incomplete data requested by DirJen POM.

(3) Registration Rejection:

The DirJen POM will notify in writing when a request for registration is rejected. Other than the criteria mentioned above, applications may be rejected because of:

(a) failure to fulfill the restrictions or the criteria for medical devices.

(b) use of a product name that is the same as the name of a product that has already been registered.

(c) incorrect additional data.

7. Product Data Changes

a. If there are changes in the formula, materials, labels, packaging or other factors after the medical device has obtained a registration number, the applicant must register these changes by filling out the Data Changes Application forms.

b. Applications for changes will be evaluated according to regulation No. 140/Menkes/Per/III/1991, and the result will be notified in writing.

8. Increase in the Size of Packaging

Applicants must fill out a Packaging Size Increase Report form for medical device that has already obtained a registration number, but for which an increase in the packaging size is desired.

9. Cancellation of Approved Registration

The Director General can cancel the registration number, if any of the following takes place:

a. Based on the request of the applicants;

b. Based on evaluation or monitoring, products fail to meet the criteria because:

(1) they are not safe or are harmful to health,

(2) the quality is substandard,

(3) they differ from the approved label; this includes using a brand name which is originally owned by another rightful party;

The Director General will notify the registration holder in writing of the cancellation.

10. Re-registration

a. Medical devices that have obtained a registration number prior to the issuance of Regulation No. 140/Menkes/Per/III/1991 must re-register and fill out an application form.

b. Re-registration will be done in stages, and will be notified through Circular Letter.

II. MEDICAL DEVICES CATEGORIES AND SUB-CATEGORIES

1. Clinical Chemistry and Toxicology Equipment

a. Clinical chemistry tests

b. Clinical laboratory equipment

c. Clinical toxicology tests

2. Hematology and Pathology Equipment

a. Biological coloring

b. Culture media and tissue products

c. Pathology equipment and accessories

d. Reagent specimens

e. Automatic & semi-automatic hematology

equipment

f. Manual hematology equipment

g. Hematology packets

h. Hematology reagents

i. Products used for making blood preparation,

and preparations originating from blood

3. Immunology and Microbiology Equipment

a. Diagnostic equipment

b. Microbiology equipment

c. Serology reagents

d. Immunology laboratory reagent and equipment

e. Immunological tests

f. Immunology tumor antigen tests

4. Anesthesia Equipment

a. Anesthesia diagnostic equipment

b. Anesthesia monitoring equipment

c. Anesthesia therapeutic equipment

d. Other anesthesia equipment

5. Cardiology Equipment

a. Cardiology diagnostic equipment

b. Cardiology monitoring equipment

c. Cardiology prosthetic equipment

d. Cardiology surgical equipment

e. Cardiology therapeutic equipment

6. Dental Equipment

a. Dental diagnostic equipment

b. Dental prosthetic equipment

c. Dental surgical equipment

d. Dental therapeutic equipment

e. Other dental equipment

7. Ear, Nose and Throat (ENT) Equipment

a. ENT diagnostic equipment

b. ENT prosthetic equipment

c. ENT surgical equipment

d. ENT therapeutic equipment

8. Gastroenterology-Urology (GU) Equipment

a. GU diagnostic equipment

b. GU monitoring equipment

c. GU prosthetic equipment

d. GU surgical equipment

e. GU therapeutic equipment

9. General & Private Hospital (G&PH) Equipment

a. G&pH monitoring equipment

b. G&pH therapeutic equipment

c. Other G&pH equipment

10. Neurology Equipment

a. Neurology diagnostic equipment

b. Neurology surgical equipment

c. Neurology therapeutic equipment

11. Obstetric and Gynaecology (OG) Equipment

a. OG diagnostic equipment

b. OG monitoring equipment

c. OG prosthetic equipment

d. OG surgical equipment

e. OG therapeutic equipment

12. Optical Equipment

a. Optical diagnostic equipment

b. Optical prosthetic equipment

c. Optical surgical equipment

d. Optical therapeutic equipment

13. Orthopaedic Equipment

a. Orthopaedic diagnostic equipment

b. Orthopaedic prosthetic equipment

c. Orthopaedic surgical equipment

14. Physical Health Equipment

a. Physical health diagnostic equipment

b. Physical health prosthetic equipment

c. Physical health therapeutic equipment

15. Radiology Equipment

a. Radiology diagnostic equipment

b. Radiology therapeutic equipment

c. Other radiology equipment

16. General Surgery and Plastic Surgery Equipment

a. General & plastic surgery diagnostic equipment

b. General & plastic surgery prosthetic equipment

c. General & plastic surgery surgical equipment

d. General & plastic therapeutic equipment

III. APPLICATION FORMS FOR REGISTRATION OF IMPORTED MEDICAL DEVICES

The application for registration requires:

a. Name of Indonesian company which possesses distributor license for medical devices

- complete address and telephone;

b. Name of factory or overseas company that gives authorization to register the device

- complete address;

c. Brand name of the medical device;

d. Category and sub-category of the medical device;

e. Other information (shape, color, net weight, volume, packaging, sizes, types, components, etc) ;

f. Applications shall include the following enclosures (obtainable from DirJen POM):

- Enclosure AA: Formula and Components

- Enclosure BB: Specification and Quality Assurance

- Enclosure CC: Usage and Labelling

- Enclosure DD: Catalog and Sample

- Additional information

Instructions for filling out application forms for imported medical devices:

a. Name of company that is applying for registration.

(1) Insert name of Indonesian company according to the medical device distributor license. Enclose photocopy of the distributor license.

(2) Complete address and telephone number. Include P.O Box if available.

b. Insert name of factory or overseas company that gives the authorization to register. Provide complete address and PO Box if available. Enclose:

(1) Photocopy of authorization letter from the factory or the overseas company that requests registration of products at the Indonesian Ministry of Health.

(2) Factory organizational structure.

c. Brand name of medical devices shall correspond to labeling (labels, brochures or manual). Explain whether medical devices have been officially traded overseas. Name the countries where the equipment has been traded. Enclose official information from the country of origin indicating that:

(1) the factory has fulfilled all criteria to produce medical devices according to the law of the country-of-origin, and/or;

(2) the medical devices have been legally distributed in the country of origin, and/or;

(3) the medical devices have been exported to countries that are recognized for their control systems. Indicate names of the countries. This information must be approved officially by the country of origin and acknowledged by the Indonesian Embassy in that country.

d. Category and Sub-category

Indicate the category and sub-category accordingly (see section II above).

e. Other description of the device.

- Shape : solid, liquid, instrument, etc.

- Color : color preparations

- Packaging : describe for packaged medical devices

- Weight/Size : indicate, if available

- Type : indicate, if available

- Components : indicate, if available

f. Enclosures shall be original official application forms. Forms shall include enclosures AA, BB, CC and DD (one copy of each). Applicants may use additional forms if one copy of the form is insufficient.

g. Application forms must be signed by the head of the company, the director or technical representative as indicated in the distributor license. Indicate name of place, date, complete name and company's seal.

Note regarding Enclosure CC:

1. Provide information on product usage.

2. Enclose the equipment manual.

3. Product coding and meaning. Give examples on the product coding and explain its meaning.

4. Labeling, including container labels, packaging, brochures, and other accompanying writings.

Enclose: the label and packaging, brochures and writings that accompany the product.

For the enclosures, the use of any foreign language other than English shall be translated to Indonesian or English.

Note: The U.S. Commercial Service (CS) Commercial Center in Jakarta and the CS office in Surabaya offer a variety of resources and services to assist U.S. companies entering or expanding in Indonesia. For further information about these services, or about the information contained in the report above, you may contact Ms. Sharon Chandra at Sharon.Chandra@mail.doc.gov or at telephone (62-21) 526-2850 ext. 3007. The Jakarta Commercial Center fax number is (62-21) 526-2855. The Surabaya office fax number is (62-31) 567-7748. For a broad range of related information, visit the U.S. Commercial Service's web-site at www.jakarta.uscc.org .

Appendix 1: For more information, read the 2005 Commercial Service Report "Indonesia's Analytical and Clinical Chemistry Market or Indonesia Clinical Laboratory Equipment".