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CHAPTER III
EDAR PERMIT REQUIREMENTS FOR MEDICAL DEVICES NEW

A. General

Terms of the marketing authorization of medical devices consist of administrative requirements

and technical requirements and attached to the five (5) forms, namely:

1. Form A is the administrative

2. Form B is Product Information
3. Form C is Information Specifications and Product Warranty
4. Form D which uses information and how to use
product
5. Form E is System Post Market Surveillance

B. Application Requirements
1. To Form A (Administration) There is some
requirements between domestic products and imported products.
2. For Form B, C, D and E requirements in the medical devices
domestic and imported alike
3. Some specific medical devices must meet the requirements
such specialized medical devices containing ionizing materials must obtain a permit from
BAPETEN
4. Form A, B, C, D and E must be filled in correctly

Table 2. Form A (Medical Device Imports)

NO FORM A CLASS
A B C D
ADMINISTRATIVE DATA REQUIREMENTS
(I) (IIA) (IIB) (III)
1 Licensed distributors of medical devices issued by the Health Minister cq
√ √ √ √
Director General of Pharmaceutical and Medical Devices and valid

Ipak must specify the type of medical equipment that may be disbursed
according to the ability of the following means:

a. Non-sterile non elektromedik Alkes

b. Sterile non elektromedik Alkes
c. Alkes non radiation elektromedik
d. Alkes radiation elektromedik
e. IV Diagnostic and Reagensia
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2 The power of attorney as sole agent or sole distributor

who are authorized to register medical devices from the principal / plant √ √ √ √
origin which legalized the Embassy
local

Conditions LOA / power of attorney

a. Must include the trade name and the name
the type of products that are allowed to mediated
b. LOA minimum validity period is 2 (two) years
c. Could come from: Plant of origin / principal or
Representative / office representatives, be equipped
by letter description of the relationship / job
same / designation of origin or principal factory with representative

d. Distributor agreement / cooperation agreement

required if the LOA less than 2 (two) years or
does not specify a period of validity of the agency

Term which can be received in the mail

appointment:
• Sole Agent, Exclusive Distributor, Sole Distributor
• Representative ( representatives / branch), Distributor, and Non
Exclusive distributors are allowed but must include a power of
attorney to sign up from the principal / plant and name the products
that are listed

3 Certificate of Free Sale ( CFS):

√ √ √ √
a. Explain that the name and type tool
Health has been produced / registered (name
factory) and circulated in the country of origin of the plant / legal
manufacturer
b. Issued by the Ministry of Health
local or competent authority in the country of origin

c. Still valid

4 Certification and documents that mention

√ √ √ √
conformity to product standards, terms of safety, effectiveness and quality
systems in the design and manufacturing process (ISO 13485, CE
certificate) as follows:

a. Still valid
b. Is given by Notified body
c. Outlines the types of products that are listed
d. CE certificate must be attached if the
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brochures or manuals or other markings include the "CE"
numbered

5 exclusive summary ( Executive summary) contain - -√ √

information:
a. A quick review of the description of the appliance
its mechanisms and their health
b. Marketing history, mentioning the country
where the product already has a marketing authorization and the year of
issuance. If you do not already have a marketing authorization from another
state that is recognized should provide information about the status of
waiting for the marketing authorization of these products

c. Intended use and indications

d. Important information security and performance tools

6 Standard is used and evidence of compliance

-√ √ √
to standards on the production / manufacture of medical devices ( Declaration
of Conformity)
of factory

7 Patent Trademark:
√ √ √ √
a. Issued by the Ministry of Justice and Human Rights
valid and include the name of the brand owner in accordance with
the company's name or company leaders

b. Statement of willing to remove the brand &

restore a marketing authorization if it does not have a patent or
trademark is still in the registration process above stamp Rp. 6000

c. For OEM products ( Original Equipment

Manufacturer). If the name does not match the brand owner, attach a
letter of appointment / power use of the brand stamped Rp. 6000

8 Statement Release Agent. Ejected

√ √ √ √
by the company distributor of medical devices and include the name of
the product and the name and address of the manufacturer stamped
Rp.6000
9 Statement agreed to meet the requirements
√ √ √ √
quality security and benefits and are willing to be rejected if the
documents / data that is uploaded is not appropriate or file the original
and does not meet the requirements.
Affidavit signed
Director / undertaking technical listed on Production Certificate stamped
Rp.6000