Establishment Company for Medical Equipment
What are the requirements for making a
company in the field of health tools?
In
the midst of the COVID-19 pandemic situation that is being experienced in
Indonesia, the government finally implemented the PSBB (Large-Scale Social
Restrictions). In this situation, many employees experience working from home
which is commonly called WFH (Work From Home) and not a few also experience
layoffs (layoffs).
This
Corona Virus pandemic has resulted in the disruption of almost all business
industries from various sectors which have caused many companies to experience
a decrease in turnover in this pandemic situation, this is a very tough
challenge for the future where apart from facing this Corona Virus pandemic.
However, during this pandemic, the business that has the opportunity to develop
is in the health sector. To be able to do business in the field of medical
equipment (Alkes), the permits that need to be needed are a Medical Device
Distribution Permit and a Medical Device Distributor (IPAK).
How do you get a Medical Device
Distribution Permit and a Medical Device Distributor Permit (IPAK)?
A. How to get a Medical Devices
Distribution Permit
Domestic
or foreign medical devices or Household Health Supplies (PKRT) must have a
distribution permit from the Ministry of Health before circulating in the
community. If you have registered, there will be an evaluation for safety,
usefulness, and quality. If medical devices or Household Health Supplies (PKRT)
do not have a distribution permit, then their safety and quality cannot be
accounted for.
1. The registration method is easy, namely:
2. Login once through the website
www.regalkes.depkes.go.id.
3. The applicant fills in the registration form
to get a username and password.
4. The applicant verifies the files at the
Technical Implementation Unit (UPT) counter.
5. The applicant makes a Non-Tax State Recipient
(PNPB) payment at the bank designated by the counter.
6. The applicant takes the certificate at the
Technical Implementation Unit (UPT) counter.
B. How to get a PAK Permit
The
purpose of requiring Medical Device Companies to have Medical Device Distribution
Permits (IPAK) is to carry out the distribution process of medical devices to
comply with the guidelines. This is to maintain the safety, quality and
benefits (safety, quality, and efficacy) of imported and domestic medical
devices circulating in Indonesia along the distribution chain. As written in
Permenkes RI No. 1191 / Menkes / Per / VIII / 2010 concerning Distribution of
Medical Devices (PAK), Article 1 number 1,2,3 states that Medical Devices are
instruments, apparatus, machines and / or implants that do not contain drugs
used to prevent, diagnose, heal and alleviate disease, care for the sick,
restore health in humans, and / or structure and improve bodily functions.
Requirements
and Procedures for Applying for Medical Device Distributor License (IPAK) must
meet the following requirements:
1. The company is a legal entity and has obtained
a business license.
In accordance
with the provisions of laws and regulations and make sure your company has a
Business Identification Number (NIB).
2. Has a person in charge of technical personnel
who work fully, with appropriate education with the terms
and conditions that apply.
Having facilities
and infrastructure in the form of adequate space and other equipment for
administrative offices and warehouses with the status of their own, contract or
lease for at least 2 (two) years.
3. Own a workshop / workshop or cooperate with
other companies in implementing it after-sales
guarantee, for companies that distribute medical devices that need them.
4. Meet the Good Medical Device Distribution
Method (CDAKB).
To
be granted a Medical Device Distribution Permit (IPAK), the applicant must
follow the following procedures:
1. Applicants must register the company to get a
user id and password through online registration at the Online Medical Device
and Household Health Supplies (PKRT) Registration Application at
http://www.regalkes.depkes.go.id. This system was built to facilitate public
services in the licensing process that issued Medical Devices and Household Health
Supplies Production Certificates (PKRT), Medical Device Distributor Permits
(PAK Permits) as well as Circular Permits for Medical Device Products and
Household Health Supplies (PKRT).
2. Applicants must complete all requirements
through online registration.
3. Applicants who carry out the licensing process
at the Integrated Service Unit must bring an Identification Card (ID Card) from
Dit. Medical Devices Prodis Development or a power of attorney from the
company.
PAK
permits, both new and data changes, are valid as long as they meet the
following requirements:
a) Implement the provisions of the CDAKB (Good
Medical Device Distribution Method).
b) The company is still actively conducting
business activities.
c) The Director General conducts a comprehensive
audit of the PAK at the latest every 5 (five) years in accordance with the
CDAKB (Proper Medical Device Distribution Method).
A
good medical equipment distribution facility must have an organizational
structure, consisting of at least a Director, Technical Responsible Officer,
Warehouse Officer, and technician.
1) There must be a policy issued by the
leadership of the organization for the distribution of medical devices,
including:
-
Statement for
standards of organizational activities.
-
Professional
organizational practice.
-
Organizational
goals, products that are distributed according to the requirements during the
distribution process to customers / consumers.
2) There is a guidebook that contains the
organization's profile
-
Organizational
structure.
-
Main duties of
each personnel.
-
Quality plan.
3) There is a Permanent Procedure (PROTAP) for
each stage of the activities required by the organization to ensure the
planning, operation and control of the distribution process effectively.
4) Written procedures in the form of work
instructions for each activity.
5) Work records.
6) Other documents specific to each medical device.
Write by Anna