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Licensing

INSPIRY assists you in obtaining company certification, company permit, product registration, and hospital or clinic license that is in line with government regulations and directly increases company credibility.

Set Up New Business

Business Permit

NOTARY DEED
TAX
Domicilie
KBLIStandardized Classification of Business Field in Indonesia
NIBBusiness Identification Number

Operating Permit

HOSPITAL LICENSE
HEALTH EQUIPMENT MANUFACTURING LICENSE
CLINIC LICENSE
IDAK
COSMETIC LICENSE
LAB LICENSE
PBF
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License Holding

License holding will act as the official license holder for a device, assisting in obtaining and maintaining regulatory approvals and compliance with local regulations, especially for companies who wants to market their product in regions without a physical presence.

What You Will Get:

Regulatory Consultation

We are familiar with the legal specifications that are frequently involved in license holding services. We help the manufacturer navigate the regulatory process and keep up with any changes to the laws.

Submission and Approval

We help our clients for their product to be approved by the regulatory bodies by helping to prepare and submit it. This entails gathering clinical data, technological files, and other necessary information.

Interaction with the Authorities in Charge of Regulation

On behalf of the manufacturer, the license holder serves as the main point of contact with regulatory bodies. They deal with correspondence, questions, and any updates or changes that should be made to the regulatory submissions.

What is the benefit:

  • Low investment
  • Simple Procedure
  • Flexibility
  • Faster Market Entry

International Standard License

ISO Certification


QUALITY MANAGEMENT SYSTEM

ISO 9001 - 2015

QUALITY MANAGEMENT SYSTEM

In order to increase customer trust and satisfaction, as well as motivate employees and create a culture of continuous improvement and improve product and process quality assurance.

ANTI-BRIBERY MANAGEMENT SYSTEMS (ABMS)

ISO 37001 - 2016

ANTI-BRIBERY MANAGEMENT SYSTEMS (ABMS)

Assist organizations in implementing an anti-bribery management system and provide assurance to management, organization owners, shareholders, customers, and other business partners.

OCCUPATIONAL HEALTH AND SAFETY

ISO 45001 - 2018

OCCUPATIONAL HEALTH AND SAFETY

Able to reduce the number of workplace accidents as well as take into account the risks and hazards so as to strive for continuous improvement. Also, there are legal and other requirements related to the OSH management system.

FOOD SAFETY QUALITY MANAGEMENT SYSTEM

ISO 22000 - 2018

FOOD SAFETY QUALITY MANAGEMENT SYSTEM

Demonstrate a real commitment to global food safety that ensures proper consumption of food and beverages so as to gain the trust of national & international customers.

ENVIRONMENTAL MANAGEMENT SYSTEM

ISO 14001 - 2018

ENVIRONMENTAL MANAGEMENT SYSTEM

Helps save costs in handling waste and reduces negative impacts on the environment due to operational activities such as waste pollution and efficiency of energy resources. This will improve the company's image from a public perspective and strengthen relations with regulators, investors, and potential creditors.

MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEM

ISO 13485 - 2016

MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEM

An organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer needs and applicable regulatory requirements. This includes the design and development, manufacture, storage and distribution, installation, or servicing of medical devices.

MAIN STANDARD FOR TESTING AND CALIBRATION LABORATORIES MANAGEMENT SYSTEM

ISO 17025 - 2017

MAIN STANDARD FOR TESTING AND CALIBRATION LABORATORIES MANAGEMENT SYSTEM

Useful for doing tests, sampling or calibration, and want reliable results. This includes all types of laboratories, whether owned and operated by the government, industry, or other organizations.

STERILIZATION OF HEALTH-CARE PRODUCTS

ISO 11135 - 2014

STERILIZATION OF HEALTH-CARE PRODUCTS

Specifies requirements for the development, validation, and routine control of an ethylene oxide sterilization process for medical devices in both the industrial and healthcare facility settings.

Medical Devices - Application Of Risk Management To Medical Devices

ISO 14971 - 2015

Medical Devices - Application Of Risk Management To Medical Devices

To set a process for manufacturers to identify the hazards associated with medical devices, including in vitro diagnostic medical devices (IVD), to estimate and evaluate the risks to those products, to control these risks, and to monitor the effectiveness of controls.

Information Security Management System

ISO 27001 - 2013

Information Security Management System

Determine the requirements for establishing, implementing, maintaining, and continuously improving an information security management system within an organizational context.

MINISTRY OF HEALTH & BPOM

(Submitted Within 1 - 2 Month)

1

CDAKB

Good Distribution Practices of Medical Devices

2

CPAKB

Good Medical Devices Manufacturing Practices

3

CDOB

Good Distribution Practices of Medicines

PRODUCT REGISTRATION

(Submitted Within 1 Month)

AKD / AKL / PKD / PKL

Medical Devices Product License

TKDN

Domestic Component Level

SNI

Indonesian National Standard

COMPANY LICENSE

(Submitted Within 1 Month)

Notarial Deed / NIB / KBLI

Bussiness Permit

IDAK

License of Medical Device Distribution

PBF

License of Medicine

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Quality Improvement Program
for Hospital

Quality Improvement Program for Hospitals offers various certification and training services that enhance the capability and skills of management and all hospital personnel in supporting the quality and operation of the hospital,since it directly affects the effectiveness of operations, patient satisfaction, healthcare service quality, and overall facility success.

Training Registration Form

ISO Certification for Hospital

ISO Certification


QUALITY MANAGEMENT SYSTEM

ISO 9001 - 2015

QUALITY MANAGEMENT SYSTEM

STERILIZATION OF HEALTH-CARE PRODUCTS

ISO 11135 - 2014

STERILIZATION OF HEALTH-CARE PRODUCTS

OCCUPATIONAL HEALTH AND SAFETY

ISO 45001 - 2018

OCCUPATIONAL HEALTH AND SAFETY

Information Security Management System

ISO 27001 - 2013

Information Security Management System

ENVIRONMENTAL MANAGEMENT SYSTEM

ISO 14001 - 2015

ENVIRONMENTAL MANAGEMENT SYSTEM

FOOD SAFETY MANAGEMENT

ISO 22000

FOOD SAFETY MANAGEMENT

ANTI-BRIBERY

ISO 37001 - 2016

ANTI-BRIBERY

Quality Assurance For Medical Laboratories

ISO 13485 - 2022

Quality Assurance For Medical Laboratories

Risk Management Medical Devices

ISO 14971 - 2013

Risk Management Medical Devices

MAIN STANDARD FOR TESTING AND CALIBRATION LABORATORIES MANAGEMENT SYSTEM

ISO 17025 - 2019

MAIN STANDARD FOR TESTING AND CALIBRATION LABORATORIES MANAGEMENT SYSTEM

Training Program for Hospital

  • ISO AWARENESS TRAINING
  • AWARENESS TRAINING FOR "KALIBRASI"
  • AWARENESS TRAINING FOR "K3L"
  • AWARENESS TRAINING "FINANCE – FINON" PROGRAM
  • LOGISTIC MANAGEMENT TRAINING
  • TRAINING FOR MARKETING
  • LEADERSHIP TRAINING
  • RISK MANAGEMENT TRAINING

Our Training Program Excellences

Modules Completely arranged & in accordance with the needs of the hospital

Trainers are professionals in the health sector

Each training is accompanied by appropriate case studies

An interactive & fun training atmosphere

Equipped with pre-test and post-test evaluations

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Licensing

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