Corporate culture was described in the preceding discussion as a set of basic beliefs and common practices that serve to define a firm both internally for employees and externally for stakeholders as well as being a part of the organization's public image.

The Program for Increasing the Use of Domestic Products (P3DN) is governed by government regulations, which have changed the rules of the game in the government market segment.

1. Provide chances for businesspeople to launch a company that manufactures and distributes medical products made in the country.

2. Internal regulatory compliance of the business.

3. Educate the budget user work unit on "compliance".

Compliance requires that every action taken by medical device companies in Indonesia fulfill the "legal and ethical" aspects. Legal aspects are made by legislators and/or regulators in the general scope, the contents are recorded in the state newsletter, settlements are made through the court, there are sanctions for deviations in the form of criminal or civil penalties, and physical evidence is required. Ethical aspects are organized based on the consensus of the company, organization, or association. The scope is compelled for the members of the organization or association, the content is written or in the form of oral code, dispute resolution is through the Ethics Council of the organization or association, and there are sanctions for deviations in the form of isolation, which does not require physical evidence.

Medical device companies are divided into 4 quadrants based on legal and ethical considerations, as follows:

1. Legal and ethical

2. Legal and unethical

3. Illegal but ethical

4. Illegal and unethical

The corporation is faced with challenges in quadrants 3 and 4 of the business environment.

Citing several media reports: Indonesia’s Corruption Eradication Commission (KPK) finds 210 corruption cases in the health sector https://nasional.kompas.com/read/2022/10/07/10554731,   Most cases of corruption occur in the private sector. https://www.beritasatu.com/nasional/807239

ICW 2023 Report https://antikorupsi.org/

By Supreme Court Regulation Number 4/2016, Article 4, "corporations can be punished" if:

1. Obtaining profits or benefits from the criminal offense, or the criminal offense was committed for the benefit of the corporation,

2. Directors and commissioners as beneficial owners (Beneficial Ownership-BO) can be punished if they receive benefits from criminal acts and/or,

3. Omitting the occurrence of a criminal offense,

4. Not taking the necessary steps to:

• Take precautions,

• Prevent greater impact,

• Ensure compliance with applicable legal provisions to avoid the occurrence of criminal offenses.

Considering the legal and ethical aspects above, Medical Device companies in Indonesia must continue to build a compliance risk mitigation culture, including;

1. No sales or business advantage is worth compromising the Company's reputation.

2. Protect the Company's assets, directorships, commissionaires, and/or beneficial owners.

3. Build a culture that supports the achievement of the Company's goals (enabler).

In terms of quality management, ISO 37001:2016 can be the answer to the legal and ethical dilemma of the business world. The ISO 37001 Quality Management Standard is an Anti-Bribery Management System designed to help establish, implement, maintain, and improve compliance of anti-bribery programs using a risk-based approach.

 Salam Inspirasi,

Compiled from various sources of Indonesia’s Corruption Eradication Commission (KPK) and Indonesia Corruption Watch (ICW).