Based on the Annex to the Regulation of the Minister of Health Number 14 of 2021 concerning Standards for Business Activities and Products in the Implementation of Risk-Based Business Licensing in the Health Sector ("Permenkes No. 14/2021"), Medical Devices are instruments, apparatuses, machines and/or implants that do not contain drugs used to prevent, diagnose, cure and alleviate diseases, treat sick people, restore health in humans, and/or form structures and improve body functions. Medical Devices are also in vitro reagents and calibrators, software, materials or materials used singly or in combination, to block fertilization, disinfection of medical devices, and in vitro testing of specimens from the human body, and may contain drugs that do not achieve the main work in the human body through pharmacological, immunological, or metabolic processes to be able to help the desired function or work.

While what is meant by In Vitro Diagnostic Medical Devices is any reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment or system, whether used alone or in combination with other reagents, reagent products, calibrators, control materials, kits, instruments, apparatus, equipment or systems that are expected by the product owner to be used in vitro for examination of each specimen, including blood or tissue donors originating in the human body, solely or essentially for the purpose of providing information with due regard to physiological or pathological states or congenital abnormalities, to determine the safety and suitability of any blood or tissue donor with potential recipients, or to monitor the size of the therapy and house the specimen. When viewed from the risks arising from the misinterpretation of the examination results for individuals and the community, In Vitro Diagnostic Medical Devices can be divided into:

• Class A In Vitro Diagnostic Medical Devices pose a low risk to individuals and society;
• Class B In Vitro Diagnostic Medical Devices pose a moderate risk to the individual and a low risk to society;
• Class C In Vitro Diagnostic Medical Devices pose a high risk to the individual and a moderate risk to society; and
• In Vitro Diagnostic Medical Devices class D poses a high risk to individuals and society.

Every Medical Device Distributor who wants to distribute medical devices must have:

• Distribution Permit, namely permission for Medical Devices, In Vitro Diagnostic Medical Devices and PKRT produced by Manufacturers, and/or imported by Distributors of Medical Devices and In Vitro Diagnostic Medical Devices or importers to be circulated in the territory of the Republic of Indonesia, based on an assessment of safety, quality, and expediency; and
• Medical Device Distribution Permit or DAK Permit, which is a permit granted to a Medical Device Distributor to carry out a series of distribution activities or delivery of Medical Devices.

Only companies in the form of legal entities in the form of Limited Liability Companies or Cooperatives that have permission for the procurement, storage, and distribution of Medical Devices and In Vitro Diagnostic Medical Devices can be referred to as Distributors of Medical Devices.
To apply for a New Permit for Distribution of Domestic In Vitro Diagnostic Medical Devices Class A, B, C, and D, each Medical Device Distributor must meet several general requirements, namely:

1. Letter of cooperation agreement between the product owner and the manufacturer / distributor that has been notarized with a minimum validity period of 2 (two) years, if the product is registered by the product owner or distributor appointed by the manufacturer.
2. Affidavit of Willingness to Release the Agency which is sufficiently sealed;
3. A valid Brand Certificate;
4. Statement of Authenticity Documents that are sufficiently sealed;
5. Integrity Pact in order to prevent corruption, collusion and nepotism with sufficient seals;
6. Proof of payment of Non-Tax State Revenue (PNBP). It should be noted that the PNBP fee that has been paid is non-refundable; and
7. Standard Operating Procedure (SOP) or Fixed Procedure (Protap) and recording system regarding handling customer complaints (complaint handling), unwanted events, product recall and other product information related to post market for new applications.

In addition to the above requirements, there are special requirements that need to be met, namely:

Quality Management System document with the following conditions:

• SNI ISO 9001/ISO 9001 and/or SNI ISO 13485/ISO 13485 follow the latest year issued by nationally and internationally accredited certification bodies, include the name and address of the manufacturer according to the production certificate, still valid with the scope of covering the type of medical device registered.
• CE certificate if it lists a numbered CE on the marking.
• Certificate of How to Make Good Medical Devices (CPAKB) issued by the Ministry of Health if you already have one.

2. Declaration of Conformity or statement of conformity of standards from manufacturers is a document stating the conformity of medical devices registered to the standards of medical devices used in the manufacture of medical devices and copies of the standard manuscripts, such as: SNI products, iso products, pharmacopoeia, and others;

3. Product Information which includes:

• Description of medical devices;
• Description and features of the medical device;
• Purpose of use;
• Indications;
• Instructions for use;
• Counter indications;
• Warning;
• Attention;
• Potential for undesirable effects;
• Alternative therapies;
• Materials / raw materials;
• Factory information; and
• Production process.

4. Specifications and Quality Assurance; and
Marking Requirements.

Specifically for the issuance of a Distribution Permit for Domestic In Vitro Diagnostic Medical Devices with high risk, a Conformity Assessment was carried out by the Ministry of Health. The Conformity Assessment in question includes:

• General/administrative requirements; and
• Special/technical requirements.

The conformity assessment mechanism for the distribution permit of domestic in vitro diagnostic medical devices class A, B, C, and D is carried out by evaluating the suitability of documents uploaded on the medical device registration electronic system integrated with the OSS system.
The criteria, procedures and conditions for applying for extension, change, and extension with changes in the distribution permit for domestic in vitro diagnostic medical devices refer to the Regulation of the Minister of Health Number 26 of 2018 concerning Electronically Integrated Business Licensing Services in the Health Sector ("Permenkes No. 26/2018").
During the COVID-19 pandemic, the types of medical devices that require a Distribution Permit and have been given an acceleration of licensing services by the Ministry of Health through the One Day Service mechanism, consist of:

• Surgical Face Mask;
• Masker N95;
• Isolation gown/Alat Pelindung Diri;
• Liquid Chemical Sterilants/High Level Disinfectants (Disinfektan);
• Surgeon’s Glove (Sarung Tangan Steril);
• Patient Examination Glove (Sarung Tangan Pemeriksaan);
• Clinical Electronic Thermometer;
• Ventilator;
• Infusion Pump;
• Mobile X-Ray;
• High Flow Oxygen Device;
• Bronchoscopy Portable;
• Power Air Purifying Respirator;
• CPAP Mask;
• CPAP Machine;
• ECMO (Extracorporeal Membrane Oxygenation);
• Breathing Circuit for Ventilator and CPAP;
• Neonatal Incubator and Incubator Transport;
• Transport Culture Medium (VTM/UTM);
• Microbiological Specimen Collection and Transport Device (Dacron Swab);
• Alat/Instrument Reagen Rapid Test untuk Pemeriksaan COVID-19;
• Resuscitation Bag; dan
• Hand Sanitizer dan Disinfektan;

Electronic Licensing Services

Business actors who already have NIB and fulfill commitments in accordance with the provisions of laws and regulations regarding electronically integrated licensing services, must fulfill the Commitment to Distribute Medical Devices no later than 14 (fourteen) calendar days. Commitment fulfillment documents are delivered through regalkes.kemkes.go.id integrated with the OSS system. Then, the Ministry of Health evaluates the fulfillment of commitments submitted by business actors (Article 71 paragraphs (1)-(4) of Permenkes 26/2018).
If the medical device uses technology, new active substances and/or with unusual claims, then the evaluation must get consideration from a team of experts determined by the Ministry of Health. The expert team in question consists of elements of related agencies, practitioners, universities, professional organizations and / or associations of business actors (Article 71 paragraph (5)-(6) of permenkes 26/2018).
Evaluation of the fulfillment of the Medical Device Distribution Permit Commitment as referred to in paragraph (4) is carried out for class A Medical Devices no later than 10 (ten) calendar days, class B and class C no later than 20 (twenty) calendar days, and Class D no longer than 30 (thirty) calendar days (Article 71 paragraph (7) of Permenkes 26/2018).
If the results of the evaluation state that there is no improvement, the Ministry of Health will notify the fulfillment of the Commitment to Distribute Medical Devices no later than 5 (five) calendar days through the OSS system. The notification means that the Commitment to Distribution Permit for Medical Devices has been fulfilled (Article 71 paragraph (8) and Article 71 paragraph (13) of permenkes 26/2018).

Cost
Business Licensing may be charged in accordance with the provisions of laws and regulations. The fee must be paid by the Business Actor at the time of submission of the commitment fulfillment document and proof of payment uploaded into the OSS system. If the payment obligation is not carried out, the permit that has been given is declared void (Article 85 paragraph (1)-(5) of permenkes 26/2018).

Validity Period and Extension of Medical Device Distribution Permit
The Medical Device Distribution Permit is valid as long as business actors carry out their business and/or activities (Article 86 paragraph (1) of Permenkes 26/2018) and must be extended no earlier than 9 (nine) months before the validity period ends (Article 87 paragraph (3) of Permenkes 26/2018).

Supervision of the Implementation of Business Licensing

Supervision over the implementation of business permits is carried out by the Minister, Governor, and/or Regent/Mayor. Such oversight begins from the date of the Commitment statement stated in the OSS. If a discrepancy or deviation is found in the implementation of business licensing, the minister, governor, and/or regent/mayor can take actions submitted through the OSS system in the form of (Article 88 paragraph (1)-(8) of Permenkes 26/2018):

• warnings;
• notification of cancellation of business licenses;
• temporary cessation of business activities;
• imposition of administrative fines; and/or
• revocation of The Business License.

Source:

• Regulation of the Minister of Health Number 14 of 2021 concerning Standards for Business Activities and Products in the Implementation of Risk-Based Business Licensing in the Health Sector.
• Regulation of the Minister of Health Number 26 of 2018 concerning Electronically Integrated Business Licensing Services in the Health Sector.
• The Ministry of Health, "Relaxation Flow for the Acceleration of Licensing of Medical Devices and PKRT for Domestic Products in Supporting Covid-19 Mitigation", www.regalkes.kemkes.go.id
• Harsono, Fitri Haryanti, "List of 23 Medical Devices for COVID-19 Obtaining Rapid Distribution Permits from the Ministry of Health", https://m.liputan6.com/health/read/4317445/daftar-23-alat-kesehatan-untuk-covid-19-peroleh-izin-edar-cepat-dari-kemenkes