Introduction
The distribution permit (izin edar) for medical devices is a mandatory requirement before any medical product can be marketed in Indonesia. Its purpose is to ensure the safety, quality, and efficacy of the device for public use. Government Regulation No.72 of 1998 on the Safety of Pharmaceutical Preparations and Medical Devices stipulates that “pharmaceutical preparations and medical devices can only be distributed after obtaining a distribution permit from the Minister” . In line with this, Ministry of Health Regulation No. 62 of 2017 further explains that distribution permits are issued to ensure that medical devices meet safety, quality, and efficacy standards before being used by the public . Compliance with these regulations is crucial to protect patients from the risks of using untested medical devices.
Regulations Regarding Medical Device Distribution Permits
Several official regulations govern medical device licensing in Indonesia. Besides the overarching Health Law No. 36/2009, specific provisions for distribution permits are detailed in Government Regulation 72/1998 and various Ministry of Health Regulations (Permenkes). For example, Article 9 of Government Regulation 72/1998 mandates distribution permits for all medical devices. Furthermore, Ministry of Health Regulation No. 62/2017 (which replaced Ministry Regulation No. 1190/2010) outlines procedures and classifications for medical devices requiring permits. This regulation categorizes devices by risk and function to facilitate supervision. Based on these legal frameworks, every manufacturer or importer must obtain a distribution permit before marketing their products.
15 Types of Medical Devices Requiring Distribution Permits
1. Clinical Laboratory Equipment
Explanation: This category includes devices used in laboratory analyses such as clinical chemistry testing systems, hematology analyzers, immunology, and toxicology instruments. Laboratory results (e.g., blood sugar levels, blood cell counts, hormone levels) are critical for treatment decisions. Inaccurate devices can be fatal.
Examples: Automatic hematology analyzers, clinical chemistry analyzers, laboratory microscopes.
Permit Requirement: According to MOH Regulation 62/2017, “Automatic and Semi-Automatic Hematology Equipment” must have distribution permits. Permits ensure these devices are accurate and safe for diagnostic use.
2. Anesthesia Equipment
Explanation: Devices that assist in administering anesthesia and monitoring patients during medical procedures. They manage oxygen and anesthetic gas delivery and monitor vital signs. Equipment failure here can be life-threatening.
Examples: Ventilators, anesthesia machines, anesthesia monitors.
Permit Requirement: High-risk devices like these must have distribution permits to ensure gas delivery systems and monitors meet medical safety standards.
3. Cardiology Equipment
Explanation: Devices used to diagnose, monitor, and treat heart and vascular diseases. Errors in cardiology devices directly endanger patients’ lives.
Examples: ECG machines, defibrillators, stents, invasive blood pressure monitors.
Permit Requirement: Given their critical function, cardiology devices require permits to guarantee reliability and effectiveness.
4. Dental Equipment
Explanation: Devices used in dental practice for diagnosis, prevention, and treatment of oral and dental problems. If poorly manufactured, these can cause infection or injury.
Examples: Dental drills, dental chairs, dental X-ray machines.
Permit Requirement: Permits ensure sterilization, electrical safety, and, for X-rays, radiation protection standards are met.
5. Ear, Nose, and Throat (ENT) Equipment
Explanation: Devices for diagnosing and treating ENT diseases. Accurate instruments are crucial to avoid complications.
Examples: Otoscopes, audiometers, ENT endoscopy devices.
Permit Requirement: Distribution permits ensure ENT devices are safe, effective, and sterile.
6. Gastroenterology and Urology Equipment
Explanation: Devices used for diagnosing and treating digestive and urinary tract conditions, which are prone to infection or injury.
Examples: Colonoscopes, gastroscopes, urinary catheters.
Permit Requirement: Permits ensure proper sterilization and functionality to prevent infections or complications.
7. Neurology Equipment
Explanation: Devices for diagnosing and treating nervous system disorders. Accurate results are crucial for proper treatment.
Examples: EEG machines, EMG machines, Transcranial Magnetic Stimulation (TMS) devices.
Permit Requirement: Distribution permits ensure neurological devices meet electrical safety and measurement accuracy standards.
8. Obstetrics and Gynecology Equipment
Explanation: Devices used for reproductive health and pregnancy care. High safety standards are essential to protect both mother and baby.
Examples: Pregnancy ultrasound machines, intrauterine catheters (IUDs), fetal heart rate monitors.
Permit Requirement: Permits guarantee the safe use of ultrasound and other reproductive health devices.
9. Ophthalmology (Eye) Equipment
Explanation: Devices for diagnosing and treating eye disorders. Given the sensitivity of the eyes, these devices require high precision.
Examples: Slit lamp microscopes, LASIK surgery machines, intraocular lens implants.
Permit Requirement: Permits ensure that ophthalmic devices are safe for use on delicate eye tissues.
10. Orthopedic and Rehabilitation Equipment
Explanation: Devices related to the musculoskeletal system and rehabilitation of physical functions.
Examples: Orthopedic implants (screws/plates), joint prostheses (knee/hip), ultrasonic physiotherapy devices.
Permit Requirement: Permits guarantee safe implant materials and designs to avoid breakage or inflammation.
11. Physical Therapy and Rehabilitation Devices
Explanation: Equipment used for physical therapy and functional recovery.
Examples: Shockwave therapy devices, electric muscle stimulators (EMS/TENS), rehabilitation treadmills.
Permit Requirement: Permits ensure that therapeutic devices operate safely and effectively.
12. Radiology Equipment
Explanation: Imaging devices using radiation or magnetic fields for internal diagnosis. Due to radiation exposure, strict regulation is necessary.
Examples: Diagnostic X-ray machines, CT scanners, MRI machines.
Permit Requirement: Permits ensure radiation output remains within safe limits and imaging devices meet performance standards.
13. Surgical Equipment (General and Plastic Surgery)
Explanation: Tools used during surgery, where quality and sterility are critical due to invasive procedures.
Examples: Scalpels, operating tables, surgical monitors, suction devices.
Permit Requirement: Surgical instruments must be properly sterilized and meet material standards to prevent infections.
14. General Hospital and Personal Care Equipment
Explanation: General hospital equipment and personal care devices essential for daily healthcare operations.
Examples: Electric hospital beds, infusion pumps, portable ventilators, portable defibrillators, multiparameter patient monitors.
Permit Requirement: Permits ensure stable and safe operation of monitoring and therapeutic devices.
15. In Vitro Diagnostic Medical Devices
Explanation: Although often kits or reagents, they are classified as “medical devices” because they aid diagnosis outside the patient’s body.
Examples: Rapid diagnostic tests, blood glucose test kits, pregnancy test kits (HCG), PCR testing kits.
Permit Requirement: Permits ensure that in vitro diagnostic devices are clinically validated and produce reliable results.
Conclusion
Compliance with medical device marketing authorization regulations is crucial for patient safety. Various types of medical devices – ranging from laboratory equipment to surgical and diagnostic tools – must undergo a marketing authorization process to ensure their standards are guaranteed.
