Indonesia
Definition of medical devices
Medical devices refers to instruments, equipment, machines, and/or implantable devices that do not contain medicinal substances, used for the prevention, diagnosis, treatment, and alleviation of diseases, treatment of patients, restoration of human health, and/or construction and improvement of body structure and functions. (Article 1.1 Permenkes Number 1189)
Classification
| Type | Risk level |
| I | Low risk |
| II | Low to moderate risk |
| III | Moderate to high risk |
| IV | High risk |
Competent Authorities and Registration Process
- Registrasi Alat Kesehatan & PKRT Online
- Registration process
| Fertilizer Classification | Evaluation time (days) | Timeline licensing period | Timeline additional time (days) | Fight second price | Timeline |
| A | 10 | Within 10 days from the date the evaluation is completed | 10 | Within 10 days from the date of receipt of the complete application | Within 10 days from the date the evaluation is completed |
| B | 20 | 10 | |||
| C | 20 | 10 | |||
| D | 30 | 15 |
Options for registration applicant
Our Services
Registration service
Registration service
With a team of experts deeply knowledgeable in local regulatory requirements and extensive hands-on experience in medical device registration, MedNovum is willing to accompanie enterprises through every step — from document preparation to achieving results — ensuring a registration process that is accurate, efficient, and timely.
Marketing Authorization Holder (MAH) Service
Marketing Authorization Holder (MAH) Service
If enterprises are concerned about the cost of establishing a legal entity in Indonesia or wish to avoid granting exclusive distribution rights to a local partner, MedNovum offers a flexible and optimal solution. Through our trusted partner based in Indonesia, we provide MAH service, supporting enterprises in submitting registration applications as designated, while helping them maintain control over product management and market.
Regulatory Compliance Consulting Service
Regulatory Compliance Consulting Service
-Language barriers and the complexity of local regulations often pose challenges for enterprises entering new markets. Don’t worry — with MedNovum’s specialized consulting services, we ensure your compliance from the initial market entry stage through post-market activities.
MEDNOVUM
YOUR COMPREHENSIVE PARTNER IN THE MEDICAL DEVICES SECTOR
HUMAN RESOURCES
MedNovum brings together a team of experienced experts, including lawyers, pharmacists, and engineers who are extensively trained in the field of medical devices. With a strong knowledge base and deep understanding of legal regulations, technical procedures, and market requirements across multiple countries, we are confident in delivering comprehensive, accurate, and effective service solutions to every client. The combination of legal expertise and technical proficiency is what sets MedNovum apart, making us a trusted partner for many years.
ISO CERTIFICATE
Achieving the ISO 9001:2015 certification is an important milestone in MedNovum’s development journey. This achievement shows our strong commitment to maintaining high-quality services, meeting customer expectations, and strengthening MedNovum’s position in the medical device market.
NUMBER OF YEARS OF EXPERIENCE
With over 10 years of experience in the medical device industry, we understand the needs and challenges that businesses face. MedNovum is committed to providing professional, accurate, and reliable services – helping our clients save time, ensure regulatory compliance, and improve business performance.