Malaysia
Definition of medical device
As prescribed in the Medical Device Act 2012, “Tmedical device" means:
(a) any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article intended by the manufacturer to be used, alone or in combination, for human beings for the purpose of—
-
- diagnosis, prevention, monitoring, treatment or alleviation of disease;
- diagnosis, monitoring, treatment, alleviation of, or compensation for an injury;
- investigation, replacement or modification, or support of the anatomy or of a physiological process;
- support or sustaining life;
- control of conception;
- disinfection of medical device; or
- providing information for medical or diagnostic purpose by means of in vitro examination of specimens derived from the human body,
which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but that may be assisted in its intended function by such means; and
(b) any instrument, apparatus, implement, machine, appliance, implant, in-vitro reagent or calibrator, software, material or other similar or related article, to be used on the human body, which the Minister may, after taking into consideration issues of public safety, public health or public risk, declare to be a medical device by order published in the Gazette.Gazette).
Classification
| Type | Risk level |
| A | Low risk |
| B | Low to moderate risk |
| C | Moderate to high risk |
| D | High risk |
Competent Authorities and Registration Process
- Regulatory Authority: Medical Device Authority (MDA), under the Ministry of Health Malaysia.
- n accordance with the Medical Device Act 2012, all medical devices must be registered before being circulated on the market. The registration and submission process is conducted through the Medical Device Centralized Online Application System (MeDC@St2.0+). Only enterprises with a valid Establishment Licence are permitted to submit medical device registration application.
- For Class B, C, and D medical devices, it is required to conduct a conformity assessment by MeDC@St2.0+ All are required to undergo conformity assessment by Conformity Assessment Body (CAB). -Class A medical devices, however, are exempt from conformity assessment.
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 Malaysia 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 Malaysia, 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.