Singapore
Definition of medical devices
According to the provisions of the First Schedule of the Health Products Act 2007, “Medical devices” means:
(a) là bất kỳ dụng cụ, thiết bị, công cụ, máy móc, vật dụng, vật cấy ghép, thuốc thử dùng trong xét nghiệm in vitro, phần mềm, vật liệu hoặc các sản phẩm tương tự hoặc có liên quan khác được nhà sản xuất chỉ định sử dụng, dù riêng lẻ hay kết hợp, cho con người nhằm một hoặc nhiều mục đích cụ thể sau đây:
- diagnosis, prevention, monitoring, treatment or alleviation of disease;
- diagnosis, monitoring, treatment or alleviation of, or compensation for, an injury;
- investigation, replacement, modification or support of the anatomy or of a physiological process, mainly for medical purposes;
- support or sustaining life;
- control of conception;
- disinfection of medical devices; or
- providing information by means of in-vitro examination of specimens derived from the human body, for medical or diagnostic purposes,
and which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its intended function by such means, and which is not a cell, tissue or gene therapy product; and
(b) bao gồm các vật phẩm sau:
- any implant for the modification or fixation of any body part;
- any injectable dermal filler or mucous membrane filler;
- any instrument, apparatus, implement, machine or appliance intended to be used for the removal or degradation of fat by invasive means.
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: The Health Sciences Authority (HSA)
- The registration and application submission process is carried out through the Singapore Health Product Access and Regulatory E‑System (SHARE). To obtain a dealer’s licence and perform medical devices registration, enterprises must first be registered with the Accounting and Corporate Regulatory Authority (ACRA) and subsequently create a Client Registration and Identification Service (CRIS) with HSA.
- The Registration Pathway:
For Class A medical devices, the registration process is not required. However, the manufacturer or distributor shall submit a notification to the HSA listing the medical devices to be circulated on the market, and must fully comply with other applicable regulatory requirements such as dealer licensing and related obligations.
For Class B, C, and D medical devices, the registration process prior to circulation is mandatory, with the following registration routes available:
- Class B: There are 3 registration routes – Full, Abridged, and Immediate.
- Class C There are 4 registered routes – ull, Abridged, Expedited, and Immediate..
- Class D: There are 3 registration routes – Full, Abridged, and Expedited..
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 Singapore 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 Singapore, 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.