Trusted Medical Device Registration Service
Fast-Track your HSA / MDA Medical Device Approval
From documentation to approval, we streamline every step of the HSA (Singapore) and MDA (Malaysia) medical device registration process. We help you achieve faster, cost-effective compliance without delays
- 22+ Years of Experience
- Tailored Solutions
- Trusted by Healthcare Leaders
Comprehensive Medical Device Registration Services
At Nyprax Pharma, we offer comprehensive support for the registration of medical devices, including:
Registration Dossier Compilation
We prepare and organize complete dossiers for all risk classes of devices and their variants.
Principal & Ministry Liaison
We work closely with your principals/manufacturers and the ministry to ensure swift documentation flow
Document Guidance
Need clarity on local submission requirements? We guide you step-by-step, ensuring no detail is overlooked.
Online Submission
From Medics (Singapore) to MedCast (Malaysia), we handle digital dossier submissions accurately and on time.
HSA (Singapore) Registration Flow
01.
Scope & Classify the Device
- Confirm medical device/IVD status, intended use, and risk class (A–D); identify any Class A (non-sterile) exemptions.
02.
Appoint Local Parties & Obtain Dealer Licences
- Designate Registrant/LAR (we can act as LAR) and identify Importer/Wholesaler.
- Apply on MEDICS for Importer/Wholesaler Licences (GDPMDS required). Manufacturer’s Licence if producing locally.
03.
Choose Evaluation Route & Build Dossier (CSDT)
- Select Full/Abridged/Expedited (C/D)/Immediate (B)/Priority based on prior approvals.
- Compile ASEAN CSDT: Essential Principles, ISO 14971 risk mgmt, V&V/clinical, biocomp/sterility/EMC, ISO 13485, labelling/IFU, prior approvals.
04.
Submit on MEDICS & Secure Approval
- Create listings, upload CSDT, pay fees; manage HSA queries.
- On approval, device is listed on the SMDR; implement local labelling (English; UDI/traceability where applicable).
05.
Commercialise & Maintain Post-Market Compliance
- Import/distribute under valid licences with GDP(MDS) controls.
- Ongoing vigilance (AE reporting), FSCA/recalls, complaint handling, distribution records, and change notifications/variations to HSA.
MDA (Malaysia) Registration Flow
01.
Scope & Classify the Device
- Confirm medical device/IVD status and risk class (A–D) per MDA rules
02.
Appoint Local Parties & Obtain Establishment Licences
- Appoint Authorised Representative (AR) (if foreign manufacturer).
- Identify Importer/Distributor; all relevant parties secure MDA Establishment Licences with GDPMD compliance.
03.
Conformity Assessment & Dossier (CSDT)
- Class B/C/D: Engage an MDA-registered CAB to assess Essential Principles and the ASEAN CSDT; obtain CAB Certificate/Report.
- Class A: Self-declaration/listing (no CAB). Compile full CSDT (device description, EP checklist, ISO 14971 risk, V&V/clinical, ISO 13485 QMS, labelling, prior approvals).
04.
Submit via MeDC@St, Respond, & Obtain Registration
- AR submits application (CSDT + CAB cert for B/C/D; self-declaration for A), pays fees, and manages MDA queries.
- On approval, device is registered (typically 5-year validity).
05.
Commercialise & Maintain Post-Market Compliance
- Import/distribute under GDPMD controls with traceability/storage.
- Ongoing vigilance reporting, FCAs/recalls, complaint handling, change notifications, and timely renewal before expiry.
Why Choose Nyprax Pharma?
Minimizing Costs and Beating Deadlines
We guide in grouping multiple devices under fewer submissions, cutting down on registration fees.
Decades of Expertise
Our seasoned regulatory consultants have worked with a broad spectrum of medical devices—ensuring you get advice that is precise and proven.
Tailored Solutions
Nyprax Pharma excels in providing tailored solutions to address these challenges effectively.
Trusted by Industry Leaders
Our clientele includes top-tier manufacturers who rely on our consistent, high-quality service.
Meet Our Consultants
Kenna Rasiklal
CEO / Managing Director
- Forefront of medical device regulation since 2003
- Strategic planning, product submissions, and quality system implementation
- Holds a Pharmacy degree from the University of Science, Malaysia
- Fluent in English, Malay, Hindi, and Bahasa Indonesia
Bharat Damani
COO / Director
- Quality engineering and Sales / BD background
- Expertise in SOPs, GDPMDS, GDP, and GMP
- Holds an Engineering degree from NUS Singapore
- Fluent in English, Malay, Hindi, and Bahasa Indonesia
Represented Global Leaders in Healthcare
