Medical Device Consulting
Our Process
Discover our comprehensive approach to navigating medical device consulting, tailored to ensure your product’s success from start to finish.
Initial Consultation and Assessment
We begin by assessing your medical device’s regulatory needs and market potential, laying the groundwork for a strategic roadmap.
Strategic Implementation
Next, we guide you through regulatory submissions and market entry tactics to streamline commercialization.
Ongoing Support and Optimization
Our team ensures continued compliance and adapts strategies to maintain your product’s success in the evolving medical sector.
Comprehensive Medical Device Consulting Services
Explore our expert consulting offerings, dedicated to ensuring your medical devices meet all regulatory requirements and succeed in the Malaysian market.
Regulatory Compliance Consulting
We guide your product seamlessly through Malaysia’s medical device regulations to secure timely approvals.
What’s included
What’s included
- Medical device classification (Class A, B, C, D)
- MDA registration and renewal management
- Conformity assessment and technical file review
- Post-market surveillance planning
- Regulatory gap analysis and remediation
- Labelling and Instructions for Use (IFU) review
GDPMD Audit & Compliance
Good Distribution Practice for Medical Devices (GDPMD) is a mandatory requirement for licensed importers and distributors in Malaysia. We conduct internal audits to assess your readiness, liaise directly with auditors on your behalf, and develop a customised GDPMD Quality Management System tailored to your company’s operations — ensuring full compliance with MDA’s distribution standards.
What’s included
- Customised GDPMD Quality Management System (QMS) for your company
- Internal GDPMD audit against MDA requirements
- Gap analysis and corrective action planning
- Liaison with GDPMD auditors on your behalf
- Audit preparation and documentation review
- Standard Operating Procedure (SOP) development
- Staff training and awareness support
- Post-audit follow-up and close-out assistance
Local Authorised Representative (LAR)
Manufacturers located outside Malaysia must appoint a Local Authorised Representative (LAR) to sell in Malaysia — a mandatory requirement under Act 737 and the Medical Device Regulations 2012. Innosafe can act as your LAR, register your devices with MDA, hold your product licences, and ensure ongoing compliance with local laws and regulations
What’s included
- Complaints handling and safety notification management
- Act as your official LAR with the Medical Device Authority (MDA)
- MDA product registration and licence holding on your behalf
- Serve as your primary contact point with MDA
- Keep importers and distributors updated on registration certificates
- Post-market surveillance and regulatory intelligence updates
- Adverse event and incident reporting to competent authorities
- Field safety corrective actions and product recall liaison
- Strategic assistance to efficiently launch and sustain your medical device in the local market, maximizing impact and growth.