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Medical Devices

We offer integrated solutions concerning
regulatory approval, clinical research,
reimbursement approval, market research,
distribution and logistics.

Clinical Research

Overview

A clinical trial of medical devices refers to the process in which the medical institutions qualified from conducting clinical trial of medical devices testing and verifying the safety and efficacy of the medical devices submitted to register in normal condition.

As the first medical device CRO in Korea, Synex could be a reliable partner for manufacturers who are unfamiliar with medical device clinical trials to successfully complete them.

Customer Value

  • A lot of experience in medical device clinical research

    • -Design protocol appropriate to study objectives
    • - Extensive experiences across various medical devices

  • Scientific Design

    • -Selection of reference product thorough investigation of current products and prior research
    • -Establishing hypotheses and developing statistical analysis models through analysis of previous research

  • Fast Study Approval

    • -Meet and educate MFDS reviewers prior to filing study protocols
    • -Proceed IRB approval in parallel

  • Strict Compliance to GCP

    • -Prepare for inspection by regulatory authorities
    • -Monitoring to ensure compliance to GCP

  • Connected to Regulatory Affairs, nHTA and Reimbursement

    • -Designed to meet the requirements about regulatory affairs, nHTA and reimbursement for goal achievement
    • -Developing a strategy that reflects the reimbursed listing status of similar products
Product Approval

Overview

In order for medical devices to enter the market, safety and effectiveness must be evaluated according to the relevant regulations. Medical devices R&D product approval varies greatly in terms of period and cost depending on the strategy, so it is necessary to check the class and classification, intended use and status of the medical device.

Synex provides regulatory services with clear understanding on Ministry of Food and Drug Safety approval standards and efficient communication with agencies based on professional knowledge and experience. Also, we can provide global regulatory affairs with clear understanding on approval standards, requirements and regulations of target countries and efficient communication with local agencies and representatives.

Customer Value

  • Provide information of domestic/ international regulations

    • - Provide guidance and standard guide reflecting each product’s characteristics
    • -Confirmation of test items and minimization of nonconformity through preliminary inspection before a test inspection

  • Set approval goals that abides by the business goal

    • -Exactly categorize the classification
    • -Develop purpose of use according to the business goal

  • Provide credible information

    • - Identify local medical device systems, regulations and follow-up systems using reliable networks
    • -Preemption of global trends

  • Reimbursement process in parallel

    • -Simultaneous process with new Health Technology Assessment (nHTA)
    • -Set up regulatory strategies in conjunction with reimbursement strategies

  • Link with global approval and quality system

    • -Coordinate with ISO 13485, FDA QSR
    • - Integrated strategy from R & D to domestic approval, overseas approval and quality system

  • Fast problem solving

    • -Provide a door-to-door consultation service
    • -Group a task force team when issues occur

  • Communication over clients’ benefit

    • -Act on behalf of clients from pre-consultation to final approval
    • -Active communication with overseas manufacturers and agencies
Quality System

Overview

Good Manufacturing Practice (GMP) stands for a quality management system which provides the matters to be observed in order to guarantee the quality of medical devices throughout the entire process including development , purchasing, manufacturing, inspection, packing, installation, storage, shipment, claim and return so that high quality products can be supplied consistently at all times.

Synex provides a strategic plan to establish a quality system within the shortest time period cost-effectively based on the understanding of the specialized customer requirements.

Customer Value

  • Apply accurate MFDS regulations according to the size of manufacturer

    • -Fast KGMP certification and management according to organization and size
    • -Establish GIP system for importers and GSP system for exporters

  • Minimize costs by quality systems optimization

    • -Implement teamwork system for collaboration between quality department and other departments
    • -Establish and operate a continuous quality system

  • Customer-centered quality systems training

    • -Pre/ post training of quality systems training
    • -Educate and training on global quality standards

  • Establish SOP

    • -Establish SOP according to the size of company and its products
    • -Apply SOP to quality systems

  • Professional communication representing the interests of the customer

    • -Prepare applications for KGMP certifications
    • -English-Korean interpretation during on-site inspection
Reimbursement

Overview

Synex provides professional consultation service with more than 20 years of experience. We minimize conflicts between customers, hospitals and HIRA (Health Insurance Review & Assessment) through effective communication based on objective evidences.

Customer Value

  • Latest information on policy changes

    • -Pioneer new reimbursement opportunities in the pursuit of policy directions
    • -Provide early insights on potential business impacts by reimbursement policy changes

  • Business plan based on reimbursement strategies

    • -Develop reimbursement strategies in conjunction with business plan (reimbursement vs. non-reimbursement decision)
    • -Work out strategies to avoid the rejection of device fee approval

  • New Health Technology Assessment (nHTA)

    • -Determine the status of existing technology vs. new technology · Set up business and reimbursement plans reflecting the result of nHTA
    • -Design evidence development strategies for Limited Health Technology

  • Pricing strategies

    • -Develop rationales for accomplishing target prices and prepare applications supported by evidence
    • - Pre-consultation to achieve target prices

  • Professional communication to the best interest of customer

    • -Close communication with key stakeholders throughout the whole review process
    • -Keep updating customer of the progresses made in the reimbursement agency internally
Market Research

Overview

Our internal and external expertise in multiple disciplines design and offer goal-oriented research method for clients interested in Korean healthcare market.

The internal data of market, such as analysis of competitiveness among products, sales performance or success/failure of products, etc. are gathered through in-depth interviews with professionals such as clinical doctors, medical institutions, business experts and regulatory agencies. Finally, experts of Synex put data together and analyze information properly for the customer’s purpose.

Customer Value

  • Distribution partnership options

    • -Recommend options on distribution models
    • -Search qualified distributor candidates matching customer’s criteria

  • Quantitative research based on national NIH claim data

    • -Process big data from national NIH claim data to customize information for business interest
    • -Analyze and interpret the information to understand market dynamics

  • Qualitative research through wide access to KOLs

    • -Interview doctors, nurses, and technicians to obtain end-user views
    • -Discover requirements of end-users to create business opportunities

  • Reality checks with Korean business experts

    • -Interview business experts of extensive experiences in relevant market segment
    • -Find out lessons from previous success/failure cases

  • Advices on market access strategies

    • -Provide advices on business model, product portfolio, distributorship options, etc.
    • -Suggest reimbursement and regulatory strategies optimized to market entry
ICC Service

Overview

Under In-Country Caretaker service, Synex acts as your total business representative in Korea. Through the ICC Service model, the foreign manufacturers are able to set up a legal entity that has similar characteristics as branch without much initial investment while the distributor is able to concentrate on sales and customers by escaping from the duties such as strict product registration & license management or reimbursement, etc. to lead an even more effective business structure.

Customer Value

  • Faster Market Access

    • -Register products and select distributors in parallel
    • -Set up business models with Synex experts in multiple disciplines

  • Multiple Distribution Partnerships

    • -Work with a multiple number of distributors or sales agents
    • -Flexible to change/expand sales channel without license issue

  • Business Safety

    • -Secure the actual ownership of product license
    • - Product license management with high level compliance

  • Reasonable Fees

    • -Flexible service fee based on business scale, import volume and revenue
    • -Provide various options for logistics fee

  • Perfect Replacement of Your Subsidiary in Korea

    • -No capital investment to set up a legal entity
    • -No need to hire RA/QM/PV manager and supply chain manager
    • -No need to rent office and warehouse space