SNQ Quality Mark

SNQ is built on evidence-based standards, setting trusted quality and safety benchmarks for healthcare, biomedical, health, and animal care services and products.

  • 9F, No. 508, Sec. 7, Zhongxiao E. Rd., Nangang Dist., Taipei City, Taiwan
  • +886 2 2655 7888
  • snq@snq.com.tw

About the National Quality Mark

  • Vision & Mission
  • Review Committee
  • Certification Schedule

Certification Methods

  • Medical Service
  • Biomedical Product
  • Health Product
  • Animal Care & Products

SNQ Certified

  • Certified Services & Products
  • Certified Organizations
  • Quality Award Winners

International Certification

  • ICHOM PROMs
  • NSF Certification

Quality Focus

  • Apply for Certification →
Organized by|Research Center for Biotechnology and Medicine PolicyOperated by|Kuanglu International Quality Standards Co., Ltd.© 2026 Kuanglu International Quality Standards Co., Ltd. All rights reserved.Privacy Policy
SNQ Quality Mark
繁中
/
EN

Medical & Healthcare Devices

Recognizing products that excel across medical equipment, reagents and consumables, health promotion, and rehabilitation aids.

Application Regulations

Scope of Application

Applications must be submitted by a single institution for one service, technology, process, project or product.

Regulatory Compliance

Applications must comply with all relevant laws and regulations, and shall not involve false claims, infringement, counterfeiting, or violations of intellectual property rights.

Application Documents

All submitted documents and supporting reports must be true and accurate. Any falsification or misrepresentation will lead to disqualification or termination of certification, a three-year prohibition on re-application, and full legal liability borne by the applicant.

Data Handling

The certification body and review committee are obliged to maintain confidentiality of application materials. However, all submitted documents, attachments, and physical products will not be returned, regardless of review outcome.

Refund Policy

Once the review process has commenced, application fees are non-refundable, regardless of withdrawal or disqualification.

Mark Authorization

Certified items, upon receipt of official notification, are required to sign the "SNQ License Agreement" before being formally authorized to use the SNQ Mark and its related identifiers.

  1. Home
  2. Application
  3. Medical & Healthcare Devices

Overview

What is Evaluated:

Quality control and safety standards, manufacturing process audits, product efficacy, innovation, and market influence.

Who Can Apply:

Registered enterprises and institutions (including manufacturers, importers, and agents).

Why It Matters:

Strengthen consumer trust, ensure compliance with medical device regulations, promote technological innovation, and expand domestic and international market influence.

Subcategories & Criteria

Eligibility:Products with valid medical device licenses that provide medical, diagnostic, testing, or health-related functions, including equipment, instruments, devices, and software. (For regulated medical devices, applicants must submit proof of registration and licenses issued by the Ministry of Health and Welfare.)
Evaluation Criteria & Weighting:
  1. Company Operation (10%)
  2. Review basic corporate information including company name, establishment date, person in charge of the company, capital, business scope, etc.
    Assess company vision, management team, workforce, organizational quality system, current business operations and overall organizational performance.
    Evaluate market strategy, positioning, scale of operations, sales achievements, market share, and competitiveness.
    Review social recognition and contributions to public welfare initiatives.
  3. Product Features (20%)
  4. Review product design concepts and hardware/software architecture.
    Evaluate hardware equipment, software UI/UX and operating systems.
    Evaluate intended use, functional scope, and application contexts.
    - Class I (Low Risk)
    Devices with minimal potential for harm to the user. Typically non-invasive and simple in design.
    - Class II (Moderate Risk)
    Devices that present a higher degree of risk and require stricter regulatory controls. These may involve short-term invasive use or active monitoring functions.
    - Class III (High Risk)
    Devices that sustain or support life, are implanted, or present a significant risk of illness or injury. These require the highest level of regulatory oversight, including clinical evidence and comprehensive safety validation.
    Applicants should provide:
    - Official classification documentation issued by the regulatory authority.
    - Supporting evidence such as product registration certificates, risk assessment reports, and compliance with ISO 13485 or equivalent standards.
    Analyze product differentiation and unique features compared to domestic and international competitors.
    Review patent types, application countries, and acquisition status.
  5. Application Impact (20%)
  6. Explain benefits for target users or groups.
    Provide objective data supporting service outcomes or effectiveness.
    Evaluate domestic and international market positioning, advantages, and differentiation.
    Review current or projected market scale and growth potential.
    Include satisfaction levels regarding hardware, software, and service models.
  7. Quality Management (25%)
  8. Outline design and development standards, risk control measures, and validation processes; include software lifecycle management and maintenance procedures.
    a. Provide details on production and quality control processes, yield rates, and submit factory registration certificates and compliance documents (e.g., ISO, GMP/QMS certificates).
    b. QC Flow Chart: Applicants must provide detailed flow charts that illustrate:
    - Raw material sourcing
    - Production stages
    c. Segmented Manufacturing Requirement (if applicable)
    - If manufacturing is divided into multiple stages or segments, applicants must submit one of the following:
    - Option 1: QC flow chart for each individual stage.
    - Option 2: Joint audit documents that serve as supporting evidence of QC across all stages.
    a. Review raw material, semi-finished, and finished product standards, supplier audits, verification methods, acceptance processes, and third-party certifications.
    b. Assess software functionality testing and third-party validation.
    c. Confirm compliance with raw material acceptance standards and safety testing.
    Evaluate risk assessment mechanisms and abnormal/potential risk management procedures.
    Describe principles, structure, and procedures for handling emergencies.
    Confirm compliance with ISO 13485, ISO 9001/ISO 14001/ISO 45001, IEC, CE, EN, etc.
  9. Safety (25%)
  10. Provide product labeling and basic instructions; include user manuals as attachments.
    Explain standard monitoring procedures and provide supporting records such as observation logs, complaint analysis, and customer service reports.
    Provide records of violations within the past three years (if none, state "None").

Application Timeline

Online Application
May – August
As announced in the annual call for entries
Document Submission
End of August
Submit all required documents by the deadline
Review & Evaluation
September - November
Includes administrative review, document review, presentation review, and the final review committee meeting.
Announcement of Certification Results
December
Certification results determined and certified institutions are required to sign the "SNQ Mark License Agreement," valid for one year.
Renewal Application
Next July – September
Renewal application with required documents must be submitted within three months before certification expiry. Renewal applicants may also apply for the National Biotechnology & Medical Care Quality Award in the same application cycle.

Application Documents

Applies to|Pharmaceuticals, Traditional Chinese Medicines, Medical & Healthcare Devices, Clinical Support Services & Products, Smart Health Technology, Aging Health & Long-Term Care, Nutritional Health, Cosmetics, Epidemic Prevention Products, and Animal Care Services & Products categories

Application Steps

  1. 1
    Online Application

    All applications must be submitted online. Visit the SNQ official website (www.snq.org.tw) homepage and then click "Apply for Certification".

  2. 2
    Fill in the Form and Download Templates

    Log in to the "Application & Review Data Maintenance Portal" to complete the application form and download the required document templates.

  3. 3
    Pay the Fees and Upload Materials

    Pay the application fees and upload the required materials as specified. The application is considered complete only after the organizer confirms receipt.

Required Materials

  1. 1
    Application Consent Form

    Complete the online application form, print it, affix the institution's official and small seals, then scan and upload the signed copy as a PDF.

  2. 2
    Application Plan

    Prepare the plan per each category's template and upload as an unencrypted PDF. (Content must be complete and include supporting evidence.)

  3. 3
    Application Item Images

    (1) 3–5 photos (jpg or png, at least 1000 × 750px in 4:3 landscape, 300dpi or higher). Product entries must include a background-removed hero photo, centred and scaled so the product is fully visible with no part of it clipped by any edge; other close-up shots are exempt from this rule. Technology or service entries should show the theme, workflow, features, and team; nutritional health products additionally require close-ups of the packaging and labelling. (2) Applicant logo (jpg or png, 300dpi or higher).

  4. 4
    Product Samples (10 units)

    Provide 10 samples with complete inner and outer packaging identical to what is sold on the market; if multiple specifications exist, submit 10 of each. Deliver in person or by registered mail to "1F, No. 508, Sec. 7, Zhongxiao E. Rd., Nangang Dist., Taipei 115 - SNQ National Quality Mark Administrative Team". (Skip if no physical product exists; for oversized products, contact the coordinator to confirm the arrangement.)

Application Fees

Products
NT$ 100,000/ per item

Pharmaceuticals, Traditional Chinese Medicines, Medical & Healthcare Devices, Clinical Support Services & Products, Smart Health Technology, Aging Health & Long-Term Care, Nutritional Health, Cosmetics, Epidemic Prevention Products, and Animal Care Services & Products categories.

  • Applications that do not pass review (including ineligibility or failure at any stage, excluding revisions) will receive a refund within 30 days of the result announcement, after deducting NT$ 30,000 for administrative and review fees. Nutritional health products run in two application rounds; entries rejected in the first round may reapply for the second round after improvements, to encourage quality improvement.

  • Series product bundle applications are priced at NT$ 120,000 for two items, plus NT$ 20,000 for each additional item. Failed applications are refunded after deducting NT$ 30,000 for administrative and review fees.

Bundled Applications

Applicants may bundle multiple items submitted in the same year (same round) into a single application if the following conditions are met. A bundled application must submit one integrated plan covering the series (including each product's ingredient specification and related test reports).

Medical and Healthcare Devices

The main structural components, efficacy claims, and intended use are the same; the products must be produced by the same manufacturer using the same manufacturing process and have the same medical device licence number.

Bundled applications submit a single plan; the fees are NT$ 120,000 for two items plus NT$ 20,000 for each additional item. Approved bundles share a single SNQ National Quality Mark certificate and authorization agreement; failed applications are refunded after deducting NT$ 30,000 for administrative and review fees. Annual renewal costs NT$ 20,000 per item. (Whether items qualify as a product series is determined at the organizer's discretion.)

Review Process

1
Administrative Review
Verify eligibility, category, and completeness of submitted materials.
2
Document Review
Reviewers assess applications based on defined criteria; comments provided for applicant response.
3
Presentation Review
Review committee presentation meeting and Q&A; scoring by criteria and weightings; results determine shortlist for site visits.
4
Final Review & Resolution
Committee finalizes certification results and determine winners of the National Biotechnology & Medical Care Quality Award

Review & Authorization

Result Notification & Mark Authorization

The organizer notifies applicants of the review results by formal written letter each December and publishes the selected list on the SNQ official website. Each selected unit must sign the "SNQ National Quality Mark Usage Authorization Agreement" with the organizer before the selected item may officially use the "SNQ National Quality Mark".

Sampling & Audits

  • After the announcement, the organizer randomly inspects the quality and mark usage of selected items through market channels; any violation of authority regulations or significant quality defect will result in revoked mark authorization, with full legal responsibility borne by the applicant.

  • The organizer conducts unscheduled on-site visits or paper reviews of manufacturing facilities; for factories located overseas, alternative measures beyond on-site visits are defined.

Renewal

Application Timeline

To ensure certified items maintain their quality, the annual renewal process begins each July. Applicants must submit renewal applications with all required documents at least three months prior to certification expiry.

Validity of Renewal

Approved renewals extend the authorization to use the SNQ Mark and allow continued participation in related promotional programs. The renewed authorization period is from January 1 to December 31 of the following year.

Eligibility for the National Biotechnology & Medical Care Quality Award

Renewal applicants may also apply for the current year's National Biotechnology & Medical Care Quality Award in accordance with that year's application procedures.

Failure to Renew

Applicants who fail to submit a renewal application within the specified timeframe will lose authorization to use the SNQ Mark upon expiry and will not be eligible for further renewal.

Application Fees

The renewal administrative and review fees are NT$ 20,000. Applicants who also enter the current year's National Biotechnology & Medical Care Quality Award pay NT$ 30,000. (No additional refund is given if the renewal or award bid is unsuccessful.)