SS 620 Implementation Guide for Importers and Wholesalers

1. Introduction to SS 620 Implementation Guide

This guide summarises the key requirements for importers and wholesalers implementing a Quality Management System (QMS) aligned with Singapore Standard SS 620:2016 – Good Distribution Practice for Medical Devices. SS 620 Implementation Guide applies to all organisations that import, store, and supply by wholesale medical devices in Singapore. The objective is to ensure the quality, safety, and integrity of medical devices throughout the distribution lifecycle.

SS 620 Standard Key Requirements

Phase 1. Quality Management System Foundation

2. Quality Management System (Clause 4)

The organisation must establish, document, implement, and maintain an effective QMS.

2.1 Documentation Requirements (4.2)

Required documents include:

• Site Master File (SMF)

• Documented procedures

• Records required by SS 620

• Additional documentation required by regulatory authorities

  
  

2.2 Site Master File (4.2.2)

The SMF must describe:

• Scope of SS 620 implementation

• Documented procedures

• Information on premises and activities

  
  

2.3 Control of Documents (4.2.3)

The organisation must:

• Establish document control procedures

• Ensure documents are approved, current, and periodically reviewed

• Prevent unintended use of superseded versions

  
  

2.4 Control of Records (4.2.4)

Records must be:

• Legible, identifiable, and retrievable

• Retained for at least the projected useful life of the medical device

• Retained for not less than 2 years from the supply date

  
  

3. Management Responsibility (Clause 5)

3.1 Management Representative (5.2)

The organisation must:

• Appoint one management representative (with optional deputy)

• Ensure QMS establishment, implementation, and maintenance

• Report QMS performance

• Promote awareness of regulatory and customer requirements

  
  

3.2 Management Review (5.3)

Top management must conduct reviews:

• At planned intervals

• At least once per year

  Review inputs include:

• Internal audit results

• Customer feedback

• Status of corrective actions and FSCA

• Updates to regulatory requirements

  
  

4. Resource Management (Clause 6)

4.1 Personnel (6.1)

Personnel must be competent based on:

• Education

• Training

• Skills

• Experience

4.2 Training (6.2)

The organisation must:

• Identify required competencies for each role

• Provide necessary training

• Evaluate training effectiveness

• Maintain training records for the duration of employment

• Provide specialised training for cold-chain, biological, or chemical handling where needed

Phase 2. Operational Requirements

5. Premises and Facilities (Clause 7)

5.1 Receipt of Stock (7.1.1)

Requirements include:

• Verification to ensure devices meet specified requirements

• Immediate identification of special-storage devices

• Protection of incoming deliveries from rain or damage

• Separation of receiving areas from general storage

5.2 Storage Conditions (7.1.2)

The organisation must:

• Prevent deterioration (temperature, light, moisture)

• Monitor and record storage conditions

• Provide equipment for special conditions (e.g., ≤8°C cold chain)

5.3 Segregation (7.1.2)

Separate zones must exist for:

• Quarantined stock

• Saleable stock

• Expired or damaged products

• Recalled or returned products

5.4 Stock Rotation (7.1.5)

• Apply FEFO (First-Expiry-First Out)

• Use FIFO if no expiry date exists

• Label expired/damaged items “Not for Use”

5.5 Delivery (7.2)

The organisation must:

• Use appropriate transport to protect product quality

• Prevent damage, contamination, tampering, or theft

• Deliver only to licensed or authorised recipients

5.6 Calibration (7.4)

Equipment used for:

• Storage condition monitoring

• Installation and servicing must be calibrated or verified at defined intervals against traceable standards.

6. Secondary Assembly (Clause 8) — If Applicable

Secondary assembly = placing the primary-packaged device into another packaging layer, without breaching the primary packaging.

6.1 General Requirements (8.1)

• Document procedures and work instructions

• Ensure controlled conditions and suitable equipment

• Maintain monitoring/measurement devices

6.2 Traceability Records (8.1)

Batch records must include:

• Traceability details

• Quantities assembled

• Approval for distribution Records must be verified and approved by authorised personnel.

  
  

6.3 Materials Control (8.3)

• Check incoming devices for package integrity

• Exclude devices with breached primary packaging

• Control packaging/printed material to prevent mix-ups

6.4 Labelling (8.3.3)

Secondary package labelling must:

• Match primary package information

• Comply with national regulatory requirements

7. Traceability (Clause 9)

Traceability records must:

• Track device movement from supplier to customer

• Support Field Safety Corrective Actions (FSCA)Records must include:

• Date

• Lot/batch/serial number

• Quantity

• Device name

• Supplier and customer details

Phase 3. Control and Compliance

8. Control of Counterfeit, Adulterated, or Tampered Devices (Clause 10)

The organisation must:

• Segregate and label such devices “Not for Use”

• Immediately notify the regulatory authority and product owner

9. Complaint Handling (Clause 11)

Requirements include:

• Documented complaint-handling procedure

• Handling of written and oral complaints

• Investigation and record-keeping

• Mandatory reporting of adverse events that meet national reporting criteria

10. Field Safety Corrective Action (FSCA) (Clause 12)

The organisation must:

• Establish FSCA procedures

• Notify the regulatory authority before executing the FSCA

• Inform overseas counterparts when exporting affected devices

• Maintain complete FSCA records and approvals

11. Internal Audit (Clause 13)

Internal audits must:

• Be performed at least annually

• Assess compliance with SS 620 requirements

• Define responsibilities for planning, execution, and reporting

• Investigate root causes of nonconformities

• Implement corrective actions without undue delay

12. Outsourced Activities (Clause 14)

The organisation must:

• Maintain control over outsourced processes

• Establish written contracts defining roles and responsibilities

14.1 Outsourced Clause 7 and Clause 8 Activities

• Storage, warehousing, stock handling, and secondary assembly providers must be audited by the certification body unless already SS 620-certified.

14.2 Internal Audit of Non-certified Providers

• If not SS 620 or equivalent certified, service providers must be audited as part of the organisation’s internal audit programme.

Summary

SS 620 Implementation Guide is like building a secure, well-managed distribution fortress for medical devices.

• The QMS functions as the blueprint.

• Management Responsibility ensures leadership oversight.

• Resource Management equips personnel with necessary competencies.

• Premises and Facilities serve as the protected storage environment.

• Traceability is the tracking system mapping every device movement.

• Complaint Handling and FSCA act as emergency response protocols to protect user safety.