Overview:
The Health Science Authority (HSA) released a guidance in response to the COVID-19 demand for medical devices like nasopharyngeal swabs, personal protective equipment, face shields and respiratory accessories.
Regulatory Controls Applicable For 3-D Printing:
Medical devices in Singapore are classified in 4 risk-based categories, Class A through D (Class A being the lowest risk). As per HSA, 3-D printing essential medical devices includes,
Class A: External prosthetics, face shields and nasopharyngeal swabs
Class B: Breathing circuits ventilators tubes, and connectors
Class C: Dental or orthopedic implants
Class D: Cranial implants and heart valves
Registration of 3-D Printing Md in Singapore:
To register 3-D printing medical devices in Singapore regulatory requirements needs to be followed for the following:
- Dealer Licensing: The manufactures or importers should have a valid dealer’s license from HSA and the GMP requirements should be followed as per the ISO 13485.
- Registration and notification: For Classes B, C and D, the devise should eb registered with HSA. For class A medical devices, HSA should be notified on the HSA website. All medical devices should comply with the Medical Device guidance published on June 2018.
- Post marketing: Manufacturers and health care professionals must report any changes in the lifecycle, safety, risks, adverse effects, allergies, infections (due to sterilization), adverse effects, failure to perform its intended function or death to the HSA. The agency will investigate to resolve issues from reoccurring.
Technical Considerations:
To maintain the safety and performance standards, the manufacturing companies needs to consider the following as per the guidance:
Design consideration
- Definition and identification of Dimensional specification, Critical features (location and thickness of porous features), material specification, physical parameters
- Should follow applicable ISO/ASTM standards
- Clinical verification of parts of the device during manufacturing
Device Validation
- Evaluation of Biocompatibility, mechanical and performance validation (tensile strength, fatigue or abrasive wear), performance testing on final device, Sterilization process should be conducted
Labeling and expiration date
- The label should include sufficient information of identity (to trace the device) and instructions for safe and effective use including warnings, precautions and contraindications (if any).
Manufacturing
- Additive and post-manufacturing should be performed in compliance with ISO 13485 QMS
- Additive manufacturing method, agents and process flow should be specified
Regulatory Corner:
- All 3-DP medical devices must comply with the Essential Principles of Safety and Performance.
- Commercially produced Class B, C and D 3-DP medical devices must be registered with HSA before they can be supplied.
- Class A 3-DP medical devices do not require registration with HSA only notification.
About Global Regulatory Partners:
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices and pharmaceutical companies globally. GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and Argentina. GRP helps many life science companies register their products in different countries in compliance with local regulations.. To learn more, please contact us at info@globalregulatorypartners.com