Zusammenfassung der Ressource
P03 Medical Devices
- Classification
- GMD
- IVD
- Regulation
- HSA Health Products Regulation
Group
- Pre-market cluster
- Medical devices
- Post-market cluster
- Vigilance and compliance
- Dealer's licensing
- Health Products Act, Section 12-14
- Importer's license
- Wholesaler's license
- Manufacturer's license
- Product registration
- Regulated under
- Health Products (Medical Devices) Regulations of HPA
- Health Products Act, Section 29-34
- GN-15
- Listed In SMDR
- Check who the product registrant of the medical device
- MD vs not MD
- MD
- Diagnosis
- Prevention/ Treatment
- Monitor
- Investigation
- Support/ Alleviate
- Not MD
- - Body toning
equipments
- Magnetic accessories
- Massagers
- A/E Reporting
- Fill up MDAR1 form
- Submit to Medical device branch
- Healthcare professional
- Fill up MDAE reporting form
- Submit to vigilance & compliance branch
- Report immediately
- Within 48 hours
- Represent serious threat to public health
- Within 10 days
- Events that has led to death
- Serious deterioration in the state of health
- Within 30 days
- Recurrence might lead to death
- Serious deterioration in the state of health
- Complaint
- GN-07
- 1. Record
- 2. Investigation + Record
- 3. Take action + Record