P03 Medical Devices

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

Resource summary

	Created by Sheela Eroyna about 8 years ago