Thai FDA is committed to ensuring utmost standard, quality and safety of medical devices marketed in Thailand is consistently kept. Hence, they have announced a new medical device complaint channel, complaint record and management system for inspection. This decree is beneficial in providing assurance to consumer regarding safety and prevention of comparable adverse event in the future.
Qualtech has translated the official decree from Thai language, for everyone to refer to details on this new system. Please refer to following:
“Complaint management System means the procedure for handling complaints, includes investigation, analysis, review of the information related to the cause investigation, field safety corrective action as well as keeping complaint record and any practices that has been handles regarding the complaints.
2. Establishment Importer Licensee / Licensed MD Licensee / Notified MD licensee / General MD Licensee must provide medical device complaint channels, complaint records and complaint management system as follow:
(1) Responsible party shall provide at least one of complaint channels as follow:
(a) Complaint center
(b) Telephone number or Fax
(c) E-mail or website
(d) Electronic contact channel e.g. Facebook, Line, QR Code
(2) Complaint record for inspection must be kept at place of manufacturing, importation, or distribution with details as follow:
(a) Complainant information
(b) Complaint date
(c) Complaint channel e.g. Complaint Channel, Fax, Facebook, Line, QR Code etc.
(d) Medical device information such as:
1) Medical device name
2) Indication or intended use
3) Numbers or alphabets indicating manufacturing LOT or serial number
4) Cat. No./Part No. (If any)
5) Software version or Model No. (If any)
6) Composition or accessory (If any)
7) Amount of related medical devices (If any)
8) Physical manufacturer name and address
(e) Complaint details
(f) Medical Device complaint report on device defect or adverse effect or others
(g) Complaint management
1) Complaints investigation
2) Correction action
3) Prevention action
(h) Assessment and end the complaints
1) Correction action result
2) Double check result
3) Assessor name
3. Complaint record for inspection must be prepared in hard copy or electronic copy at place of manufacturing, importation, or distribution for more than 1 year and not less than 5 years after its manufactured date.
4. Establishment importer Licensee / Licensed MD Licensee / Notified MD Licensee / General MD Licensee must provide complaint summary report to inspector within 30 days from requested date. In case of any emergency or life-threatening conditions it is mandatory for responsible parties to provide complaint summary report within 48 hours from requested date.
5. This decree will be implemented from May 4, 2021 onwards.