Medical Device Registration in Thailand

1 Executive summary
1.1 “overview – explanation in general for this product
have information of concentration and source of HA”
1.2 Intended use and Indication
1.3 History of marketing & marketing authorization in other countries, esp. reference countries: USA, EU, Canada, Australia and Japan, with their valid licenses, see Table next sheet
1.4 Registration status in other countries, e.g. during submission for approval, pending, rejection, etc., see Table next sheet
1.5 important safety/performance related information, see Table next sheet
2 Essential Principles of Safety and Performance of Medical Device and method used to demonstrate conformity
3 Device Description
3.1 “General description & principle
– general description & principle of product
– ingredient formulation of product – must refer to Pharmacopia and version of each ingredient
– Source of origin of HA
– packaging detail of material used of primary packaging
– photographs of product – selling packaging and outer box and quantity per unit
“
3.2 Intended use
3.3 Indications
3.4 Instructions for use
3.5 Storage condition, e.g. temperature
3.6 “Shelf life report (stability test: accelerate test & real time test)
– must follow ICH Guideline for Stability Testing of New Drug Substances and Products or ASEAN Guideline on Stability Study of Drug Product. If using other developed methods must submit method validation”
3.7 Contraindications
3.8 Warnings
3.9 Precautions
3.10 Potential adverse effects
3.11 Alternative therapy
3.12 “Materials and properties of product;
– must attach MSDS (Material Safety Data Sheet) and material specification of each ingredient
– monograph of each material
– CoA of each material
– if contain drug, e.g. lidocaine must submit Part S – Drug substance of this drug”
3.13 “Other relevant specifications of finished product
– must have specification for testing must have testing for gel property e.g. cohesivity , water uptake, elastic modulus (G’) etc”
3.14 Other descriptive information (if have)
4 Summary of design verification and validation documents
Pre-clinical Studies
(a) Biocompatibility studies of Gel and needle – follow update ISO10993 standard – if not updated version, must have gap analysis for explanation
Cytotoxicity
Sensitization
Irritation
Acute Systemic Toxicity
Subacute/subchronic Toxicity
Genotoxicity
Implantation
(b) Physical test data (full paper – objective, method, test result & summary of product)
including testing of cohesivity , water uptake, elastic modulus (G’) etc.
“(c) BioSafety information of HA:
1. Indicate material that from source of animal, human, bacteria or genetic engineering
2. Detail of source of origin
3. Detail of sample collection, manufacturing process, how to storage, testing and arrangement of this cell/material
4. process validation results, to prove that manufacturing process can minimize biological safety risk, esp. virus and transmitted microorganism
5. Information of traceability from origin until finished product”
Clinical evidence
Clinical evaluation report, including CV of evaluator
Sterilization validation
Bioburden test
Pyrogen test
Sterilant residue test
Packaging validation test
Sterility assurance level attained
5 Device labeling
Package Label – package sold to consumers must in Thai language, except no. (1) to (7) can be in English:
(1) Name of product
(2) Active ingredient & concentration
(3) Quantity per package
“(4) – Name & address of Importer
– Name of physical manufacturer, with City and Country”
(5) Month Year of manufacture (year 4 digits)
(6) Month Year of expiration (year 4 digits)
(7) Batch or Lot no.
(8) License number
(9) Storage condition
(10) Indication for use & instruction for use – can put in package insert
(11) Warnings, Precaution, Contraindication – can put in package insert
(12) Wording “Please read package insert before use” or symbol
(13) Wording “Sterile & method” or symbol
(14) Wording “Be careful, fragile” or symbol
(15) Wording “Temperature range of storage” or symbol
(16) Wording “Avoid sunlight” or symbol
(17) Wording “Don’t use if package is damaged” in “red font” or symbol
(18) Wording “Single use” in “red font” or symbol
Package insert (Instruction for Use), in Thai language
(1) Name of product
(2) Active ingredient & concentration
(3) Quantity per package
“(4) – Name & address of Importer
– Name of physical manufacturer, with City and Country”
(5) License number
(6) Storage condition
(7) Indication for use & instruction for use – can put in package insert
(8) Warnings, Precaution, Contraindication – can put in package insert
(9) Wording “Sterile & method”
(10) Wording “Be careful, fragile”
(11) Wording “Temperature range of storage”
(12) Wording “Avoid sunlight”
(13) Wording “Don’t use if package is damaged”
(14) Wording “Single use”
(15) Wording “Hyaluronic acid is used for skin correction and used only by healthcare professional or dentist”
(16) Revision date of the IFU
Package artwork of all levels
6 Risk analysis Summary & result of risk analysis, complied to ISO 14971 Application of risk management to Medical Device
7 “Manufacturer information:
– Manufacturing site name & address
– Manufacturing process flow-chart and explanation each step, including equipment for manufacturing & control, environment or manufacturing condition
– Quality system management; SOPs to ensure good manufacturing practice, for manufacturing, packaging, labeling, storage “
8 Destruction information after use
9 Certificate of free sale – legalized through Thai Embassy
10 GMP/ISO Certification of the physical manufacturing site. If using copy, must certified true copy directly by notary public, not company person to certify copy and notary public just certify that person, then legalized at Thai Embassy
11 Declaration of Conformity – template as required by Thai FDA, will draft for the manufacturer to issue
12 Letter of Authorization – template as required by Thai FDA, will draft for the manufacturer to issue