ADVANTAGES01
20+ Years of
Professional Experience
ADVANTAGES02
Successful Registration of
NEW Medical Devices
ADVANTAGES03
Professional Regulatory
Consulting Services
ADVANTAGES04
QSD and License
Holder Management
ABOUT US
Elite RA Consultancy Co., established in 2004, is one of Taiwan's leading professional
regulatory consulting companies specializing in medical device registrations.
We provide a full range of services for both domestic and international medical device
manufacturers, including medical device registration in TFDA, regulatory consulting,
and product license management.
OUR SERVICE
01
Quality System Documentation (QSD)
QSD Registration, Change, Renewal
02
Medical Device Registration
- Class I, Class II (510K), Class III (PMA) Medical Device
- Annual Declaration of Medical Devices
- License Change
03
Other Services Related to Medical Devices
Advertising Application, Trademark Application, Post-market Surveillance (PMS) Report.
04
QSD, License Holder Representation, and License Management
As a neutral third-party license holder, we can ensure the circulation and operational flexibility of products in the market.
05
TFDA Regulatory Consulting
Assistance in QSD, inspection and registration, advertising copywriting, post-market monitoring reports, etc.
OUR EXPERIENCE
Experience in NEW Medical Device Approval
Experience in
NEW Medical Device Approval
NEW Medical Device Approval
| TFDA Category | Item |
|---|---|
| Cardiovascular Device | Cardiovascular Stent, PTCA catheter, Percutaneous catheter |
| Gastroenterology and urology devices | Urethral dilator |
| General, plastic surgery and dermatology devices | Silicone gel-filled breast prosthesis, Hyaluronic Acid implant |
| Neurological Devices | Artificial Embolization Device |
| Ophthalmic devices | Soft Contact Lens, Soft Contact Lens for Children Myopia Control, IOL |
| Physical medicine devices | Computed Tomography X-Ray System |
Experience in General Medical Device Approval
Experience in
General Medical Device Approval
General Medical Device Approval
| TFDA Category | ||
|---|---|---|
| DAnesthesia devices | ECardiovascular devices | FDental devices |
| GEar, Nose, and Throat devices | HGastroenterology and Urology devices | IGeneral, plastic surgery, and dermatology devices |
| JGeneral hospital and personal use devices | KNeurological devices | LObstetrics and Gynecology devices |
| MOphthalmic devices | NOrthopedic devices | OPhysical medicine devices |
| PRadiology devices | OtherIn Vitro Diagnostic Medical Device (IVD) | |