| Our
customers¡G
Medical
products manufacturers; distributors and importers; research
insitutes; hospitals and clinics; universities; and government
agencies.
Services¡G
U.S. FDA
510(k) third party review; Quality system regulation(Good Manufacturing
Practice) training; Product safety and performance standards
training.
Items¡G
- Medical
device regulation:
U.S. Food, Drug and Cosmetic Act, European Union Directives:
AIMD, MDD, and IVMD; Japan Pharceutical Affairs Law; Canada
Medical Devices Regulations; Australia Therapeutic Goods
Act; and R.O.C. Pharmaceutical Affairs Law.
- Premarket
review:
FDA 510(k) Third Party Review
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Medical
device regulation
- Please
tell us the intended use of your product including the descriptions
of device functions and technology characteristics, and
indication for use
- OMDE
will prepare a comprehensive information of FDA premarket
requirements for your product. The information includes
classification, CFR code, safety and performance requirement,
and FDA recorgnized standards(if applicable)
- OMDE
will explain the regulatory requirements to you and answer
your questions at a meeting held in CMS. Service charge:
NT$6,500(tax included)
510(k)
Third Party review
- OMDE
performs 510(k) third party review according to the requirement
of FDA. A meeting between OMDE and 510(k) applicant will
be available for each submission if there is deficient information.
- A review
report will be prepared by OMDE for applicant. ¡@
- FDA
AP ¡G
- Manufacturer
are encouraged by FDA to utilise the Third Party program
under FDA Modernization Act. OMDE currently is accredited
by FDA for 194 items of medice devices premarket notification..
- Service
charge is NT$200,000(tax included) and may be differ according
to the particular device. Please contact OMDE for details.
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