Regulatory Classes Medical devices

MedSpark Technical Glossary and Design Terminology

Xinhua News Agency, Beijing, January 20 (Reporter Hu Hao) - State Food and Drug Administration recently issued a circular, colored contact lens plano contact lenses will be included in regulatory areas, in accordance with Class III medical devices for control.

It is understood that the market of decorative color plano contact lenses generally, in the eyes of consumers to wear to decorate and change the color of the cornea.

However, the current color plano contact lenses in unattended state. Accordance with the "Supervision and Regulation of Medical Devices" on the definition of medical devices, this is only for decoration, the product does not have a correct vision, because it did not have the disease, injury or disability prevention, diagnosis, treatment, monitoring, mitigation and compensation The role does not belong to medical equipment, medical equipment and thus not included in the scope of regulation.

State Food and Drug Administration said that with the people's material and cultural life of the continuous improvement of quality, color plano contact lenses may be used more and more. If the lack of management, product quality and other issues may cause users to be hurt. In order to protect the public safety of using color plano contact lenses, color contact lens plano contact lenses will be included in regulatory areas, in accordance with Class III medical devices for control.

State Food and Drug Administration will soon release the announcement until after the announcement, without obtaining a certificate of registration of medical devices are not allowed to produce and sell the product. Meanwhile SFDA is studying the development of specific regulatory measures, the product research, production, operation and use and overall supervision.

Neo G Neo G Closed Toe Pantyhose Compression hoisery Large Tan- Medical Grade 20-30mmHg
Health and Beauty (Neo G)
  • Helps reduce symptoms of varicose veins, prenatal varicose veins and light ulcers
  • Helps reduce symptoms of tired, aching legs, mild oedema (edema) & swelling
  • Graduated Compression: maximum compression at the ankle, gradually decreases up the leg, helping aid circulation
  • Microfiber material for comfort, softness and breathability
  • Class 1 Medical Device, registered with the MHRA (Medicines and Healthcare products Regulatory Agency, UK)
2011-04-18 10:26:37 by NewMsLoree

This is scary... and long...

The Free Speech About Science Act (H.R. 1364), “health freedom,” and misinformed consent
“Health freedom.” It’s a battle cry frequently used by supporters of “alternative” medicine against what they perceive to be persecution by the medical and scientific establishment that uses the Food and Drug Administration, the Federal Trade Commission, and other federal agencies charged with regulating pharmaceuticals, food, cosmetics, and medical devices in order to protect the public against fraud, adulterated food, and quackery. It’s a potent argument to those not versed in skepticism and science-based medicine, and even to many who are

2003-10-21 21:53:47 by dermdoc

Clarification on lasers

I think you are referring to the following statement:
"Several manufacturers received FDA permission to claim, "permanent reduction," NOT "permanent removal" for their lasers. This means that although laser treatments with these devices will permanently reduce the total number of body hairs, they will not result in a permanent removal of all hair. The specific claim granted is "intended to effect stable, long-term, or permanent reduction" through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs re-growing after a treatment regime, which may include several sessions

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Neo G Neo G Tennis/Golf Elbow Clasp- Medical Grade with comfort pad- Medical Grade, Breathable, Slimline Design
Health and Beauty (Neo G)
  • Helps/Used For - Epicondylitis e.g. Tennis/Golfer s elbow, strains, sprains, injured, weak or arthritic elbows, rehabilitation, sporting and occupational injuries
  • Fully adjustable Variable Compression System for optimum support and compression and blood flow safety
  • Our unique fastening design allows Universal sizing which fits either the left or right side and is suitable for both men and woman.
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  • Class 1 Medical Device, registered with the MHRA (Medicines and Healthcare products Regulatory Agency, UK)

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