FDA Registered Medical Device Manufacturers in India

 

FDA is known as Food and Drug Administration in the United States which was established in 1906. FDA is responsible for protecting public health, it helps the people through ensuring the security of the food and drug supplying chain. It provides science-based information scanning the medical products and foods to maintain the quality of food and its production.

Why medical device manufacturing companies need FDA Registration?

FDA inspect the variety of consumer product, including drugs, foods and medical devices, cosmetic product, vaccines, products containing tobacco, products that emit radiation.

If you want your product to reach to the customer in the United State FDA approval is more than necessary and a primary requirement for your product, to be distributed also in the global market, it goes the same with the medical devices as well. All the medical devices should be FDA Approved, once it is approved by the FDA, and then it can be distributed to the market.

It assures that a particular device or a product is safe for the public and it is good to get launched in the market. During FDA assessment products and devices go through with the clinical trial and approval process is done by various regulatory bodies then it lasts it gets approval through the FDA. If a product or device is not FDA approved, manufacturers are not allowed to use FDA log and label in the market on their device or product.

Medical Devices are classified into one of the three regulatory classes such as Class I, Class II, Class III 

Top FDA Registered Medical Device Manufacturer

Johari healthcare Pvt. Ltd:

Johari is one of the largest manufacturers of physiotherapy and medical aesthetic Devices. It is one of the first Indian Manufacturer of FDA Registered Medical Device. The company is innovating and developing health benefiting technologies and manufacturing solutions. The company is widely recognized as a premier manufacturer of Class I, Class II, and Class III medical products to the medical and life sciences industries.

Highlights of Pre-market Submission – 510(k) / PMA

• In 1989, The company received first 510(k) clearance for Class II medical device – Transcutaneous Electrical Nerve Stimulator.
• In 2009, the company have received our first 510(k) clearance for a class III medical device.
• In 2019, The company have received fifteen 510(k) clearances – Class II, III OTC (Over The Counter) under Johari ownership and additional ten 510(k) clearances for our clients.

 

To know more about the compnay and its approved devices list : visit:  Joharidigital.com

 

 

Tags # FDA # FDA Registered # Medical Device