GMP regulations Medical devices

Regenerative medicine and regulation: what s GMP got to do with it

The following content is for reference only; vendors handle cases when treated in accordance with the opinion of the contractor personnel.

Question 1: Application of domestic medical equipment GMP evaluation What basic qualifications required?

Reply: The vendor shall obtain registration certificate and manufacturing plant drug dealers license license, registration certificate and the address of the factory manufacturing drug dealers to be covered by the He Shi Permit the address.

Question 2: Are all the domestic medical equipment must apply GMP evaluation?

Reply: no. Meet the medical equipment management approach items in Annex II to the non-sterile medical equipment, may be exempt from GMP evaluation. However, free GMP Annex II evaluation of products, still follow the application product inspection and registration.

Question 3: Where can I get an application?

Reply: manufacturers can connect to the Internet through the Department of Health website for the keyword "Good Manufacturing Practice compliance application for medical devices" search, you can find links to download.

Question 4: In addition to an application other than what information should be prepared to be sent to the Department of Health?

Reply: The vendor shall prepare the following documents to the Department of Health:
1 Application 2. Ministry of Economic Affairs factory registration certificate 3. Manufacturing drug dealers Permit 4. Factory quality manual 5 fee.

Question 5: How should fill out the application form?

Reply: Delivery before confirmation applications require that the project has been completed or checked. If it does not understand, he shall be related to the case of contractor personnel opinions prevail.

Question 6: Application, applicants approved registration of medical devices and English names and how to determine the classification and grading code should?

Reply: manufacturers can refer to the Department of Health medical equipment management practices in Annex I to decide. If you can not clearly determine, have to pay fees and submit relevant information to the health inquiry concerning classification and grading of medical equipment items and mode of administration: Another judge may refer to the following information:

Original product manual (or directory) and its detailed Chinese translations (including the use of methods, functions and working principle).

U.S. or EU classification and grading of the reference product.

Other items designated by the central competent health authority designated information.

GMP manufacturing and product evaluation Range items are based, rather than the same items as the basis of different specifications, so the items should not be compared with the crown before the name of the brand name. In addition, if a medical equipment management approach annex no applicable items name, in line with product inspection and registration, please provide detailed product information for the relevant contractor personnel for reference, and discuss appropriate items name.

2006-02-20 17:02:02 by Bioseeker

8 years in biotech

I've been working consistently in the biotech field, after a BA in Psychobiology for 8 years.
-Regulatory Affairs deals with getting FDA approval of new drugs and medical devices.
I went to the Biospace job fair last month but haven't got any calls. I'm wondering if its b/c I currently reside in LA. I'm thinking of moving down there and looking for something fast thru a temp agency. Any advice?

2009-01-11 15:13:59 by windshadow

More from hsi

Last month, a group of FDA scientists sent an SOS to Representative John D. Dingell, chairman of the House Committee on Energy and Commerce. The letter calls for "urgent intervention" due to "serious misconduct" by managers of the Center for Devices and Radiological Health (CDRH) – the FDA division that oversees everything from imaging equipment to breast implants.
So what constitutes "serious misconduct"?
Here's how the scientists put it: "There is extensive documentary evidence that managers at CDRH have corrupted and interfered with the scientific review of medical devices

2007-09-08 13:08:25 by -------

Chip implants shown to cause cancer, a

-
"When the U.S. Food and Drug Administration approved implanting microchips in humans, the manufacturer said it would save lives, letting doctors scan the tiny transponders to access patients' medical records almost instantly. The FDA found "reasonable assurance" the device was safe, and a sub-agency even called it one of 2005's top "innovative technologies."
But neither the company nor the regulators publicly mentioned this: A series of veterinary and toxicology studies, dating to the mid-1990s, stated that chip implants had "induced" malignant tumors in some lab mice and rats

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