Good News for Pakistani Exporters of Medical & Surgical instruments to USA!!

US Food & Drugs Adminsitration, FDA, Exempts the Pakistani firms (manufacturing surgical & medical instruments), from “Detention Without Physical Examination”, after getting compliance verification by Third party “Quality System Audit & Regulation Program”

DETAILS: U.S. Food & Drug Administration

Import Alert 76-01                                    Report by: Dr. Taha Inam

Import Alert # 76-01

Published Date: 19/May/2014

Type: DWPE; (Detention Without Physical Examination)

Import Alert Name: “Detention Without Physical Examination Of Medical Instruments from Pakistan”

[(Note: This import alert represents the Agency’s current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public.]

 Link (1): http://www.accessdata.fda.gov/cms_ia/importalert_224.html

Reference detailed Link to be followed:

Link (2): http://www.mdiconsultants.com/Publishing/Articles_9_12_12_APS.htm)

Reason for Alert:

NOTE: The revision of this Import Alert dated 10/03/2011 updates the Guidance section and Reason for Alert section to reflect current Agency thinking regarding removal from detention without physical examination.

Background: The report is about Pakistani companies who manufacture the surgical & medical instruments which imported by USA to be used in their highly credible hospitals and medical institutes at their Operation Theatres (OTs), Intensive Care Units (ICUs), High Dependency Units and Emergency Room (ER). This indeed is very proudly information that our nation has the manufacturers who are capable of making surgical instruments of export levels, and that also to the most developed country America; as mostly we are hesitating and demoralized in the international and national media market canvas that ‘Pakistan is not capable of making, developing or producing anything, specially of international quality standards?’.

The other fact; that must be disclosed and informed to the reader of Dimension Research (DR)’newsletter, that, this is not the first time or not only Pakistani firms that are given the import alerts, on the Detention Without Physical Examination; but there are lists of number of companies from all over the developing and developed countries, which are in regular updates of FDA.

For more details of alerts of multiple product’s reader is suggested to visit the FDA main website; www.fda.gov, and check the headings of Recalls, Warnings and Industry Recalls, or go directly through the below.

‘DWPE’ Link (3): http://www.accessdata.fda.gov/cms_ia/ialist.html

Let us come to this titled alert which details the compliance issues in early 1991, where US FDA issued an import alert on the import of stainless steel surgical instruments, providing the guidance that that the instruments appeared to be ‘violative’ under section 501(c) of the Act, as the quality of the instruments appeared to fall below that which they were purported or represented to possess.

The import alert was put in place after documented analysis revealed great variability in ‘chromium content’, causing concern that medical instruments manufactured from Pakistan were not compliant with the quality system regulations. FDA implemented a third party Quality System Audit Program to verify the compliance of manufacturers of medical instruments intended to be distributed within the United States. This third party auditor verification was coupled with sample analysis regimen to exempt firms from “Detention Without Physical Examination”.

FDA after reviewing this program recently now believes that ‘verification of firms’ compliance with the Quality System Regulation’ should be sufficient evidence to exempt a firm from Detention Without Physical Examination without any additional sampling regimen.

These firms will be placed in Green List of this import Alert. The complete alert and Green Listed Pakistani companies, which are around (Eleven hundred and fifteen), 1115, in numbers, mostly in Sialkot and other cities of Pakistan could be seen through link (1) of alert given above.

 

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