USFDA not mandatory for Medical Devices: DOP releases Guideline for public procurement
New Delhi: Giving relief to domestic medical device makers, the government has asked the procurement agencies to follow the Bureau of Indian Standards (BIS) for procuring such devices and not to mandate the USFDA/CE certifications where the norms laid down by the national standard body exist.
“Every procurement agency should follow the standards laid down by Bureau of Indian Standards (BIS), for the medical device concerned, for the procurement purposes,” the Department of Pharmaceuticals has said in an official memorandum. Where such standards exist, USFDA/CE certifications etc shall not be mandated, it added.
This issue of mandatory requirement of USFDA/CE certification in public procurement has been raised time and again by medical device industry representatives, the memorandum said. The department has considered the issue and has amended the guidelines dated May 18, 2018, issued for the implementation of PPO 2017 regarding this. The other guideline of the May remain unchanged, it added.
Commenting on the development, Association of Indian Medical Device Industry (AiMeD) Forum Coordinator Rajiv Nath told PTI: “While we thank the DoP for intending to support domestic manufacturers we now wish the letter to be reissued with a corrigendum.”
We seek the letter to state “while USFDA may be a sufficient condition it cannot be a mandatory condition in bid participation. An eligible manufacturer may have ISO/ICMED Quality Management Systems Certification from a NABCB accredited Certification Body or the manufacturers may have a CE/USFDA/CDSCO regulatory approval to be considered to be qualified for a tender,” he added.
This will ensure wider participation in the bidding process and more competitive choices available to the buyer, Nath said. “We requested the Government to give preference to ICMED (Indian Certification for Medical Devices ) Certification from QCI and incentivise manufacturers to seek this certification for ensuring better quality,” he added.
“Every procurement agency should follow the standards laid down by Bureau of Indian Standards (BIS), for the medical device concerned, for the procurement purposes,” the Department of Pharmaceuticals has said in an official memorandum. Where such standards exist, USFDA/CE certifications etc shall not be mandated, it added.
This issue of mandatory requirement of USFDA/CE certification in public procurement has been raised time and again by medical device industry representatives, the memorandum said. The department has considered the issue and has amended the guidelines dated May 18, 2018, issued for the implementation of PPO 2017 regarding this. The other guideline of the May remain unchanged, it added.
Commenting on the development, Association of Indian Medical Device Industry (AiMeD) Forum Coordinator Rajiv Nath told PTI: “While we thank the DoP for intending to support domestic manufacturers we now wish the letter to be reissued with a corrigendum.”
We seek the letter to state “while USFDA may be a sufficient condition it cannot be a mandatory condition in bid participation. An eligible manufacturer may have ISO/ICMED Quality Management Systems Certification from a NABCB accredited Certification Body or the manufacturers may have a CE/USFDA/CDSCO regulatory approval to be considered to be qualified for a tender,” he added.
This will ensure wider participation in the bidding process and more competitive choices available to the buyer, Nath said. “We requested the Government to give preference to ICMED (Indian Certification for Medical Devices ) Certification from QCI and incentivise manufacturers to seek this certification for ensuring better quality,” he added.
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