Regulations & Policy
AiMED flags concern over fake certifications issued to med device manufacturers
IMT News Desk -
1 year ago
AiMED flags concern over fake certifications issued to med device manufacturers
IMT News Desk -
1 year ago
Writes to MoH&FW to take proper action
Ethical medical device manufacturers are facing challenges from fake and unauthenticated certificates that are not accredited by National Accreditation Board for Certification Bodies (NABCB), International Accreditation Forum (IAF), or even the US FDA website. The Association of Indian Medical Device Industry (AiMED) has raised this issue with the Union Health Ministry for proper action to be taken against non-accredited certification bodies. This will result in fake certification bodies not issuing certificates. It may be noted that manufacturers are misled to take shortcuts due to attractive pricing.
There needs to be a registry on MoH&FW or Central Drugs Standard Control Organisation (CDSCO)'s website of accredited certification bodies as well as registration of certification bodies which are reportedly accredited to forewarn buyers/ unsuspecting buyers and even newly launched startups.
Aimed mentions that instead of allowing buyers for seeking US FDA and CE certificates MoH&FW should seek from GeM to give the option of NABCB-accredited ISO and Indian Certification for Medical Devices (ICMED) certificates for non-notified medical devices in its tenders and additionally ask for manufacturing registration/ manufacturing licences from CDSCO.
