BIS Certification for manufacturing medical devices in India is a mandatory quality assurance process, regulated under the Medical Device Rules 2017, ensuring products meet safety standards (ISI mark). The process involves online application via Manakonline, factory inspection, product testing at BIS-recognized labs, and license issuance
Foreign manufacturers exporting medical devices to India must obtain BIS certification under the Foreign Manufacturers Certification Scheme (FMCS) to ensure compliance with Indian Standards (IS), mandatory for customs clearance and legal sale. The process involves appointing an Authorized Indian Representative (AIR), testing samples in BIS-recognized labs, factory inspection, and submitting documents like flowcharts, and quality control records.
The Bureau of Indian Standards (BIS) is India’s National Standards Body responsible for the harmonious development of standardization, quality certification, and marking of goods.
Established under the Ministry of Consumer Affairs, Government of India, BIS ensures product quality, safety, reliability, and consumer protection through certification schemes including ISI Mark Certification and product registration programs.
For medical devices, BIS certification demonstrates compliance with applicable Indian Standards and regulatory requirements.
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