CDSCO Registration for Medical Devices in Algeria
Are you a medical device manufacturer or exporter in Algeria looking to enter the Indian market? CDSCO registration is mandatory to import, sell, or manufacture medical devices in India. Operon Strategist helps Algerian manufacturers and Indian importers obtain the required licenses with full regulatory compliance.
What is CDSCO Registration?
The Central Drugs Standard Control Organization (CDSCO) is India’s national regulatory authority for medical devices. It ensures products meet safety, quality, and performance standards under the Medical Device Rules, 2017.
CDSCO Registration Process
For Importing Devices:
Form MD-14 must be submitted by an Indian importer via the SUGAM portal.
Required documents:
Free Sale Certificate
Power of Attorney
ISO 13485 Certificate
Device Master File
Clinical Evaluation & Labels
For Manufacturing in India:
Algerian companies setting up Class A or B manufacturing units must apply for Form MD-15.
Documents needed:
Device Master File (DMF)
Site Master File (SMF)
ISO 13485
Validation & clinical data
Declaration of conformity
Why Choose Operon Strategist?
10+ years of regulatory expertise
Assistance with CDSCO, CE Marking, FDA 510(k), SFDA, SAHPRA & more
Complete support: Dossier preparation, submission, importer coordination, post-approval compliance
📩 Get in touch: https://operonstrategist.com/en-dz/services/regulatory-approvals/cdsco-registration/?utm_source=Google&utm_campaign=Offpage7
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