PMDA vs CDSCO: Medical Device Regulatory Comparison
Compare the medical device registration pathways, classification, and regulatory requirements of PMDA (Japan) vs CDSCO (India).
PMDA
Pharmaceuticals and Medical Devices Agency (Japan)
Japan
Japan's PMDA conducts scientific reviews of medical device applications under the PMD Act. Japan uses a four-class system with three pathways: Todokede (notification) for Class I, Ninsho (third-party …
Class I, II, III, IV
Todokede / Ninsho / Shonin
- ▸Shonin pre-market approval
- ▸Ninsho third-party certification
- ▸QMS inspection (MHLW Ordinance 169)
- ▸PMDA consultation (Taimen Joshu)
- ▸Foreign Manufacturer Registration
CDSCO
Central Drugs Standard Control Organization (India)
India
India's CDSCO regulates medical devices under the Medical Devices Rules 2017 (amended 2020). India uses a four-class system (A, B, C, D). India is the fastest-growing major medical device market globa…
Class A, B, C, D
CDSCO registration / import license
- ▸Medical device registration
- ▸Import license (Form MD-14)
- ▸Clinical investigation approval
- ▸Quality management system audit
- ▸Adverse event reporting
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