Prior approval / evidence record
Japan PMDA
- Benefit
Named in Rule 36(3) and in the Rule 63(1) proviso, so both the clinical investigation waiver and the no-predicate relief are available.
- Timeline Savings
None published — the saving is the clinical investigation, not the clock
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
Class C
- Pathway
Registration with clinical data
- Verification Status
official-verified
- Official Source
- Title
CDSCO Medical Devices Rules, 2017 (G.S.R. 78(E))
- Url
https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2022/m_device/Medical%20Devices%20Rules%2C%202017.pdf
- Prior Approval Benefits
- GHTF country approval with predicate
- Notes
- Rules 21(4)/25(1): CDSCO document scrutiny within 45 days (restartable on deficiency rectification), then licence decision within 45 days of the site-inspection report
- Clinical data required
- Clinical Trial Required
Yes
- Local Testing Required
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
IndiaUS FDA · EU conformity assessment · Australia TGA · Japan MHLW / PMDA · GHTF Prior approval / evidence record
Class A
- Verification Status
official-verified
- Official Source
- Title
CDSCO Medical Devices Rules, 2017 (G.S.R. 78(E))
- Url
https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2022/m_device/Medical%20Devices%20Rules%2C%202017.pdf
- Prior Approval Benefits
- GHTF country approval (FDA, EU, Japan, Australia, UK)
- Notes
- Licence granted or rejected within 45 days of application (Rule 20(4)); Notified Body audit happens within 120 days after licence grant, not before (Rule 20(4) proviso (ii))
- GHTF approval provides significant advantage
- Clinical Trial Required
No
- Local Testing Required
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
Class D
- Pathway
Registration with extensive clinical
- Verification Status
official-verified
- Official Source
- Title
CDSCO Medical Devices Rules, 2017 (G.S.R. 78(E))
- Url
https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2022/m_device/Medical%20Devices%20Rules%2C%202017.pdf
- Notes
- Rules 21(4)/25(1): CDSCO document scrutiny within 45 days (restartable on deficiency rectification), then licence decision within 45 days of the site-inspection report
- Indian clinical trials may be required
- Clinical Trial Required
Yes
- Local Testing Required
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
UK MHRA
- Benefit
Named only in the Rule 63(1) proviso, which waives clinical investigation results for a no-predicate device marketed in the UK for at least two years. The UK is not in the Rule 36(3) list.
- Timeline Savings
None published
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
IndiaEU conformity assessment Prior approval / evidence record
EU CE Mark
- Benefit
A free sale certificate from an EU country triggers the same Rule 36(3) waiver of clinical investigation. The EU is not named in the Rule 63(1) proviso, so a no-predicate device still needs the MD-27 route.
- Timeline Savings
None published — the saving is the clinical investigation, not the clock
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
BRICS regulators cooperation MoU (NMPA party): no recognition effect
reliance.china-nmpa-bilateral-programme
- Statement
CDSCO and China's NMPA are both parties to the BRICS regulators' Memorandum of Understanding (together with ANVISA, the Russian Ministry of Health, Ministry of Industry and Trade and Roszdravnadzor, and SAHPRA), listed by CDSCO as valid until 31 January 2029. The instrument is a cooperation MoU and creates no recognition of NMPA approvals in India.
- Source Jurisdiction Id
china
- Source Approval
China NMPA medical device registration certificate (Class II/III) or Class I filing record
- Target Jurisdiction Id
india
- China Classes In Scope
Not class-specific; regulatory-cooperation instrument only
- Market Access Strength
none
- Regulatory Layer
Product Marketing
- Local Application Required
Yes
- Target Decision Retained
Yes
Conditions
- Multilateral (BRICS), not a bilateral India-China device MoU
- Cooperation/information-exchange instrument; no legal effect on licensing
- Independent verification is incomplete. Treat this record as a research lead, not a confirmed benefit or exclusion; see the 2026-09-15 independent review.
Source passage: 04 BRAZIL, RUSSIA, INDIA, CHINA, SOUTH AFRICA (BRICS) Memorandum of Understanding (MoU) ... The Central Drugs Standard Control Organization of The Republic of INDIA (CDSCO) ... The National Medical Products Administration of The People's Republic of CHINA (NMPA) ... 31.01.2029
Prior approval / evidence record
FDA 510(k)/PMA
- Benefit
A free sale certificate from the United States triggers Rule 36(3): the import licence is granted without clinical investigation. Rule 63(1) fourth proviso additionally waives clinical investigation results for a device without a predicate if it has been US-approved and marketed there for at least two years. Neither provision shortens the nine-month Rule 36(1) decision period.
- Timeline Savings
None published — the saving is the clinical investigation, not the clock
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
Australia TGA
- Benefit
Named in Rule 36(3) and in the Rule 63(1) proviso, so both the clinical investigation waiver and the no-predicate relief are available.
- Timeline Savings
None published — the saving is the clinical investigation, not the clock
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
- Statement
For devices imported from countries outside the rule 36(3) list, Class C and D licences may be granted only after safety and effectiveness are established through clinical investigation in India, and Class A and B licences after published safety and performance data or a clinical investigation in the country of origin plus a free sale certificate from the country of origin. A China NMPA registration certificate or the NMPA-based free sale certificate therefore serves only as the country-of-origin documentary evidence required with Form MD-14/MD-15; it gives no abridged review.
- Source Jurisdiction Id
china
- Source Approval
China NMPA medical device registration certificate (Class II/III) or Class I filing record
- Target Jurisdiction Id
india
- China Classes In Scope
NMPA Class II/III certificate or Class I filing used as country-of-origin evidence; Indian Class A/B (rule 36(5)) and Class C/D (rule 36(4))
- Edge Type
Origin Country Evidence
- Market Access Strength
Evidence Only
- Regulatory Layer
Product Marketing
- Local Application Required
Yes
- Target Decision Retained
Yes
Conditions
- Class C/D: clinical investigation in India under Chapter VII (rule 36(4))
- Class A/B: published safety/performance data or clinical investigation in the country of origin, and a free sale certificate from the country of origin (rule 36(5))
- Import application must also include notarized copy of overseas manufacturing site registration in the country of origin and the Free Sale Certificate 'issued by the National Regulatory Authority or equivalent competent authority of the country concerned as referred under rule 36'
- Independent verification is incomplete. Treat this record as a research lead, not a confirmed benefit or exclusion; see the 2026-09-15 independent review.
Effective from 2018-01-01
Source passage: (4) Where a medical device is imported from countries other than those referred to in sub-rule (3), the licence in case of Class C and Class D medical devices may be granted after its safety and effectiveness has been established through clinical investigation in India as specified under provisions of Chapter VII of these rules. (5) Where a medical device, is imported from countries other than those referred to in sub-rule (3), the licence in case of Class A or Class B medical devices may be granted after its safety and performance has been established through published safety and performance data or through clinical investigation in the country of origin and a free sale certificate from the country of origin is furnished.
Prior approval / evidence record
Class B
- Verification Status
official-verified
- Official Source
- Title
CDSCO Medical Devices Rules, 2017 (G.S.R. 78(E))
- Url
https://cdsco.gov.in/opencms/resources/UploadCDSCOWeb/2022/m_device/Medical%20Devices%20Rules%2C%202017.pdf
- Notes
- Rule 20(6) chain: Notified Body audit within 90 days of application, NB report to the licensing authority within 30 days of the audit, licence decision within 20 days of the audit report (140 days total)
- Licence grant-or-reject clock is 45 days where it applies (Rule 20(4))
- NABL testing may be required
- Clinical Trial Required
No
- Local Testing Required
Yes
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Prior approval / evidence record
Health Canada
- Benefit
Named in Rule 36(3) and in the Rule 63(1) proviso, so both the clinical investigation waiver and the no-predicate relief are available.
- Timeline Savings
None published — the saving is the clinical investigation, not the clock
Maintained reference · planning ranges remain estimates · reviewed 2026-08-30
Regulatory reference
- Statement
Rule 36(3) of the Medical Devices Rules, 2017 grants the import licence without an Indian clinical investigation only where a free sale certificate has been issued by the national regulatory authority of Australia, Canada, Japan, an EU country or the United States (the United Kingdom was added by amendment in 2022). China/NMPA is not on the list, so an NMPA registration certificate does not trigger the clinical-investigation waiver.
- Source Jurisdiction Id
china
- Source Approval
China NMPA medical device registration certificate (Class II/III) or Class I filing record
- Target Jurisdiction Id
india
- China Classes In Scope
All NMPA classes; concerns Indian import licence (Form MD-15) for Class A-D devices
- Edge Type
No Reliance Route
- Market Access Strength
none
- Regulatory Layer
Product Marketing
- Local Application Required
Yes
- Target Decision Retained
Yes
Conditions
- List is exhaustive: Australia, Canada, Japan, European Union countries, United States of America (plus United Kingdom by the 2022 amendment, not reflected in the consolidated CDSCO text quoted)
- Devices from other countries fall under rule 36(4) (Class C/D) or 36(5) (Class A/B)
- Independent verification is incomplete. Treat this record as a research lead, not a confirmed benefit or exclusion; see the 2026-09-15 independent review.
Effective from 2018-01-01
Source passage: (3) Where, a free sale certificate has already been issued in respect of any medical device by the national regulatory authority or other competent authority of any of the countries namely, Australia, Canada, Japan, European Union Countries, or the United States of America, a licence shall be granted under sub-rule (1) to the applicant without carrying out clinical investigation.
