CDSCO Timelines

# Type of application Working Days
1 Grant of Test License to manufacture for test, evaluation, clinical investigations ets (MD-13) 30
2 Grant of import License (MD-15) 270
3 Grant of Test License for import for test, evaluation, clinical investigations, etc (MD-17) 30
4 Permission to Import small quantity of medical device for personal us (MD-21) 7
5 Permission to conduct clinical investigation (MD-23) 90
6 Permission to conduct clinical performance evaluation of new in vitro diagnostic medical device (MD-25) 90
7 Permission to improveimport or manufactire medical device which does not have its predicate device (MD-27) 120
8 Permission to import or manufacture new in vitro diagnostic medical devices (MD-29) 90
9 Certifivatr of registration to Medical Device Testing Laboratory for carry out carry out Test or Evaluation of a medical device on behalf of manufacturer (MD-40) 45
10 Licence / Loan License to Manufacture for Sale or for Distribution of Class A or Class B Medical Device (MD-5)/(MD-6):
10 a. For Class A Medical Devices:
10 i) Grant of license by SLA 45
10 ii) Audit of the manufacturing site by the registered Notified Body form the date of issue of License by SLA 120
10 b. For Class B Medical Devices:
10 i) Audit of the manufacturing site by the registered Notified Body from the date of application 90
10 ii) Inspect Report submitted to SLA 30
10 iii) Grant of license by SLA 20
11 licence / loan License to Manufacture for Sale or for Distribution of Class C or Class D medical device (MD-9)/(MD-10)
11 a. Completion of scrutiny for the date of online submission of application 45
11 b. Inspection of manufacturing permises for the date of application 60
11 c. Grant of license from the date of reseipt of inspection report 45
12 Application for post approval change in manufacturing Licenses Prior approval to be obtained from CLASLA in major change 45
13 Application for post approval change in Import Licenses Prior approval to be obtained from CLA/SLA in major change 60
# Type of application Working Days
1 New Drugs / Investigational New Drugs
1 a. IND Applications in consultain with subject Expert Committee (SEC) 30
1 b. New Drug including Biological, / Clinical Trials/ Global Clinical Trails/New Claims in consultation with Subject Expert Committee (SEC) 90
1 c. Subsequent New Drugs (SND) with Subject Exper Committee (SEC) 90
1 d. Fixed Dose Combination in consultation with Subject Exert Committee (SEC) 90
2 Import Registration of Drugs & Biologicals 270
3 Import License in Drugs & Biological 45
4 Import post approval changes for drugs:
4 a. Major 180
4 b. Minor 90
5 Endorsement of Additionsl Poduct in Registration certificate 12
6 Rule 37 & Neutral Code 60
7 Grant of permission for manufacturing of: 7
7 a. New drug or investigational new drug for CT, BA or BE study or for examination, test and analysis (CT-11)
7 b. Formulation of unapproved API for test or analysis or CT or BA or BE study (CT-14)
7 c. Unapproved active pharmaceutical ingredient for the development of formulation for test or analysis or CT or BA or BE study (CT-15)
8 CLAA in Form 28/28-D128-E/27-C etc. 60
9 Licence to import new drug or investigational new drug for the purpose of clinical trial or bioavailability or bioequivalence study or for examination, test and analysis (CT-17) 7
10 Permission to conduct Bioavailability / Bioequivalence (BA/BE) Study for new drug or investigational new drug (CT-07) 90
11 Extension of Shelf Life for export 45
12 Registration of Cosmetics 90
13 Registration of Ethics Committee (CT-02) 45
14 Biological Post Approval Changes
14 a. Major in consultation with CDL, SEC 180
14 b. Minor 90
15 Permission for BA-BE study and its Post Approval Changes for export purpose 15
16 Registration of BA/BE study center (CT-09) 90
17 Written Confirmation (WC) as per EU Directives 20
18 Permission to Import small quantity of drugs for personal use 3