The PFDA Citizen Charter is a key document that outlines the processes and roles of its various departments. This document includes guidelines and procedures for license to operate, food, drug, cosmetic, and medical device registration.
CDRRHR, a branch of PFDA, ensures the safety and effectiveness of medical devices and radiation-emitting products. It plays a crucial role in protecting public health through its mission of evaluating, monitoring, and regulating these essential technologies.
While the CDRRHR Citizen Charter for 2023 has seen several changes compared to its 2022 edition, the following summary specifically addresses the turnaround time for product registration and notification certificates.
Initial Application
|
Application Type |
Citizen Charter 2022, Processing Time (Working Days) |
Citizen Charter 2023, Processing Time (Working Days) |
|
|
Initial |
Certificate of Medical Device Notification (CMDN) |
20 |
25 |
|
Class B Certificate of Medical Device Registration (CMDR) |
69 |
80 |
|
|
Class C and D CMDR |
97 |
110 |
|
|
In Vitro Diagnostic (IVD) Devices/Reagents Certificate of Product Registration (CPR) |
90 |
105 |
|
|
Renewal |
Class A CMDN/CMDR |
24 |
20 |
|
IVD CPR |
24 |
20 |
|
|
Variation (CMDN/CMDR/IVD CPR) |
42 |
20 |
|
Compliance
|
Application Type |
Citizen Charter 2022, Compliance (Working Days) |
Citizen Charter 2023, Compliance (Working Days) Initial/Renewal |
|
|
Compliance |
Certificate of Medical Device Notification (CMDN) |
NA |
NA |
|
Class B, C and D Certificate of Medical Device Registration (CMDR) |
5 |
20 |
|
|
In Vitro Diagnostic (IVD) Devices/Reagents Certificate of Product Registration (CPR) |
76 |
20 |
|
|
Variation (CMDN/CMDR/IVD CPR) |
42 |
20 |
|
Other Application Type
|
Application Type |
Citizen Charter 2022, Processing Time (Working Days) |
Citizen Charter 2023, Processing Time (Working Days) |
|
|
Certificate of Medical Device Listing (CMDL) |
11 |
20 |
|
|
Certificate of Free Sale (CFS) |
10 |
20 |
|
|
Compassionate Permit |
7 |
7 |
|
|
Sales Promo Permit (Initial/Amendment) |
7 |
7 |
|
|
Equipment/Devices Used to Treat Sharps, Pathological, and Infectious Wastes |
Initial |
40 |
50 |
|
Renewal |
20 |
20 |
|
|
Turned Initial |
40 |
50 |
|
|
Water Purification Devices/System |
Initial |
40 |
50 |
|
Renewal |
25 |
20 |
|
|
Turned Initial |
40 |
50 |
|
|
Application Type |
Citizen Charter 2022, Processing Time (Working Days) |
Citizen Charter 2023, Processing Time (Working Days) |
|
|
Certificate of Safety Evaluation (CSE) |
20 |
20 |
|
|
License to Operate (LTO) of X – ray Facilities |
Initial |
50 |
20 |
|
Renewal |
20 |
10 |
|
|
Certificate of Facility Registration, CFR (Initial/Renewal) |
20 |
10 |
|
|
Minor and Major Variation (LTO and CFR) |
20 |
15 |
|
|
Pre – Operational Permit for Therapeutic X – ray Facilities |
20 |
15 |
|
|
Issuance of Clearance for Customs Release (CFCR) |
3 |
3 |
|
|
Issuance of Certificate of Compliance (COC) |
Initial |
50 |
15 |
|
Renewal |
20 |
20 |
|
|
Issuance of Certificate of Registration (COR) for Magnetic Resonance Imaging (MRI) Facilities (Initial/Renewal) |
20 |
20 |
|
|
Amendment (COC/COR) |
20 |
20 |
|
Other important updates to the citizen charter include the following:
|
● |
Easier navigation of the specific transaction of interest. Unlike the previous version, where one whole file for all the transactions for each center was provided, PFDA now provides guidelines according to the different transactions available. The stakeholders can now look up their transaction of interest instead of skimming through the lengthy file. |
|
● |
Additional guidelines for abridged approval routes |
|
● |
Additional guidelines for class B-D CMDR applications for those applied beyond 120 days after the expiration date of the previous certificate. All requirements now follow the initial CMDR applications. The fees to be paid were also included, including the surcharge and penalty fees. |
|
● |
A more comprehensive list of CPR variation items for medical devices, in-vitro diagnostic devices, and reagents is provided. Some of the requirements for some types of variation or amendment were also updated to include more technical proof for the proposed changes. |
References:
Posting of Updated FDA Citizen’s Charter