Hello Priya,
There is no guidance on the time interval to update the Plant Master File (PMF).
Since this document is included along with the Quality Manual requirements, it needs to stay current.
This means the change management should take care of the update in PMF along with Quality Manual.
Thanks.
------------------------------
Nilesh Rajule, PhD
linkedin.com/in/nileshr
Bangalore, India
------------------------------
Original Message:
Sent: 22-Mar-2023 17:48
From: Priya Patel
Subject: India plant master file requirement for medical devices
Do you need to update the Plant Master File at a certain period? Is there any guidance/requirement on that?
Thank you!
Original Message:
Sent: 27-Dec-2022 06:59
From: Nilesh Rajule
Subject: India plant master file requirement for medical devices
1. Yes, the plant layout must be submitted as a part of the Plant Master File
- All applications for the manufacture or import of medical devices, made to Central Licensing Authority (CLA) or State Licensing Authority (SLA), need to submit the documents as specified by the Fourth Schedule of Medical Devices Rules, 2017.
- Part III Appendix I of the Fourth Schedule outlines the contents of the Plant Master File. Please refer to this section of Medical Devices Rules, 2017 to determine the contents.
- The layout of the premises with an indication of scale must be submitted in section 3. Premised and Facilities of Plant Master File.
- Also, the manufacturer must maintain the Plant Master File as a part of the Quality Manual mentioned in the Fifth Schedule for QMS requirements.
- Environmental requirements for some devices are outlined in Annexure A of the Fifth Schedule. Please check if your devices fall under this list.
2. Post-approval changes must be evaluated as per the Sixth Schedule of Medical Devices Rules, 2017
- The Sixth Schedule categorizes changes into major and minor.
- You will need to evaluate if the change in plant layout leads to major or minor post-approval change.
- Major change requires prior approval from CLA or SLA. If no communication of approval or rejection is received within the stipulated time, the change shall be deemed to have been approved. [Rules 26 (iii), 38(v), and 38(vi)]
- Minor change shall be informed to CLA or SLA within a period of 30 days after such change takes place. [Rules 26 (iv) and 38(vii)]
------------------------------
Nilesh Rajule PhD
Bangalore
India
Original Message:
Sent: 20-Dec-2022 18:40
From: Anonymous Member
Subject: India plant master file requirement for medical devices
This message was posted by a user wishing to remain anonymous
Hello,
What level of information is needed for the medical devices plant master file in India?
- Does plant layout need to be submitted?
- If there is any internal change within the approved facility, is manufacturer required to do a change notification?
Thank you!