In Order to regulate the medical device and IVD industry, the Govrenment of India introduced the Medical Device Rules 2017 which enables a workflow and approvals of each and every opeartor involved in the supply chain based on the activities they undertake.
Role of the Central Drugs Standard Control Organisation (CDSCO)
Primarily the Medical Devices including In-vitro diagnostic devices comes under the Ministry of Health and family Welfare, a autonomus govenrning body which is now National Regulatory Authority herein reffered as CDSCO (Central Drugs Standard Control Organisation). The CDSCO governs all the Healthcare System in India under the guidance of MoH&FW.The Medical Device divison is separately works which is dedicated to respond and facilitate the economic operators under the Medical Device Rules 2017
Purpose of Audit by Licensing Authority
The Licensing Authority whether (Central Licensing Authority, CLA or State Licensing Authority, SLA) conducts the audit to evaluate the ability of the economic operator to provide the applied products as per the quality standards which includes but not limited to;
- The Economic Operator has facility equiped with requisite machinery and manpower
- The Economic operator has facility to perform quality tests/inspection
- The Economic Operator has ability to handle customer complaints/FSCA etc under mandatory obligations
The Type of approvals/license given under certian conditions by CDSCO;
| Type of Application | Application Processed at/Audit | Notified Body Audit required | Inspection Report |
| Manufacturing License (Class A & B) Form MD-03, MD-04 | State FDA | Yes | MD-11, Audit Report from NB |
| Manufacturing License (Class C & D) Form MD-07, MD-09 | Zone, CDSCO HQ | Conditionally | Yes |
| Import License (Form MD-14, MD-26, MD-28) | CDSCO HQ | No | No |
| Test License (Form MD-16, MD-12) | CDSCO HQ | No | No |
| Clinical Investigation (Form MD-22) | CDSCO HQ | No | No |
| Clinical Performance Evaluation (Form MD-24) | CDSCO HQ | No | No |
| Personal License (Form MD-18) | CDSCO HQ | No | No |
Documents requirement and mandatory obligation
The audit carried by CLA/SLA requires docuementation as per Schedule IV and Schedule V of Medical Device Rules 2017 below are the basic documetation which needs to be required;
- Site/Plant Master File
- Quality Management System in accordance with Schedule V of MDR 2017
- Device Master Files of Each Product applied in the application
- Legal Documents of the Organisation and local mandates, NOCs etc.
Refer the - Mandatory Docuemnts
Procedure of Audit
After the scrutiniy of the application submitted by manufacturer/economic operator the licenseing authority issue a notice with the nomination of the Medical Device Officer appointed under Medical Devic Rules 2017. Upon receipt of the nomination the audit/inspection shall be carrried out for applied facility.
The Audit/inspection shall not be carried if;
- The Licensing Authority does not find applicant eligible to be inspected as per the submitted application, in such case queries are raised.
- The Licensing Authority finds any discrepency/falsified information in submitted application.
Common Non-Compliance Issues during CDSCO Audit
Below are the common findings which Medical Device Officer finds a non compliance
Company Legal Status
The organsation most of the time lacks, the legal documents which may include but not limited to
- Company Formation Documents (AOA, MOA, List of Directors and thier IDs)
- NOC from Local Authorities (If establishment is outside of controlled area)
- Factory License for Controlled area
Medical Records of Staff
The medical fitness of staff is carried out annually in which the organisation have to check the employees for basic health parametes (Preliminery Tests)
Availability of Technical Competent Person for Quality and Production
The Organisation must appoint Two technical person for quality and production (for manufacturer) and other than manufacturer, in order to maintian quality standards in the organisation.
Manufacturng Process and thier records
In most of the cases teh manufacturing records are not found aligned with the nature of devices, it is quiet understandable that documenting manufacturing records as per actual practice is quiet difficult, but it is always expected that documented records shall be in descriptive manner that they show every details which is required or important. below are the type of non conformities commonly raised
- The Device Record missing quality reports (inprocess)
- The Traceability is not maintianed in the device record
- The Mnaufacturing process does not include/aligned with in process quality check points
- The Manufactruing is carried out in batch wise but device manufcatured under the batch assigned distinct serial numbers
- Sterilization Process related validation records
Non-conformities raised due to misunderstanding or inappropriate justifications
Misinterpretation of Regulations
- Manufacturers may misinterpret regulatory requirements or guidelines, leading to non-compliance during the audit.
- Lack of clarity or understanding regarding specific regulatory standards may result in unintentional deviations from compliance.
- Inadequate training of personnel involved in manufacturing operations may contribute to non-conformities.
- Lack of awareness about regulatory standards and procedures may result in incorrect practices or decisions during the audit.
- Manufacturers may provide inappropriate or inadequate justifications for deviations from regulatory requirements identified during the audit.
- Failure to provide satisfactory explanations or evidence to support deviations can lead to non-conformities being raised.
All the possible cases and possibilities are included with perspective of Auditor/Inspector's perspective, However there may be some instances where the auditor may not be convinced then appropriate refrence towards issuing the non-compliance shall be recorded for answering.
- Please note Legal Complainces raised against the application shall be fullfilled prior to issuance of license, whereas other coomplaince would require Corrective and Preventive Actions.
- In any case the decison of Decision Authority deemed final.
If any clarification needed feel free to connect with us.
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