The CDSCO seeks for suggestions and comments from the Medical Device Industry on the draft notification on self-certification process for Class A (non-sterile and/or non-measuring) medical devices.
Class A medical devices are those with 'low to moderate' risk to the patient or user. All Class A manufacturers are awaiting audits from the government licensing authorities even after receiving a manufacturing license. This new self-certification process would make this transition process lot easier.
The manufacturer must give the following information through the identified online portal for medical devices.
1. Name and address of the manufacturing site.
2. Details of the medical device like
- generic name,
- brand name,
- intended use,
- material of construction,
- shelf life, etc.
3. Undertaking stating that the proposed device is Class A medical device – non-sterile and/or non-measuring.
4. Self-certify that the product is conforming to the essential principle's checklist of safety and performance of such devices.
5. Self-certify to comply with the standards prescribed in Medical Devices Rules, 2017.
6. Undertaking by the manufacturer stating that the information furnished is true and authentic.
7. Self-attested copy of the overseas manufacturing site or establishment or plant registration, or Free Sale Certificate issued by the National Regulatory Authority for import license applications.
After submitting the information in the online system for medical devices, a 'Registration Number' will be generated. This Registration Number can be added to the label for sale in India.
The applicant needs to maintain the records of manufacturing/ import along with its sales or distribution. The records, labels, Instructions for Use, need to be provided on request by Licensing Authorities. The Licensing Authorities may verify the records, documents at any point of time and investigate quality or safety related failures or complaints.
Please refer to Self-Certification for Non-Sterile and/or Non-Measuring Class A Medical Devices
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| Self-Certification for Non-Sterile and/or Non-Measuring Class A Medical Devices |
| The CDSCO seeks for suggestions and comments from the Medical Device Industry on the draft notification on self-certification process for Class A (non-sterile and/or non-measuring) medical devices. Class A medical devices are those with 'low to moderate' risk to the patient or user. |
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Sravan Kumar Manchikanti, RAC
Hyderabad
India
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