A draft amendment on the #Medical device rules 2017 was notified on 20th September 2022, which informed about the various provisions related to registration of Class A (Non-Sterile and Non-Measuring) Medical Devices.
According to the notification, a new chapter is inserted as Chapter IIIB in the rules, which regulates these medical devices under the First Schedule of The Medical Device Rules, 2017.
Before getting into the details of provisions of the draft amendment, let’s first know about the medical device rules, 2017, and the body regulating it.
The Central Drugs Standard Control Organization or #CDSCO is the highest regulatory body in India that keeps a check on rules and regulations related to Medical Devices. CDSCO is responsible for approving licenses to manufacture and Import medical devices in India. it regulates the Import, sale, distribution, manufacture, clinical trials etc. Medical Device Rules, 2017 are notified by CDSCO. The medical devices have also been classified into four classes according to the risk associated with each device, where class A lists Low-Risk Devices, Class B lists Low to Medium Risk Devices, Class C lists Medium to High-Risk Devices and Class D lists High Risk Devices
There are also certain documents to be submitted by the manufacturers and Importers to get CDSCO registration,
The Documents required for the same. Both #manufactures and #Importers are required to submit some common documents other than some exclusive requirements.
The list of documents that are commonly required by both manufacturers and Importer for getting a registration.
1. Name and Address of the manufacturing site, In case of an Importer, the name and address of Importers are also required additionally..
2. Details of the medical device, such as-
a. Generic Name
b. Brand Name ( If the device is registered under Trade Marks Act, 1999)
c. Model no. (If any)
d. Intended use
e. Material of Construction
f. Dimension (If applicable)
g. Shelf life ( If applicable)
3. Undertaking from the manufacturer and the Importer that the proposed medical device is a Class A medical device including (non-sterile and non-measuring medical device, according to Schedule I of the medical device rules, 2017.
4. Self- certification from the manufacturer and Importer stating that the medical device conforms to the essential principle and checklist of safety and performance of the device
5. Self-certification from the manufacturer and Importer stating that the medical device complies with the standards prescribed in the medical device rules, 2017.
Last, but not the least,
6. Undertaking signed by the manufacturer and importer stating that the information furnished by the applicant is genuine and authentic.
Other than these documents to be submitted by manufacturers and importers in common, the importer has to submit an extra document of Self-attested copy of the overseas manufacturing site or establishment or plant registration in the country of origin, issued by the competent authority or Free Sale Certificate issued by the National Regulatory Authority.
There are some essential points which are to be followed by manufacturers or importers while obtaining registration for Class A (Non-Sterile and Non-Measuring) Medical Devices, let’s learn about them.
• The manufacturer or importer is required to maintain the records of manufacturing or import along with the record of sales or distribution.
• On request by Licensing Authorities, the manufacturer or importer is required to produce the records, Instructions and labels.
• The Licensing Authorities may verify the documents or records, at any time to investigate the quality or safety-related failures or complaints.
A basic fact that not all registration applications are approved by the licensing authorities and failure to comply with rules and guidelines may cause rejection of the application. The State Licensing Authority or the Central Licensing Authority may cancel or suspend the registration number for a certain period after allowing the applicant to show why the registration should not be rejected or suspended. If the application gets rejected or suspended, the aggrieved person may file an appeal to the State or the Central Government within forty-five days of the passed order. The State or the Central Government then may pass an order to confirm, modify or reverse such order if satisfied by the appellant.
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