Overview Of Medical Device Rules, 2017:
The vision of medical device rules, 2017 is “To Protect and Promote public health in India.”
The mission of medical device rules, 2017 is “To safeguard and enhance the public health by assuring the safety, efficacy and quality of drugs, cosmetics and medical devices.”
Under the 2017 Rules, medical devices mean:
“Specific devices intended for internal or external use in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals which are notified by the government from the time to time under the Drugs and Cosmetics Act, 1940 (“D&C Act”). Some categories of devices have already been notified by the government.”
Voluntary Registration of Medical Devices:
Voluntary registration of medical devices typically refers to a process by which manufacturers or distributors of medical devices choose to register their products with a regulatory authority, even if such registration is not legally required. This can offer several advantages, both for the manufacturers and for the safety and quality assurance of the medical devices themselves.
Here are some key points to consider regarding voluntary registration of medical devices:
Market Access: Voluntary registration can help manufacturers gain faster and easier access to markets. While some countries might not require mandatory registration for certain types of medical devices, voluntary registration can still demonstrate the device's compliance with quality and safety standards.
Credibility and Trust: Voluntary registration can enhance the credibility of a medical device manufacturer and build trust with healthcare professionals and patients. It signals a commitment to adhering to regulatory standards and ensuring product quality.
Safety and Quality: Registration, whether mandatory or voluntary, often involves submitting documentation that demonstrates the device's safety and effectiveness. This can involve clinical data, technical specifications, labeling information, and more. Voluntary registration can lead to a more rigorous evaluation of the device's safety and quality, ultimately benefiting patient safety.
Competitive Advantage: Manufacturers that voluntarily register their devices might have a competitive advantage over those that don't, as they can market their devices with an additional level of assurance and quality verification.
International Harmonization: In some cases, voluntary registration can align a manufacturer's products with international standards, facilitating export to countries with more stringent regulatory requirements.
Documents Required for Voluntary Registration of Medical Device:
These are the various documents required for voluntary registration of medical device.
Application Form: Most regulatory authorities will require you to complete an application form that provides essential information about the medical device, its intended use, manufacturing details, and your company information.
Device Description: Detailed technical documentation describing the device's design, intended use, and specifications.
Device Labeling and Instructions for Use: This includes the device's labeling, packaging, and user manuals. These documents should clearly explain how the device should be used, precautions to take, and any potential risks associated with its use.
Quality Management System (QMS) Documentation: This may include your company's Quality Manual, Standard Operating Procedures (SOPs), risk management documentation, and other documents related to your quality control processes.
Clinical Data: Depending on the risk classification of the device and its intended use, you might need to provide clinical data demonstrating the safety and effectiveness of the device. This could include clinical study reports, post-market surveillance data, and clinical evaluations.
Technical Specifications: Detailed technical information about the device's construction, materials, components, and manufacturing processes.
Biocompatibility Data: Information on the device's biocompatibility, including biocompatibility testing reports.
Sterilization Information: If applicable, documentation related to the sterilization process used for the device.
Risk Assessment: Detailed risk assessment documentation, including hazard analysis and risk mitigation strategies.
Declaration of Conformity: A document stating that the device conforms to the relevant regulatory standards and requirements.
Certificate of Free Sale (CFS): Some countries or regions might require a CFS to show that your medical device is freely sold and legally marketed in your home country or region.
Authorized Representative Information: If your company is not located within the region where you are seeking registration, you might need to provide information about your authorized representative in that region.
Fee Payment: There might be registration fees associated with the application process.
Unique Device Identification (UDI): If applicable, information about the UDI assigned to your device.
Procedure for Voluntary Registration of Medical Device:
The maker or importer is required to post the necessary documentation on the online portal in accordance with Rules 19C and 19E of Chapter IIIA of the Medical Devices (Amendment) Rules, 2020. The registration number for the medical device will thereafter be generated by CDSCO. The manufacturer and importer will get the registration after providing the information that has been posted to the "Online System for Medical Devices". On the device's label, they must also include the registration number they got.
The voluntary registration process is only available for medical devices that have not been notified. The following steps must be taken by the applicant in order to register a medical device voluntarily:
Prior to applying, the candidate must go to the CDCSO website's official online portal.
The applicant must next proceed by clicking the portal's registration link.
The candidate must then enter their Name, Email address, and mobile number after clicking the link.
The candidate must then upload the following files:
I.D. proof, a corporate address proof, and details from the company's certificate of incorporation a replica of the wholesale and manufacturing license
The applicant must validate the registration by entering the four-digit OTP that was sent to the registered mobile number after the details have been uploaded.
The applicant can log into their account after registering.
Time Period And Validity of Voluntary Registration of Medical Device:
Class A and B device registration is initially optional for 18 months before becoming mandatory for 12 months. Class C and D medical device voluntary registration will be valid through September 30, 2023. Mandatory registration will take effect on October 1, 2023. Manufacturers or importers must register Class C and D devices for 24 months after 18 months of voluntary registration.
Rejection of Voluntary Registration of Medical Device:
The rejection of a voluntary registration of a medical device typically refers to the denial of an application submitted by a manufacturer or distributor to a regulatory authority for the purpose of obtaining approval or clearance to market and sell a medical device in a particular jurisdiction.
Here's an overview of what might lead to the rejection of voluntary registration for a medical device:
Incomplete or Inaccurate Documentation: If the application is missing essential information or contains inaccuracies, it can result in rejection. Regulatory authorities require detailed documentation about the device's design, intended use, manufacturing processes, safety data, and more.
Non-Compliance with Regulations: Medical devices are subject to strict regulations to ensure patient safety and device effectiveness. If the submitted application does not meet these regulatory requirements, it is likely to be rejected. This could include issues with labeling, performance testing, clinical data, and quality control.
Lack of Clinical Evidence: For higher-risk medical devices, clinical data demonstrating safety and efficacy might be required. If the submitted clinical evidence is insufficient or does not meet the regulatory standards, the application could be rejected.
Insufficient Risk Management: Medical devices are assessed based on their potential risks to patients and users. If the application does not adequately address risk management strategies or fails to mitigate potential risks, the registration might be rejected.
Conclusion:
Voluntary registration of medical devices typically refers to a process where manufacturers choose to register their medical devices with the regulatory authority even if it's not legally mandatory. This can be done to demonstrate compliance with quality and safety standards and to gain market credibility. The time period and validity of voluntary registration can vary depending on the regulatory framework of the country or region in question.
To guarantee that high quality and standards of products are presented to the market, the government has informed regarding voluntary registration for medical devices in an official notice. Until the officially declared date, the voluntary registration will be applicable to medical devices that have not been notified. Once the deadline has passed, all medical devices must register in order to use them.
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