India announces the adoption of new amendments to current medical device regulations that will significantly change the whole medical device framework. In particular, the new document introduces changes to the Medical Devices Rules 2017 and the Drugs and Cosmetics Act 1940 – two core elements of India`s legislation governing operations with medical devices. The Department of Health and Family Welfare, India’s regulating authority in the sphere of medical devices, also noticed that the amendments were previously published for the purpose of public consultations to collect objections and suggestions from the industry representatives and other parties involved. It is also mentioned that all suggestions collected through public hearings have been properly taken into account by the Central Government in the process of new rules development.
The new regulations called the Medical Devices (Amendment) Rules 2020 will enter into force on April 1, 2020.
New Procedure of Medical Device Registration in India
First of all, the amendments cover the rules concerning the registration of medical devices with the Central Licensing Authority. According to the document, the general license would be provided via the online portal – “Online Medical Device System” managed by the Central Drugs Standard Control Organization. All medical device manufacturers will have to pass the registration within 18 months from the date when these changes take effect. For this period the registration is voluntary while after its expiration it will become mandatory. In particular, the manufacturer would have to upload the following information:
- Name of the company, including the address of the company itself and the manufacturing facilities,
- Description of a medical device, including name, brand name, intended purpose, class of the device, composition and materials, dimensions, shelf life, and the indication of whether the device is sterile or not.
- A certificate confirming compliance with the ISO 13485 standard issued by the appropriately accredited body.
- Assurance signed by the manufacturer to declare that all the information provided is correct and relevant.
Information provided by the manufacturer would be deemed true and correct, so the manufacturer will be responsible to maintain its accuracy and completeness.
Upon uploading all the aforementioned information to the online database, the manufacturer will be assigned with a special registration number. Then, the manufacturer will have to indicate the registration number or the label of a medical device.
Obligations of the Importer
Any person importing any medical device subject to regulation should also pass the registration procedure. For this purpose, an importer must upload the following information to the database:
- Name of the company importing the device,
- Description of a medical device, including name, brand name, intended purpose, class of the device, composition and materials, dimensions, shelf life, and the indication of whether the device is sterile or not.
- A certificate confirming compliance with the ISO 13485 standard issued by the appropriately accredited body.
- Assurance signed by the manufacturer to declare that all the information provided is correct and relevant.
- Free sale certificate issued in the country of origin.
As in the case with domestic medical devices, a device would be assigned with the registration number that should be indicated on the label.
According to the general rules, the provision of any additional registration documents and certificates issued by foreign national regulating authorities or duly accredited bodies would allow the importer to reduce the burden of compliance confirmation. First of all, it is required to provide documents confirming the registration in the country of origin, but if an applicant would be able to provide registration certificates issued in other countries it would be a plus.
The Central Licensing Authority, as a regulating authority, reserves the right to evaluate the document at any time, as well as the quality and safety of the device. The authority is also entitled to initiate investigations regarding any claims or failures (adverse events). In case if in the opinion of the regulating authority, a registered person (either manufacturer or importer) fails to fulfill any applicable rules, the authority will refuse in registration providing the reasoning for such refusal. The refusal could cover the device itself, and also any other related device. In case of refusal, the registration number would be null and void. At the same time, before providing the refusal, the authority allows the manufacturer (or the importer) to provide reasonable objections and demonstrate compliance with all applicable requirements.
Registration Period Exclusions
Despite the fact that the new Medical Devices (Amendment) Rules 2020 would take effect on April 1, 2020, for some types of medical devices the authority indicates an extended registration period providing medical device manufacturers with the additional time to properly prepare the documents and upload them via online portal as it is required under the new Rules. According to the registration period extension, several types of medical devices should be registered until January 2021 instead of the initial final date of January 1, 2020. In particular, the list of medical devices subject to extension includes:
- Glucometers,
- Digital thermometers,
- Blood pressure monitoring equipment, and
- Nebulizers.
At the same time, several other types of medical devices are subject to another extension. For such devices, the final registration date would be April 1, 2021. This rule covers the following devices:
- MRI equipment,
- CT scan equipment,
- PET equipment,
- X-Ray equipment,
- Defibrillators,
- Implantable devices,
- Dialysis systems,
- Bone marrow cell separation devices.
The previous final registration date for such devices was the end of 2019 – the beginning of 2020, but the authority decided to extend the period during which the manufacturers would be able to provide all the information required.
How Can RegDesk Help?
RegDesk is a next-generation web-based software for medical device and IVD companies. Our cutting-edge platform uses machine learning to provide regulatory intelligence, application preparation, submission and approvals management globally. Our clients also have access to our network of over 4000 compliance experts worldwide to obtain verification on critical questions. Applications that normally take 6 months to prepare can now be prepared within 6 days using RegDesk Dash(TM). Global expansion has never been this simple.
Sources:
