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Class A Non-Measuring/Sterile Devices Now Exempt from MD-15 Requirements
Published on: November 14th, 2022
On October 14, 2022, the Indian Ministry of Health and Family Welfare issued final notification G.S.R. 777(E) formalizing the exemption of Class A non-measuring and non-sterile medical devices from the Import License (MD-15) process.
Initially proposed in the draft notification G.S.R. 710(E) on September 20th, 2022, Class A medical devices that are non-measuring and non-sterile must immediately register through a quick online registration process similar to the voluntary registration process after this most recent final notification from the MoHFW. This significantly simplifies market access for low-risk medical devices in India, creating an expedited pathway to market access for Class A device manufacturers.
If you have any questions about this new final notification from the MoHFW and the exempt status of Class A devices from the import license process in India, please contact us here.
Updated India Medical Device Regulations
With this update, the Medical Device (Sixth Amendment) Rules, 2022, exempts Class A non-sterile and non-measuring medical devices from the licensing regime by adding a new Chapter IIIB to the MDR 2017. This includes a requirement for registration of Class A (non-sterile and non-measuring) medical devices through a link on the cdscomdonline.gov.in portal. As a result, no import license (MD-14/MD-15) is required for the import of these devices. However, Class A sterile devices and Class A measuring devices will require the import license and the application procedure for obtaining an import license for such medical devices remains unchanged.
Common non-measuring and non-sterile devices include items such as:
- Some examination gloves, etc.
Simplified Registration Route for Non-Measuring/Sterile Devices
Class A non-measuring and non-sterile devices don’t need to submit Device Master File (DMF) or Plant Master File (PMF). This is important because many manufacturers will outsource their Class A Non-M/S instruments and now don’t need to register that manufacturing site AND the products’ DMF. This can save up to 9 months of review time, more extensive document preparation, and hundreds or thousands of dollars in CDSCO fees.
Importers of Class A non-sterile and non-measuring medical devices have been exempted from all provisions of the following chapters of the Medical Devices Rules, 2017:
- Chapter V – Import of medical devices,
- Chapter VII – Clinical investigation of medical device and clinical performance evaluation of new invitro diagnostic medical device,
- Chapter VIII – Import or manufacture medical device which does not have predicate device,
- Chapter XI – Sale of medical devices
Class A Exempt Registration Requirements
Importers are still required to upload information about the products to the MOHFW’s online system for medical devices, which includes the following product information:
- Generic Name
- Brand Name (if registered under the Trade Marks Act, 1999)
- Model No. (if any)
- Intended use
- Material of construction
- Dimension (if applicable)
- Shelf life (if applicable)
Additionally, the manufacturer or importer remain in charge of their own documentation as it relates to their Class A product. For example:
- The manufacturer, importer or local partner/license holdershall maintain the records relating to manufacturing or importing along with its sales or distribution,
- The manufacturer or importer shall produce the records, labels, instructions for use, on request by Licensing Authorities,
- The Licensing Authorities may verify the records and documents at any point of time and investigate quality or safety related failures or complaints.
Compliance Requirements for Class A Non-Measuring and Non-Sterile Devices in India
Further necessities for showcasing Class A status include:
- Clear documentation that the proposed devices are Class A Medical Devices and are non-sterile and non-measuring,
- Self-certification from the Importer that the product conforms to the essential principles checklist of safety and performance of such devices,
- Self-certification from the Importer that the product conforms to MDR 2017, Rule 7 Product standards for medical device,
- Self-attested copy of the overseas manufacturing site or establishment or plant registration, by whatever name called, in the country of origin issued by the competent authority or Free Sale Certificate issued by the National Regulatory Authority,
- A signed undertaking from the importer that the information provided is true and authentic,
- A registration number will be provided after the details have been submitted online.
For applicants who have already applied for Class A non-sterile, non-measuring devices on the cdscomdonline.gov.in portal, this input of details will require the applicant to manually upload each and every model number and all details again in the new portal. The new online system provides no option for portability of submitted data from the prior one.
Unlike the Voluntary Registration, this Rule does not mention any requirement for submission of details of accessories and components of Class A non-sterile and non-measuring. This is because the manufacturer has to demonstrate that the proposed devices are Class A Medical Devices that are both non-sterile and non-measuring.
These products also face no restriction for the Free Sales Certification (FSC) to be from the country of origin or from the GHTF countries of USA, UK, Japan, Canada, Australia or the EU. It can be from any country, unlike the current requirement.
Come Grow With Us
Please contact us if you need more information on medical device registration in India. Asia Actual has an office in India located in Delhi staffed by experienced, bilingual regulatory and commercial professionals that will address any questions or provide support.
Asia Actual is a regulatory consulting company specializing in helping manufacturers grow their sales through independent license holding, direct fulfillment, and a variety of sales channel support services.