MEDICAL DEVICES REGISTRATION SERVICES
Approval of Non Notified Devices
Does Import or Manufacture of Non Notified Products Require NOC or Registration?
As per the Notification No.G.S.R. 102 (E) dated 11 Feb 2020 which is called Medical Devices (Amendment) Rules, 2020 and the said Rules Shall come into effect from 1st April 2020, Scrutiny and Regulatory approvals shall be mandatory for all products beyond the approved 37 Notified categories.
As per, Notification number 648(E) .Under the Medical Device Rules 2017, It was clarified that the following types of devices will be considered as drugs from 1st April 2020.
“All devices including an instrument, apparatus, appliance, implant, material or other article, whether used alone or in combination, including a software or an accessory, intended by its manufacturer to be used specially for human beings or animals which does not achieve the primary intended action in or on human body or animals by any pharmacological or immunological or metabolic means, but which may assist in its intended function by such means for one or more of the specific purposes of ―
(i) diagnosis, prevention, monitoring, treatment or alleviation of any disease or disorder;
(ii) diagnosis, monitoring, treatment, alleviation or assistance for, any injury or disability;
(iii) investigation, replacement or modification or support of the anatomy or of a physiological process;
(iv) supporting or sustaining life;
(v) disinfection of medical devices; and
(vi) control of conception.
Understanding the Regulation for Registration of Certain Medical Devices CHAPTER IIIA :
19A. Registration of Medical Devices by Central Licensing Authority
(1) This Chapter shall be applicable to all devices notified under clause (b) of section 3 of the Act except the medical devices and devices specified in the Annexure of Eighth Schedule of these rules.
(2) The Medical devices referred in sub-rule (1) shall be registered with the Central Licensing Authority through an identified online portal established by the Central Drugs Standard Control Organisation for this purpose:
Provided that registration under this Chapter shall be on voluntary basis for a period of eighteen months from the commencement of this Chapter there after it shall be mandatory.
19B. Registration of Manufacturer of Medical Device
(1) The manufacturer of a medical device shall upload the information specified in sub rule
(2) relating to that medical device for registration on the “Online System for Medical Devices” established by the Central Drugs Standard Control Organisation for this purpose
19C. Registration number to be printed on labels of Medical devices Manufactured in India
After furnishing the above information on the “Online System for Medical Devices” established by Central Drugs Standard Control Organisation for this purpose by the applicant’s, registration number will be generated. Manufacturer shall mention the registration number on the label of the medical device
19D. Import of Medical Device
Any person who imports any medical device referred in rule 19A shall upload the following information relating to that medical device for registration on the “Online System for Medical Devices” established by the Central Drugs Standard Control Organisation for this purpose.
19E. Registration number to be printed on labels of Medical devices Imported in India
After furnishing the above information on the “Online System for Medical Devices” established by the Central Drugs Standard Control Organisation for this purpose by the applicant’s, registration number will be generated. Importer shall mention the registration number on the label of the medical device.
19F. Manufacturer/Importer Comply with Provisions of Central Licensing Authority
Central Licensing Authority may verify the documents at any point of time and investigate quality or safety related failure or complaints. The Central Licensing Authority may, after giving the registrant an opportunity to show cause as to why such an order should not be passed, by an order in writing stating the reasons therefor, cancel the registration number or suspend it for such period as the Central Licensing Authority thinks fit either wholly or in respect of any of the medical devices to which it relates, if in its opinion, the registrant has failed to comply with any provision of these rules.
Which is the approving authority?
CDSCO, the Central Licensing authority is the approving authority for the said applications.
Regulatory Documents:
An Application has to be submitted on SUGAM portal of Medical Devices for Non Regulatory Device. A comprehensive checklist of documents has been issued by the regulatory authority which needs to be submitted for processing and grant of relevant permissions.
- Name and Complete address of the Importer or Manufacturer
- Product Related Details :-
-
- Name and address of the Manufacturing site
- Generic Name and Brand name
- Model No.
- Intended use
- Class of Medical Device
- Material of Construction
- Shelf Life
- ISO 13485
- Dimension (if any)
- Sterile or Non Sterile
- Storage Conditions
- Pack sizes
3.Free sale certificate from country of origin. (Applicable to importers Only)
4.Undertaking duly signed by the manufacturer/importer stating that the information furnished by the applicant is true and authentic
Registration Number on Labels
As per RULE 19E of the Medical Devices (Amendment) Rules, 2020, An application filed to the Central Licensing authority on online SUGAM Portal , CDSCO Shall issue a Registration number to each Importer of Manufacturer which shall be mentioned on labels of Medical Devices.
Timelines
In the table below, we have listed the name of the authority who will issue the license to importers and manufacturers along with prescribed deadlines.
|
Class of medical device |
Licensing Authority |
Stipulated timeline for processing application |
Deadline for obtaining license |
|
Class A and B (import) |
DCGI |
Up to 9 months from the date of application |
August 11, 2022 |
|
Class C and D (import) |
DCGI |
Up to 9 months from the date of application |
August 11, 2023 |
|
Class A (manufacture) |
State-level Licensing Authority |
Up to 45 days from the date of application |
August 11, 2022 |
|
Class B (manufacture) |
State-level Licensing Authority |
Up to 140 days from the date of application |
August 11, 2022 |
|
Class C and D (manufacture) |
DCGI |
120 – 180 days (estimated) |
August 11, 2023 |
Voluntary Registration of Non Notified Medical Devices by 1 October 2021
Non Notified Devices or Devices Classified as Drugs for Manufacturer or Importer as per notification no.G.S.R. 102 (E) of CDSCO, must be Voluntarily registered by CDSCO within 18 months from 1st April 2020.The Said License Number must be Used on all Labels of the said Medical Devices.
Mandatory Registration of Class A and Class B Devices by 1 October 2022
Non Notified Devices or Devices Classified as Drugs for Manufacturer or Importer as per notification no.G.S.R. 102 (E) of CDSCO in Class A or Class B, must be approved via Registration certificate by CDSCO
Mandatory Registration of Class C and Class D Devices by 1 October 2023
Non Notified Devices or Devices Classified as Drugs for Manufacturer or Importer as per notification no.G.S.R. 102 (E) of CDSCO in Class C or Class D, must be approved via Registration certificate by CDSCO
WHY NKG FOR MEDICAL DEVICES REGISTRATION
Preparing regulatory documents is a time consuming and meticulous exercise. As an importer or overseas manufacturer , one is already engrossed in various business aspects prior to placing the product in India. If a mistake is made, it can lead to complete delay in regulatory gaps, business plan, overheads, financial planning issues as well as supply chain disruption.
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NKG has a Dedicated and Efficient team of experienced regulatory professionals who have Registered more than 2000 brands until now who can help you Plan your regulatory needs and smoothen the process for Regulatory approvals. Strategically located in New Delhi, the “regulatory “ capital of India, NKG makes a head start by following its unique time tested “Step-by- Step “ process that puts a lot of method in between the madness.
