Regulatory Compliances of Medical Devices as per New Amendment – Medical Device Regulation (MDR) Act (MDR, April, 2020)

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Dr. Prangya P.Tripathy, PhD; from Neucrad Health desk; August 11, 2020

The quality standards and safety of medical devices in India are regulated by the law called The Drugs and Cosmetics Act, 1940 (“DCA”). The DCA scope is restricted to only “notified medical devices” that are notified by the Government from time to time as “drugs”. The Medical Devices Regulations, 2017 (“MDR”) have been framed under DCA. In accordance to these rules, inclusive quality requirements must be followed by all manufacturers, importers sellers of notified medical devices. All medical devices entering into India must be in conformity with the Indian Medical Device Regulations as lay down by the Central Drugs Standard Control Organization (CDSCO). The MDR has been amended recently with effect from April 1, 2020 and will now applicable to all medical devices (Refer Definition below). Prior to the amendment, only 37 categories of medical devices were under regulation act. The importers and manufacturers of the medical devices have to be certified with ISO-13485 (Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes) in order to obtain the registration certificate.

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About MDR Amendment, April, 2020

Definition:   “ As per new notification, effective from April 1, 2020, under the DCA and MDR, the medical devices that fall under the following definition will be regulated as “drug”: “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”. All these are referred as “Newly notified Medical Devices” in this article.

The MDR Amendment (April, 2020) introduces two major changes in MDR.

  1. Introduction of a new chapter for registration of Newly Notified Medical Devices by their respective manufacturers and importers.
  2. Exemption from the requirement of registration of the 37 categories of already regulated or notified medical devices introduced by the new chapter.

Registration Requirement

The registration of the newly notified medical devices (manufacturers and importers) with the Drugs Controller General of India (“DCGI”) is mandatory now before the deadline i.e. October 1, 2021.  However, some medical devices which are already regulated or have been notified to be regulated are exempted from the requirement of registration (e,g, 37 items which are existed before, refer Table 2). The Government eases the registration process and there is no need of appointing a full-fledged marketing registration or authorization agent now. Any importer or manufacturer of Newly Notified Medical Devices will be able to obtain registration online by the submission of the following information.

  1. Name of the company or firm or any other entity.
  2. Name and address of manufacturing site (for devices manufactured in India only)
  3. Specification and standards of medical device (for imported devices only)
  4. Details of medical devices (Generic Name, Model No., Intended Use, Class of Medical Device, Material of Construction, Dimensions (if applicable), Shelf Life, Sterile or Non-sterile status, Brand name only if registered under India’s trade mark law)
  5. Certificate of compliance with respect to ISO 13485 standard accredited by National Accreditation Board for Certification Bodies or International Accreditation Forum in respect to such medical devices
  6. Free sale certificate from the country of origin (for imported devices only)
  7. A duly signed undertaking stating that the information furnished by the applicant is true and authentic.

After online submission of the documents, the registration number is issued. The registration will be complete only upon successful generation of a registration number. The registration deadline declaration for the newly notified medical devices in the new amendment is October 1, 2021. It is not possible for the importer or manufacturer to market and sell its newly notified medical devices in India until registration is obtained. However, there are 37 categories of medical devices regulated or notified prior to February 11, 2020 (Table 2) andare exempted from the requirement to obtain registration as per new rule and thus can continue to carry out their businesses on the strength of the license issued by appropriate licensing authority.

Label Declaration of Registration Number

Every manufacturer and importer who obtains a registration number for its medical device will have to display the registration number on its label. However there is no relation between the declaration of registration number with the deadline for registration (October 1, 2021). Unless otherwise ordered by DCGI, the labeling is an immediate requirement and will generate from the time of the registration number is issued.

Implementation of ISO-13485 for Registration Requirement in Newly Notified Devices

For registration of Newly Notified Medical Device, a certificate of compliance with ISO-13485 (Medical DevicesQuality Management Systems – Requirements for Regulatory Purposes) is compulsory. The requirements of ISO 13485 should be met at all times by a registered importer or manufacturer of a medical device. ISO 13485 in general is responsible for creation, documentation and implementation of a quality management system which is to be supplemented by an independent audit from time to time. After successful registration of its medical devices, an importer or manufacturer will have to strictly conform to its documented quality management system (QMS). Any false implementation of the QMS by the manufacturer or importer will lead the DCGI to suspend or cancel the registration of the medical device any time. 

Requirement of registration for supply chain

Registration requirement for the supply chain will not be required to sell registered medical devices.

Is there any Relaxation to obtain Registration and License as per New Amendment

Yes, to transition into the regulatory framework and to obtain ISO 13485 certification, if not already obtained, the government has given time to the medical device industry. The relaxation requirement time for newly notified medical devices are explained below (Table 1).

Exemption for devices regulated or proposed to be regulated but notified before February 11, 2020

The 37 categories of medical devices regulated or notified prior to the date of MDR Amendment i.e. February 11, 2020, will not be affected by the new MDR Amendment and therefore will not be required to obtain registration (Table 2). However, these devices and their importers, manufactures and the entire supply chain will have to obtain a license and observe other compliances stipulated under new MDR at all times.

What happened if Registration or License cannot be Obtained in Stipulated Time                       

If any manufacturer or importer of newly notified medical device is failed to obtain registration by October 1, 2021, then it will be ceased by the DCGI until the registration is obtained. Now, under the Legal Metrology (Packaged Commodity) Rules, 2011, for all medical devices (whether regulated or unregulated) the importer or the manufacturer is required to declare the date of import or the date of manufacturing of the medical device on its label. Thus all the devices manufactured or imported on or after October 1, 2021 must be labeled with a DCGI registration number. If it fails to show the registration number, then the action will be taken by DCGI or appropriate state level licensing authorities. Criminal prosecution resulting in imprisonment and fine can be imposed if any violation of MDR is noticed. Any stockpile of medical device that is sold without registration or license could also be seized.

Concluding Remarks

The new rules MDR 2020 ensures that every medical device either manufactured in India or imported, have quality assurance before they can be distributed / sold in the market. The Government has also given sufficient time for the industry to adopt ISO 13485 and quality management systems in place. The timeline for obtaining license and registration prescribed for medical devices and as well as previously unregulated medical devices shall provide a breather for pharmaceutical companies. Now, the responsibility is on the industry to do its part and reinforce the belief of the Indian consumer and the international community in the quality and safety of medical devices sold in India.

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  1. S.O. 648(E) dated 11.02.2020_ Medical Device Definition
  2. G.S.R. 102(E)_dated 11.02.2020_ Registration of certain medical devices
  3. Amendment inserting Annexure to Eight Schedule under Rule 19A
  4. Section 3 (b) (iv), Drugs and Cosmetics Act, 1940
  5. Rule 19 E, The Medical Devices (Amendment) Rules, 2020
  6. Proviso to Rule 19 A (2), the Medical Devices (Amendment) Rules, 2020
  7. Amendment inserting S No. 7 to Eighth Schedule of the Medical Devices Rule, 2017
  8. Rule 85 of the Drugs and Cosmetics Rules, 1945
  9. Section 27 (b) (ii) of the Drugs and Cosmetics Act, 1940