Draft Amendment Rules for regulation of medical devices in India

India is one of the largest market in the Asia for medical devices. A report compiled by India Brand Equity Foundation in May 2019, a trust established by the Department of Commerce, Ministry of Commerce and Industry, Government of India, estimated the Healthcare market in India to reach US$ 372 billion by 2022, while medical devices market is expected to cross US$ 11 billion by 2022. It is estimated that 80% of the medical devices are imported in India. Thus a comprehensive law to regulate quality of devices being imported is needed.

With the vision of regulating the manufacturing and importing activities of the medical devices in India under common standards, the Ministry of Health and Family welfare with consultation of Drugs Technical Advisory Board (DTAB) has released draft rules for the amendments in Medical Devices Rules, 2017. These draft rules will now be finalized after considering the suggestions received from the stakeholder/s.

The notification by the Ministry specifies that all the following devices intended for use in human being or animal will be considered as Drugs:

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 purpose of –

  1. diagnosis, prevention, monitoring, treatment or alleviation of any disease or disorder;
  2. diagnosis, monitoring, treatment, alleviation or assistance for, any inquiry or disability;
  3. investigation, replacement or modification or support of the anatomy or of a physiological process;
  4. supporting or sustaining life;
  5. disinfection of medical devices; and
  6. control of conception.

The draft rule proposes to insert Chapter IIIA in Medical Devices Rules, 2017 for registration of Medical devices by manufacturers or importers through an “Online System for Medical Devices” established by Central Drugs Standard Control Organization. Initially the registration shall be on voluntary basis for a period of 18 months and thereafter the registration will be a mandatory requirement. This chapter will be applicable to all devices included in the Medical Devices Rules, 2017 except the exemption in the eighth schedule.

Process of Registration and the required Information

  • Manufacturer:

The manufacturer will have to provide following information for the registration:

  1. name & address of the company or firm or any other entity manufacturing the medical device along with name and address of manufacturing site of medical device;
  2. details of medical devices such as generic name, model no, intended use, class of medical device, material of construction, dimension (if any), shelf life, sterile or non sterile, brand name (if registered under the Trade Marks Act, 1999;
  3. certificate of compliance with respect to ISO 13485 standard accredited by National Accreditation Board for Certification Bodies or International Accreditation Forum in respect of such medical device;
  4. undertaking duly signed by the manufacturer stating that the information furnished by the applicant is true and authentic.
  • Importer:

The importer will have to provide following information for the registration:

  1. name of the company or firm or any other entity importing the medical device and specification and standards of that medical device;
  2. free sale certificate from country of origin along with details of medical device; certificate of compliance and undertaking duly signed.

After furnishing the details, a registration number will be generated and manufacturer/importer, as the case may be, shall mention the registration number on the label of the medical device.

Our Comments:

With a large percentage of medical devices being imported into India, the industry needs both regulatory regime and patient safety norms. The current regulations only lay down a regulatory framework but do not address patient safety for which a separate and comprehensive law is needed. The other question often raised is whether equating medical devices with drugs is the right approach? The medical devices are akin to engineering items. Therefore, a clear framework and a separate body to regulate this sector will go a long way in attracting foreign investment.  For now, the draft rules are to be taken on a positive note with a broader vision of harmonizing the regulation of medical devices.

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