India publishes amendment rules for Medical Devices Rules

On February 11, 2020, India’s Ministry of Health and Family Welfare published the “Medical Devices (Amendment) Rules, 2020” for partial amendments to “Medical Devices Rules, 2017”. The draft was announced on October 18, 2019 in the Official Gazette and open for public comments. This rule will come into force with effect from April 1, 2020.

 

Added “Chapter IIIA Registration of Certain Medical Devices”

  • This Chapter shall be applicable to all devices notified under clause (b) of section 3 of Drugs and Cosmetics Act except the medical devices and devices specified in the Annexure of Eighth Schedule (Art. 19A.(1)).
  • The medical devices covered shall be registered with the Central Licensing Authority through an online portal established by the Central Drugs Standard Control Organisation (Art. 19A.(2)).The registration is on voluntary basis for a period of eighteen months from the commencement of this Chapter and after that it shall be mandatory.
  • The manufacturer of a medical device shall upload the following information on the “Online System for Medical Devices” (Art.19B).
    1. Name and address of the company or any other entity manufacturing the medical device along with name and address of manufacturing site.
    2. Details of medical device such as Generic name, Model No., Intended use, etc.
    3. Certificate of compliance with respect to ISO 13485
    4. Undertaking duly signed by the manufacturer stating that the information furnished by the applicant is true and authentic
  • Any person who imports any medical device referred in rule 19A shall upload the information such as free sale certificate from country of origin for registration on the online system.

 

Added S.N. 7 to the Annexure of Eight Schedule

7 All medical devices except those specified in the Annexure of Eighth Schedule. All the provisions of these rules subject to the condition that such medical devices shall be registered under CHAPTER IIIA of these rules:

Provided that such exemption shall cease after a period of thirty months for low risk – Class A and low moderate risk – Class B and after a period of forty-two months for moderate high risk – Class C and high risk – Class D devices, respectively from the date of this notification.

The “Medical Devices (Amendment) Rules, 2020” can be downloaded from the following URL (in Hindi and English)
http://egazette.nic.in/WriteReadData/2020/216075.pdf