Medical Devices (Amendment) Rules, 2020

The Medical Devices (Amendment) Rules, 2020, was effective from 01st April 2020. Introduction of a new chapter namely, Chapter IIIA, which deals with the registration of medical devices, and the modification of Eight Schedule, were the major amendments made to the existing rules. A major modification in the definition of the Medical devices was also effective from 01st April 2020. You can read more about the modified definition here. This modification in the definition of medical devices brings a host of new devices under the ambit of Medical Devices (Amendment) Rules, 2020.

The new definition shifts the earlier responsibility of determining a particular device as a medical device from the Central Government to the stakeholders i.e. manufacturer, importer, etc. This brings almost 2000 new devices, ranging from surgical masks to total artificial hearts, under the regulatory purview. In order to provide the stakeholders adequate time for registration, the Chapter IIIA was included and the Eighth Schedule was modified. Both of these provides a minimum of Eighteen months (18 months) exemption for such medical devices from all provisions of the Medical Devices (Amendment) Rules, 2020, from 01st April 2020.

Exemptions from the Provisions of Medical Device Rules

The Eighth Schedule of the Medical Devices (Amendment) Rules, 2020, deals with the exemption of medical devices. An annexure was added to the Eight Schedule, which contains a list of 37 devices. A few of such devices mentioned in the annexure was already (about 23) under existing regulation and the rest was effective from the date mentioned in the annexure. The table can be found at the end of this blog. Also a exemption was added to the table in the eighth schedule under serial number 7. It exempts all the medical devices except those mentioned in the annexure to the eighth schedule from all the provisions of the rules subject to the condition that such medical devices shall be registered under CHAPTER IIIA of these rules. The exemption shall cease after a period of thirty months for Class A and Class B and after a period of forty two months for Class C and Class D devices, respectively, from 01st April, 2020.

The Chapter IIIA provides for the registration of all medical devices, except those specified in the Annexure of Eighth Schedule, by the manufacturers and importers to the Central Licensing Authority through an online portal of the Central Drugs Standard Control Organisation established for this purpose. After the registration, a registration number will be provided which should be mentioned on the label of the device.

The registration is however voluntary basis for a period of eighteen months from 01st April 2020, after which it becomes mandatory. For the registration of medical devices by the manufacturer or importer, an ISO 13485 certificate for such devices from the National Accreditation Board for Certification Bodies or International Accreditation Forum, is mandatory. The Central Licensing Authority may verify the documents and investigate quality or safety related failure or complaints. If the registrant fails to comply with the provisions of the rules, the Central Licensing Authority may suspend or cancel his registration after giving him a show cause notice and an opportunity to explain his side.

Salient features of these rules

Based on the parameters specified in the First Schedule, the Central Licensing Authority alone can classify the medical devices into one of the four categories, namely Class A, Class B, Class C and Class D. More details about the classification can be found here. So unless the Central Licensing Authority classifies and publishes all the medical devices, it would be impossible for the manufacturer or importer to complete registration, since they have to mention the same in the details of the medical device. It remains to be seen whether the manufacturer can be classify the medical device, as in other countries, and complete the registration. In most countries, it is the responsibility of the manufacturer or importers to classify the device based on the risk and submit the appropriate application.

Annexure

(See rule 19A)

S.NO	Name of the device
1	Disposable Hypodermic Syringes
2	Disposable Hypodermic Needles
3	Disposable Perfusion Sets
4	Substances used for in vitro diagnosis including Blood Grouping Sera
5	Cardiac Stents
6	Drug Eluting Stents
7	Catheters
8	Intra Ocular Lenses
9	I.V. Cannulae
10	Bone Cements
11	Heart Valves
12	Scalp Vein Set
13	Orthopedic Implants
14	Internal Prosthetic Replacements
15	Ablation Devices
16	Ligatures, Sutures and Staplers
17	Intra Uterine Devices (Cu-T)
18	Condoms
19	Tubal Rings
20	Surgical Dressings
21	Umbilical tapes
22	Blood/Blood Component Bags
23	Organ Preservative Solution*
24	Nebulizer (effective from 1 Jan.2021)
25	Blood Pressure Monitoring Device(effective from 1 Jan.2021)
26	Glucometer (effective from 1 Jan.2021)
27	Digital Thermometer (effective from 1 Jan.2021)
28	All implantable medical devices Equipment (effective from 1, April,2021)
29	CT Scan Equipment (effective from 1, April,2021)
30	MRI Equipment (effective from 1, April,2021)
31	Defibrillators (effective from 1, April,2021)
32	PET Equipment(effective from 1, April,2021)
33	X-Ray Machine (effective from 1, April,2021)
34	Dialysis Machine (effective from 1, April,2021)
35	Bone marrow cell separator (effective from 1, April,2021)
36	Disinfectants and insecticide specified in Medical Devices Rules, 2017
37	Ultrasound equipment (effective from 1, November, 2020)