Medical Devices Certification

While importing any medical device under Class A, Class B, Class C & Class D requires the certification from the Indian Government

Medical Certification

Medical Devices have always been an object of concern and regulation by the Indian Government. With advancing medical technology and the exponentially rising need of medical devices in the country, new reforms and rules have come into effect. Medical Devices Rules’2017 (MDR) are governed by respective central and state regulatory authorities. Regulatory bodies classify medical devices based upon the associated risk and have defined relatively easy procedures for license applications. Similarly, rules and guidelines have been promulgated by the government for the import of medical devices. Whereby, all one need is to have an Authorized Indian Representative (AIR) to apply for the license. With the reformative intervention and efforts of the government such as the SUGAM portal, obtaining medical device licenses is now an expedite procedure For all the medical devices along with in Vitro medical devices, being imported or manufactured, requires the permission from CDSCO. Here, the approval is given by CDSCO’s State Licensing Authority (SLA) or the Central Licensing Authority (CLA).

Notified devices under the regulation

Device Name	Device Name
1-Disposable Hypodermic Syringes	19- Condoms
2-Disposable Hypodermic Needles	20- Tubal Rings
3-Disposable Perfusion Sets	21- Surgical Dressing
4-In vitro Diagonostic for HIV, HbsAg & HCV	22- Umbilical Tapes
5-Cardiac Stents	23- Blood/ Blood Component Bags
6-Drug Eluting Stents	24- Disinfectant.
7-Catheters	25- Nebulizer
8-Intra Ocular Lenses	26- Blood pressure monitoring device
9-I.V. Cannulae	27- Digital Thermometer
10-Bone Cements	28-Glucometer
11-Heart Valves	29- All Implantable Medical Device
12-Scalp Vein Set	30- MRI Equipment
13-Orthopedic Implants	31- CT Scan Equipment
14-Internal Prosthetic Replacements	32-Dialysis Machine
15-Ablation Devices	33- PET Equipment
16- Blood Grouping Sera and Substances for In Vitro Diagnosis	34- X Ray Machine
17- Ligatures, Sutures and Staplers	35-Defibrillator
18- Intra Uterine Devices (Cu -T)	36-Bone Merrow Cell Seperator
	37-Ultrasound Equipment

Application Process

Risk Based Classification

Medical devices have been classified into A, B, C and D categories where the risk factor involved increases from A to D. Low-risk devices include equipment like thermometers whereas high-risk devices include pacemakers, heart valves and others. The devices are further classified as surgical or non-surgical devices based upon their invasiveness. License for class A devices is easy to obtain as compared to class D devices.

Certificate Type & the applicable authorities

Device Class Activity	Class A	Class B	Class C	Class D
Import	CLA	CLA	CLA	CLA
Manufacture	SLA	SLA	CLA	CLA
Permission to Conduct Clinical Investigation		Permission from CLA
QMS Verification	Notified Body registered with CLA	Notified Body registered with CLA	CLA	CLA

Applicable Licenses

SN	Forms	Application Type
1	Form MD-3	Application for Grant of License to Manufacture for Sale and Distribution of Class A or Class B medical device
2	Form MD-4	Application for Grant of Loan License to Manufacture for Sale or for Distribution of Class A or Class B medical device
3	Form MD-5	License to Manufacture for Sale or for Distribution of Class A or Class B Medical Device
4	Form MD-6	Loan License to Manufacture for Sale or for Distribution of Class A or Class B medical device
5	Form MD-7	Application for Grant of License to Manufacture for Sale or for Distribution of Class C or Class D
6	Form MD-8	Application for Grant of Loan License to Manufacture for Sale or for Distribution of Class C or Class D
7	Form MD-9	License to Manufacture for Sale or for Distribution of Class C or Class D
8	Form MD-10	Loan License to Manufacture for Sale or for Distribution of Class C or Class D medical device
9	Form MD-14	Application for issue of import licence to import medical device
10	Form MD-15	Licence to Import Medical Device
11	Form MD-41	Application for Grant of Registration certificate to sell, stock, exhibit or offer for sale.
12	Form MD-42	Registration Certificate to sell, stock, exhibit or offer for sale.

Classification of Applicant & required license

Importer

Indian Manufacturer

Important Points

If a Manufacturer or Authorized agent, considers that a medical device which has been imported, manufactured, sold or distributed , is likely to be unsafe, such manufacturer or authorized agent shall immediately initiate procedure to withdraw the medical device in question from the market and immediate inform the competent authority.
The Medical device shall be registered with the Central licensing authority through an identified Online portal established by the Central Drugs standard Control Organization.
Applicant’s Registration Number will be generated by CDSCO, Manufacturer / Importer shall mention the registration Number on the label of the Medical Device.