Medical Devices REGULATORY SERVICES
Permission to Import, Stock ,or Sell Medical Devices MD 42
The Ministry of Health and Family Welfare, Government of India has published the 5th Amendment of Medical Device Rule vide General Statutory Rule (G.S.R.) 754(E) on 30th September 2022. This Rule has made provision for Registration Certificate to sell, stock, exhibit, or offer for sale or distribute a medical device including In-Vitro diagnostic device.
It means if you are a retailer, wholesaler, or stockist of medical devices including IVDs, you must get a registration certificate from the state licensing authority on Form MD-42. The MD 42 Registration Certificate is mandatory from 30 September 2022.
“What is MD 41?
MD 41 is the Application Form to be submitted by the retailer, wholesaler, or stockiest to the State Licensing Authority to get the Medical Device Registration Certificate on form MD 42.
What is MD 42?
MD 42 is the Legal Medical Device Registration Certificate issued by the State Licensing Authority to the retailer, wholesaler, or stockiest to sell, stock, exhibit, or offer for sale or distribute a medical device including In-Vitro diagnostic device.”
Which Documents Are Required to Apply for MD 42 Registration Certificate?
- Receipt of fees
- Self-Certification of compliance to Good Distribution Practice.
- Identification proof of the applicant like Aadhar Card or PAN Card
- Rent Agreement or Sale Deed of the premises.
- Certificate and Experience Letter of the Competent Technical Staff
- A brief description on other activities carried out by applicant.
- An undertaking for compliance with the storage requirements of medical devices.
Who Qualifies as Competent Technical Staff for MD 42 Registration Certificate?
- Who holds a degree from a recognized University/Institution; or
- Who is a registered pharmacist; or
- Who has passed intermediate examination with one-year experience in dealing with sale of medical devices;
The Applicant must appoint a Competent Technical Staff to direct and supervise the sales activity of medical devices. The Competent Technical Staff must possess the above educational qualification and experience.
How to Get MD 42 Registration Certificate in India
- The applicant should fill the application form MD 41 on the online CDSCO Sugam Portal.
- Upload all the required documents.
- Pay the prescribed fee of Rs. 3000/-
- Submit the Application to the Licensing Authority.
- After scrutiny, the State Licensing Authority shall grant the MD 42 Registration Certificate.
- The Authority may conduct an inspection at our premises to verify all the compliance of the rule.x
SALES LICENSE REGISTRATION CERTIFICATE CONDITIONS
- The registration certificate granted under rule 87A shall be displayed at a prominent place in the premises visible to the public.
- The registration certificate holder shallprovide adequate space and proper storage condition for storage of the medical devices.
- The registration certificate holder shall maintain requisite temperature and lighting as per requirements of such medical devices.
- The medical devices shall be purchased only from importer or licensed manufactureror registered/licensed entity.
- Separate records, in the form of invoice or register or electronic details including software of purchases and sales of medical devices must be retained. These records must show the names and quantities of such medical devices, names and addresses of the manufacturers or importers, batch number or lot number and expiry date (if applicable) shall be maintained.
- The records referred to in sub-rule (5) shall be open to inspection by a Medical Device Officer appointed under the sub-rule (2) of rule 18, who may, if necessary, make enquiries about purchases and sale of the medical devices and may also take samples for testing.
- All registers and records mentioned under these rules, shall be preserved for a period of not less than two years from the last entry, therein.
- The registration certificate holder shall maintain an inspection book in Form MD-43to enable the Medical Devices Officer to record his observations and defects noticed.
NKG experts are well versed with the New Medical Device rules and guidelines and have helped clients smoothen the regulatory processes and get approvals and permissions.
Application Form :
The below table suggests that application form , approval form, fee structure based on the risk class of products.
|
Application Form |
Approval Form |
Risk/Class A,B,C,D |
Fees |
Licensing Authority |
|
MD 41- Application for grant of permission to sell, stock, exhibit or offer for sale or distribute a medical device including in vitro diagnostic medical device |
MD 42- Permission to the retailer, wholesaler, or stockiest to sell, stock, exhibit, or offer for sale or distribute a medical device including In-Vitro diagnostic device. |
NONE |
Rs-3000/- |
STATE |
why nkg for Medical Services
NKG has a Dedicated and Efficient team of experienced regulatory professionals who can help you Plan your regulatory needs and smoothen the process for Regulatory approvals. Strategically located in New Delhi, the “regulatory “ capital of India, NKG makes a head start by providing clear and easily understandable requirements.
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NKG has a Dedicated and Efficient team of experienced regulatory professionals who have Registered more than 2000 brands until now who can help you Plan your regulatory needs and smoothen the process for Regulatory approvals. Strategically located in New Delhi, the “regulatory “ capital of India, NKG makes a head start by following its unique time tested “Step-by- Step “ process that puts a lot of method in between the madness.
