In India, depending on the class, the medical devices are regulated by Central Licensing Authority and State Licensing Authority
Central Licensing Authority
The central licensing authority is the competent authority for the enforcement of these rules in relation to:
- Import of all classes of medical devices
- Manufacture of Class C and D medical devices
- Clinical investigation and approval of medical devices
- Clinical performance evaluation and approval of new in vitro diagnostic medical devices, and
- Co-ordination with state licensing authorities
The Central licensing authority, with prior approval of the Central Government, may delegate his powers to any other officer in the CDSCO not below the rank of the Assistant Drug Controller.
State Licensing Authority
The State licensing authority is the competent authority for the enforcement of these rules in relation to:
- Manufacture for sale or distribution of Class A or Class B medical devices.
- Sale, stock, exhibit or offer for sale or distribution of medical devices of all classes.
The State licensing authority, with prior approval of the State Government, may delegate his powers to any officer under his control.
Any officer not below the rank of the Assistant Drug Controller shall be the controlling officer and can give instructions to his subordinate officer to exercise powers and functions under these rules for areas and purposes specified by an order.
National Accreditation Body
Any institute, firm or a Government aided or Government organization which fulfils the specified criteria may be designated as the National Accreditation Body by notification. Until the time such body is notified, the National Accreditation Board for Certification Bodies will act as the National Accreditation Body for the purposes of accrediting Notified Bodies.
National Accreditation Body should not act as notified bodies. They should lay down the standards, norms, procedures and perform conformance assessment activities for accrediting Notified bodies. They should carry out the assessment of the entities which have applied for accreditation as Notified Bodies and issue the certificate for the specified categories of standards for which the entity has been assessed. After accreditation they should periodically audit the Notified Bodies for the conformance with the rules.
Notified Body
Any institute, organization or body corporate may apply to the National Accreditation Body in prescribed forms for functioning as Notified Body. After accreditation, they should register with the Central Licensing Authority, if they wish to audit the Class A and Class B Medical Devices Manufacturing sites as per the direction of the state licensing authority. After two years of auditing experience as notified body, they may apply to the Central Licensing Authority for carrying out the audit of Class C and Class D medical Devices.
The application has to made in Form MD-1, through online portal with a fee prescribed in the second schedule along with the documents specified in Part I of the Third Schedule. The Central Licensing Authority will then issue a registration certificate in Form MD-2. If the requirement for registration is not complied, the Central Licensing Authority may reject the application by giving the reason. In such cases, the applicant may appeal the Central Government within forty five days and the Central Government will dispose the appeal within sixty days. The Registration Certificate shall remain Valid in perpetuity unless it is suspended or cancelled, provided the Notified Body pays the registration retention fees as specified in the Second Schedule every five years on or before the due date. The late fee is two percent of the retention fee for each month and should be paid within ninety days along with retention fee, failing which the registration certificate is deemed to have cancelled.
The notified body shall perform the functions as specified in They may carry out such functions either by itself or by any qualified persons on its behalf in accordance with the procedure specified in Part II of the third schedule. The notified body may charge the fee from the applicant as determined by the Central Government. When directed by the State Licensing Authority, the Notified Body may audit the manufacturing sites of Class A and Class B Medical Devices to verify the conformance with the Quality Management System and other applicable standards as specified under these rules. If the notified body fails to comply with any provisions of these rules, the Central Licensing Authority after giving a show cause may cancel or suspend the license. The notified body may appeal against the order within thirty days to the Central Government. If the accreditation of the notified body with the National Accreditation Body is expired then the registration of notified body is deemed to have cancelled.
Medical Device Testing Officer
The Central Government may designate a Government Analyst appointed under Section 20 of the Act as Medical Device Testing Officer.
Medical Device Officer
The Central Government or, as the case may be, the State Government, may designate an Inspector appointed under section 21 of the Act as Medical Device Officer.
Central medical device testing laboratory
The Central Government may notify and establish the Central medical devices testing laboratory for the purpose of:
- testing and evaluation of medical devices; or
- functioning as an appellate laboratory; or
- to carry out any other function as may be specifically assigned to it.
The Central Government may designate any laboratory, duly accredited by the National Accreditation Body for Testing and Calibration Laboratories, having facility for carrying out test and evaluation of medical devices as central medical devices testing laboratory for the purposes mentioned above.