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Regulatory Information

The regulatory information outlined in this document are primarily drawn up in accordance to the legal requirements of the Cosmetics, Devices and Drugs Act No. 27 of 1980 and Cosmetics, Devices and Drugs  Regulations – The gazette of the Democratic Socialist Republic of Sri Lanka (Extraordinary) No. 378/3 of 1985.

Defined in the Act, “Device” includes;

any article, instrument, apparatus or contrivance, including any component, part of accessory thereof; manufactured or sold for use in

  1. the  diagnosis, treatment, mitigation or prevention  of disease, disorder or abnormal physical state or the symptoms  thereof, in man or animal,
  2. restoring, correcting or modifying a body function or the  body  structure of man or animal,
  3. the diagnosis of pregnancy in human beings or animals, or
  4. the care of human beings or animals during pregnancy and at and after birth of the off-spring, including care of the off-spring and includes a contraceptive device but does not include a drug;

Provisions Under The Act

All devices, manufactured, imported, sold and distributed and offered for sale in Sri Lanka should be registered under the provisions of the Act.

Device manufacturers and importers within or outside Sri Lanka intending to market their products in Sri Lanka should register their products.

  • The application for registration shall be made along with the required documents in Schedule I, Form A (Regulations 4(3)) of Cosmetics, Devices and Drugs  Regulations (The gazette of the Democratic Socialist Republic of Sri Lanka (Extraordinary) No. 378/3 of 1985.)
  • The documents required for registration should be in English and submitted in a hard file cover
  • The documents for registration are processed only if they are complete and as per specifications.
  • Separate applications should be made in respect of each device to be registered. [i.e. products containing different specifications, different brands]
  • Products of foreign manufacturers should be submitted through a local agent

Pre-requisites for registration of a device

  • Obtaining Sample Import Licence
    by submitting
    • a copy of business registration certificate of the applicant[should indicate the board of directors, Secretarial board (BR 1)]
    • letter of authorization from the manufacturer appointing the local agent

Data Requirements

All the certificates for registration of device should be signed by an Authorized Officer.

General Documents/ Requirements

  1. Schedule I, Form A & Form B
  2. Copy of sample import licence
  3. Free sale certificate
  4. Fully packed samples (two) of devices in the form that is intended to be marketed
    [as a registration sample (including Lot no., Man. Date, Exp.date, Manufacturer’s & Importers details and when required sufficient quantity for analysis)]
  5. List of countries which the device is approved or registered for sale with copies of registration certificates

Technical Documents

  1. Label/ catalogue/ User Manual
  2. Patient Information Leaflet

(i.e. THE APPLICANT FOR PRODUCT REGISTRATION/ LOCAL AGENT)

The applicant should be responsible for the product and all information supplied in support of his application for registration of the product.

He should be responsible for updating any information relevant to the product/ application. The CDDRA should be informed in a timely manner any change in product information during the course of evaluation, and after product registration, especially if the information pertains to rejection/ withdrawal, additional data on product quality, effectiveness and safety or current Good Manufacturing Practice (cGMP) compliance of the manufacturers.

He should provide additional documents for renewal of registration, six months before the expiry of certificate of registration.

The marketing authorization holder must assume responsibility for the quality, safety and effectiveness of his products.

The fee for registration of device are specified in Schedule II of the regulations and last amendment is the gazette notification no. 1601/15, May, 2009 and will be subjected to revision from time to time.

Processing Fee:

Processing fee for the registration of a Device is Rs. 3000 + VAT

Registration Fee:

The registration fee per product should be paid  prior to the issuance of registration certificate.

  1. Full registration for an imported device – Rs. 7,500 + VAT
  2. Full Registration for a locally manufactured product – Rs. 5,000 + VAT
  3. Provisional Registration for an imported drug – Rs. 2,000 + VAT
  4. Provisional Registration for a locally manufactured product – Rs. 1,000  + VAT
  5. Renewal of a certificate of registration/ re-registration (PR/ FR) – Rs. 5,000 + VAT
  6. In case if the imported need a duplicate copy of the certificate, Rs. 1,000 + VAT
    per product should be paid and it will bear the words "duplicate copy”.
  7. Any amended copy of a certificate Rs.1,000 + VAT.

If the market authorization holder fails to comply with the conditions of registration of that device, the authority may remove the name of the device from the register of device after seeking the opinion from the Medical Device Evaluation Sub-Committee.

Licence to import devices

  1. Licence to import registered devices – Rs. 3,000 + VAT
  2. Licence to import samples for test, examination fee – Rs. 2,000 + VAT
  3. Amended copy of the certificate of import licence – Rs. 1,000 + VAT

Licence fee to Manufacture devices

  • Licence to Manufacture devices- Rs. 1,000 + VAT

Mode of Payment

The payment should be made to the shroff counter of the Ministry of Health.

Any payment made is not refundable once a application has been submitted and payment confirmed. Applications without the correct fees will not be entertained.

Multiple Applications

A separate application is required for each product i.e. product containing different specifications or by a different manufacturer shall require a separate application for product registration.

Decisions of the Medical Device Evaluation Sub-Committee (MDESC)

A regulatory decision is made based on the outcome of the evaluation of the submitted documentation. The evaluation may be done by both external expertise and internal evaluators. The decision is submitted to the Medical Device Evaluation Sub-Committee (MDESC) for further opinion. The MDESC may, in the interest of public safety, reject the registration of any product. The final decision will be notified to the applicant

Product Identification Number

A identification number will be allocated by the authority when a product application is deemed to have satisfied the registration requirements. The identification number is specific for the product registered with the name, identity, characteristics, origin (manufacturer) and market authorization holder. It may NOT be used for any other product.

The following prefixe is used before the product identification number.

DVR - Registration of new device

DVR - RR - Re Registration of registered device

Award of Registration Certificate

The registration certificate will be issued format given in Schedule IV, Form A (Regulation 5(2)) of regulations.

The registration certificate will be issued within 30 working days from the date of receipt of complete documents unless otherwise a longer period is required in case of which the party will be notified.

Validity Period of Registration

The Full Registration of a product is valid for a period of five years and is specified in the certificate.

The Provisional Registration of a product is valid for a period of one year and is specified in the certificate.

When additional data are requested, the applicant will have to furnish additional information requested by the authority within 3 months to facilitate further evaluation.

If the product is Rejected, the market authorization holder will be able to appeal for registration

Renewal of Registration

Application for renewal should be made before six months from the date of expiry of registration.

A grace period will extend until the decision is given to the application for renewal.

If the requirement for registration are not satisfactory the application will be rejected completely.

Cancellation of Registration

The authority may cancel the registration of any product if:

  1. Any of the conditions of registration of the product has been contravened or changed,
  2. Any complaints on quality failure of product have been reported from National Pharmacovigilance Centre or any other national or international sources or customers.
  3. The information which was furnished at the time of application is later found to be false or insufficient.
  4. For any other matters as specified by the authority at the time of cancellation.

Any applicant/ market authorization holder aggrieved by the decisions of the CDDA may make a written appeal to the CDDA/MDESC. All notice of appeals must be made within thirty days from the date of the CDDA notification.

Change in Particulars of Registered Products

Any change in product name, product specifications, packaging, indications, contents of product label, package insert, or product literature, or any relevant particulars of the registered product should not be made with the prior approval of the authority.

The registration of the product maybe cancelled if changes are made without the prior approval of the authority.

Any change of product which affects qulity,safety & efficacy of the product should require a new application for registration.

Criteria for Registration

A product will be registered only if it satisfies all requirements of the CDDA, especially with respect of safety, quality and effectiveness of the product.

Other criteria that may be taken into consideration include:

  1. Necessity of the product as a medical device in patient use
  2. Product advantage

Product Label

The following information should be present on the labeling of the product.

Outer label/ Secondary packaging material

  • Name of product [Approved name and brand name (if any)]
  • Name and address of the manufacturer/ marketing authorization
  • Whether the product is sterile or not and mode of sterilization
  • Storage conditions specifying the temperature
  • Manufacturing date, Expiry date and Lot no.

Product Information Leaflet/ Patient Information Leaflet

Product information leaflet may be attached with certain products to acknowledge the user indicating the way of handling the product.