Chapter 1 Pakistani DRAP administration information abstract

1. Administration and Abstract

The main administrations for the medical device market in Pakistan are the Drug Regulatory Authority of Pakistan (DRAP) and the Ministry of National Health Services Regulations and Coordination (MONHSR&C). They are responsible for the registration, manufacture, import and export supervision of medical equipment and in vitro diagnostic products.

2. Administrative Regulation

Medical Devices Rule 2017

3. Risk Level Classification of Medical Device and IVD Products

The 2017 Medical Device Rules classifies medical devices into four categories (A, B, C, and D) based on risk-based classification rules.

4. Registration Language

English.

Chapter 2 Registration Flow、Cycle & Official Fee

1. Registration Flow

2. Official Fee

Chapter 3 FAQ

Q: Whether the proof of country of origin is mandatory for medical device registration in Pakistan?

A: Yes, it is mandatory.

Q: How long is the certificate valid?

A: The certificate is valid for five years.

Q: How to change the information on the certificate of registration?

A: Any change to information in the Certificate of registration (e.g. product specifications, production sites, etc.) should be made to MDB in advance and approved. The registered holder should use the appropriate form and pay for the change fee.

Q: Does it require CE certificate for medical device registration in Pakistan?

A: Yes

Q: Is Pakistan medical Device registration a "sole representative"?

A: According to regulation S.R.O.32(I)/2018, manufacturers operating outside Pakistan shall authorize a sole representative in Pakistan.

Q: How to clear Class A product at Pakistan Customs?

A: For clearance of Class A medical devices at Pakistan Customs, the importer must submit a notarized (ISO.13485) and notarized authorization letter from the foreign manufacturer and any one of the following documents, namely

① Notarized certificate of free sale in the country of origin; or

② Notarized declaration of conformity issued by foreign manufacturers; or

③ Production or total quality assurance certificate issued by a notarized conformity assessment body (CAB)

Q: How to clear Class B/C/D product at Pakistan Customs?

A: For clearance of Class B/C/D medical devices at Pakistan Customs, the importer must submit a notarized (ISO.13485) and notarized authorization letter from the foreign manufacturer and any one of the following documents, namely

① Notarized country of origin free sale certificate and declaration of conformity, complete quality assurance certificate of CAB (CE mark certificate). However, for Class D medical devices, the design audit certificate is also mandatory; or

②A notarized certificate of free sale from any of the reference countries, namely, the United States, Japan, Australia, Canada, Austria, Belgium, Denmark, France, Germany, Ireland, Italy, the Netherlands, Norway, Spain, Sweden, Switzerland, the United Kingdom; or

③A notarized certificate of free sale in the country of origin and WHO prequalification status; and

④In order to clear raw materials for local manufacturing of medical devices at Pakistan Customs, it is necessary to have a valid establishment license for local manufacturing of medical devices issued in accordance with these rules.

Q: How to achieve producing locally in Pakistan?

A: Application for production enterprise license information includes enterprise name, address, ownership type, business registration information, partner/owner/director information, production site details, equipment and machinery details, qualified technical personnel qualifications and other content. Pay the required fee (100,000 rupees). Submit to the Medical Device Board (MDB) for audit, including site inspection, document audit, etc., to ensure that the enterprise meets relevant requirements, such as having a suitable site, sufficient equipment, qualified technical personnel, and a thorough quality control system.